This 4-year study will compare how safe and effective an oral investigational medicine is (compared to placebo) in preventing the development of prostate cancer in men that are defined by the study entrance criteria as being at an increased risk for prostate cancer. Study visits to the clinic will occur every 6 months for up to 4 years (10 clinic visits), and a prostate biopsy will be performed at 2 and 4 years of treatment.

Condition	Treatment or Intervention	Phase
Prostate Cancer	Drug: Oral investigational prostate cancer risk reduction drug	Phase III

Ages Eligible for Study:  50 Years   -   75 Years,  Genders Eligible for Study:  Male

Criteria

Inclusion criteria:

• Informed consent to participate in study.
• Have had a single negative prostate biopsy within 6 months prior to enrollment in study.
• Have a PSA (prostate specific antigen) between 2.5 and 10 if 50-60 years of age; or a PSA between 3.0 and 10 if over age 60.
• Ability and will to participate in study for 4 years.

Exclusion criteria:

• More than one previous negative prostate biopsy.
• History of prostate cancer.
• Previous prostate surgery.
• Inability to urinate requiring the need of a catheter during the previous 2 years.
• Any condition (other than benign prostatic hypertrophy) which may result in urinary symptoms or changes in urine flow rate.
• Cancer within previous 5 years (other than basal or squamous cell cancers of the skin).
• Any unstable serious medical condition.
• Use within the past 12 months of finasteride (Proscar or Propecia), dutasteride (Avodart), testosterone, or drugs that can block the action of male hormones.

Alabama
      Columbiana,  Alabama,  35051,  United States; Terminated
      Birmingham,  Alabama,  35205,  United States; Recruiting
      Homewood,  Alabama,  35209,  United States; Recruiting
      Birmingham,  Alabama,  35209,  United States; Recruiting
      Huntsville,  Alabama,  35801,  United States; Terminated
      Mobile,  Alabama,  36608,  United States; Recruiting
Alaska
      Anchorage,  Alaska,  99508,  United States; Recruiting
Arizona
      Phoenix,  Arizona,  85023,  United States; Recruiting
      Phoenix,  Arizona,  85032,  United States; Recruiting
      Tucson,  Arizona,  85712,  United States; Recruiting
Arkansas
      Little Rock,  Arkansas,  72205,  United States; Recruiting
      Little Rock,  Arkansas,  72211,  United States; Recruiting
California
      Los Angeles,  California,  90024,  United States; Terminated
      Los Angeles,  California,  90033,  United States; Terminated
      Los Angeles,  California,  90045,  United States; Recruiting
      Los Angeles,  California,  90048,  United States; Not yet recruiting
      Los Angeles,  California,  90048,  United States; Terminated
      Los Angeles,  California,  90059,  United States; Terminated
      Los Angeles,  California,  90073,  United States; Recruiting
      Los Angeles,  California,  90095,  United States; Terminated
      Culver City,  California,  90232,  United States; Recruiting
      Santa Monica,  California,  90404,  United States; Recruiting
      Torrance,  California,  90505,  United States; Recruiting
      Pico Rivera,  California,  90660,  United States; Recruiting
      Long Beach,  California,  90806,  United States; Recruiting
      Granada Hills,  California,  91344,  United States; Recruiting
      Van Nuys,  California,  91405,  United States; Recruiting
      Upland,  California,  91786,  United States; Recruiting
      La Mesa,  California,  91942,  United States; Recruiting
      Poway,  California,  92064,  United States; Recruiting
      San Diego,  California,  92101,  United States; Recruiting
      San Diego,  California,  92103,  United States; Recruiting
      San Diego,  California,  92120,  United States; Recruiting
      San Diego,  California,  92120,  United States; Terminated
      San Diego,  California,  92128,  United States; Recruiting
      San Bernardino,  California,  92404,  United States; Recruiting
      Murrieta,  California,  92562,  United States; Recruiting
      Irvine,  California,  92618,  United States; Terminated
      Laguna Woods,  California,  92653,  United States; Recruiting
      Newport Beach,  California,  92660,  United States; Recruiting
      Fountain Valley,  California,  92708,  United States; Terminated
      Anaheim,  California,  92801,  United States; Recruiting
      Anaheim,  California,  92801,  United States; Recruiting
      Fresno,  California,  93720,  United States; Recruiting
      Atherton,  California,  94027,  United States; Recruiting
      San Francisco,  California,  94108,  United States; Recruiting
      San Francisco,  California,  94121,  United States; Recruiting
      Standford,  California,  94305,  United States; Recruiting
      Walnut Creek,  California,  94598,  United States; Terminated
      Mather,  California,  95655,  United States; Recruiting
      Sacramento,  California,  95816,  United States; Terminated
Colorado
      Aurora,  Colorado,  80012,  United States; Recruiting
      Wheat Ridge,  Colorado,  80033,  United States; Recruiting
      Denver,  Colorado,  80210,  United States; Recruiting
      Denver,  Colorado,  80220,  United States; Recruiting
      Longmont,  Colorado,  80501,  United States; Recruiting
Connecticut
      New Britain,  Connecticut,  06052,  United States; Recruiting
      Hartford,  Connecticut,  06106,  United States; Recruiting
      Trumbull,  Connecticut,  06611,  United States; Recruiting
      Waterbury,  Connecticut,  06708,  United States; Recruiting
District of Columbia
      Washington,  District of Columbia,  20307,  United States; Recruiting
Florida
      Orange Park,  Florida,  32073,  United States; Terminated
      Port Orange,  Florida,  32127,  United States; Recruiting
      Jacksonville,  Florida,  32216,  United States; Recruiting
      Jacksonville,  Florida,  32224,  United States; Recruiting
      Tallahassee,  Florida,  32308,  United States; Recruiting
      Panama City,  Florida,  32405,  United States; Recruiting
      Longwood,  Florida,  32750,  United States; Recruiting
      Orlando,  Florida,  32803,  United States; Recruiting
      Melbourne,  Florida,  32901,  United States; Recruiting
      Melbourne,  Florida,  32904,  United States; Terminated
      Melbourne,  Florida,  32955,  United States; Recruiting
      Margate,  Florida,  33063,  United States; Recruiting
      Pinecrest,  Florida,  33156,  United States; Recruiting
      Aventura,  Florida,  33180,  United States; Recruiting
      Plantation,  Florida,  33317,  United States; Not yet recruiting
      Tamarack,  Florida,  33321,  United States; Recruiting
      West Palm Beach,  Florida,  33409,  United States; Recruiting
      Lake Worth,  Florida,  33461,  United States; Recruiting
      Delray Beach,  Florida,  33484,  United States; Recruiting
      St. Petersburg,  Florida,  33701,  United States; Recruiting
      St. Petersburg,  Florida,  33703,  United States; Recruiting
      Clearwater,  Florida,  33756,  United States; Recruiting
      Clearwater,  Florida,  33761,  United States; Recruiting
      Clearwater,  Florida,  33761,  United States; Recruiting
      Fort Myers,  Florida,  33916,  United States; Recruiting
      Sarasota,  Florida,  34237,  United States; Recruiting
      Ocala,  Florida,  34470,  United States; Recruiting
      Ocala,  Florida,  34474,  United States; Recruiting
      New Port Richey,  Florida,  34652,  United States; Recruiting
      Okeechobee,  Florida,  34972,  United States; Recruiting
      Stuart,  Florida,  34996,  United States; Recruiting
Georgia
      Marietta,  Georgia,  30060,  United States; Recruiting
      Roswell,  Georgia,  30076,  United States; Recruiting
      Woodstock,  Georgia,  30189,  United States; Recruiting
      Fayetteville,  Georgia,  30214,  United States; Recruiting
      Atlanta,  Georgia,  30308,  United States; Recruiting
      Atlanta,  Georgia,  30309,  United States; Recruiting
      Atlanta,  Georgia,  30342,  United States; Recruiting
      Atlanta,  Georgia,  30342,  United States; Terminated
      Augusta,  Georgia,  30912,  United States; Recruiting
Hawaii
      Honolulu,  Hawaii,  96813,  United States; Terminated
Idaho
      Coeur D Alene,  Idaho,  83814,  United States; Recruiting
Illinois
      Maywood,  Illinois,  60153,  United States; Terminated
      Melrose Park,  Illinois,  60160,  United States; Recruiting
      Chicago,  Illinois,  60612,  United States; Recruiting
      Chicago,  Illinois,  60612,  United States; Recruiting
      Chicago,  Illinois,  60616,  United States; Recruiting
      Chicago,  Illinois,  60637,  United States; Recruiting
      Chicago,  Illinois,  60640,  United States; Terminated
      Niles,  Illinois,  60714,  United States; Recruiting
      Kankakee,  Illinois,  60901,  United States; Recruiting
      Springfield,  Illinois,  62702,  United States; Recruiting
Indiana
      Indianapolis,  Indiana,  46202,  United States; Recruiting
      Indianapolis,  Indiana,  46254,  United States; Recruiting
      Fort Wayne,  Indiana,  46825,  United States; Recruiting
      Jeffersonville,  Indiana,  47130,  United States; Recruiting
Kansas
      Kansas City,  Kansas,  66160,  United States; Terminated
      Overland Park,  Kansas,  66215,  United States; Recruiting
Kentucky
      Lexington,  Kentucky,  40508,  United States; Recruiting
Louisiana
      Metairie,  Louisiana,  70001,  United States; Terminated
      Gretna,  Louisiana,  70056,  United States; Recruiting
      New Orleans,  Louisiana,  70112,  United States; Not yet recruiting
      New Orleans,  Louisiana,  70112,  United States; Terminated
      New Orleans,  Louisiana,  70115,  United States; Terminated
      New Orleans,  Louisiana,  70115,  United States; Recruiting
      New Orleans,  Louisiana,  70119,  United States; Terminated
      New Orleans,  Louisiana,  70121,  United States; Recruiting
      Houma,  Louisiana,  70360,  United States; Terminated
      Covington,  Louisiana,  70433,  United States; Recruiting
      Lafayette,  Louisiana,  70503,  United States; Recruiting
      Shreveport,  Louisiana,  71106,  United States; Recruiting
      Ruston,  Louisiana,  71270,  United States; Recruiting
Maryland
      Greenbelt,  Maryland,  20770,  United States; Recruiting
      Rockville,  Maryland,  20850,  United States; Recruiting
      Glen Burnie,  Maryland,  21061,  United States; Recruiting
      Owings Mills,  Maryland,  21117,  United States; Recruiting
      Baltimore,  Maryland,  21201,  United States; Recruiting
      Baltimore,  Maryland,  21204,  United States; Recruiting
      Annapolis,  Maryland,  21401,  United States; Recruiting
Massachusetts
      Springfield,  Massachusetts,  01107,  United States; Terminated
      West Boylston,  Massachusetts,  01583,  United States; Recruiting
      Milford,  Massachusetts,  01757,  United States; Recruiting
      Salisbury,  Massachusetts,  01952,  United States; Recruiting
      Peabody,  Massachusetts,  01952,  United States; Recruiting
      Boston,  Massachusetts,  02115,  United States; Recruiting
      Stoneham,  Massachusetts,  02180,  United States; Terminated
      Braintree,  Massachusetts,  02184,  United States; Recruiting
      Waltham,  Massachusetts,  02453,  United States; Recruiting
      Newton,  Massachusetts,  02462,  United States; Recruiting
      Watertown,  Massachusetts,  02472,  United States; Recruiting
      Hyannis,  Massachusetts,  02601,  United States; Terminated
      West Yarmouth,  Massachusetts,  02673,  United States; Recruiting
Michigan
      Royal Oak,  Michigan,  48073,  United States; Recruiting
      Ann Arbor,  Michigan,  48106,  United States; Recruiting
      Detroit,  Michigan,  48202,  United States; Recruiting
      St. Joseph,  Michigan,  49085,  United States; Recruiting
Minnesota
      Chaska,  Minnesota,  55318,  United States; Recruiting
      Minneapolis,  Minnesota,  55407,  United States; Recruiting
      St. Louis Park,  Minnesota,  55426,  United States; Recruiting
      Rochester,  Minnesota,  55905,  United States; Recruiting
      St. Cloud,  Minnesota,  56303,  United States; Recruiting
Mississippi
      Jackson,  Mississippi,  39202,  United States; Recruiting
      Hattiesburg,  Mississippi,  39401,  United States; Recruiting
Missouri
      St. Louis,  Missouri,  63110,  United States; Terminated
      St. Louis,  Missouri,  63136,  United States; Recruiting
      St. Louis,  Missouri,  63141,  United States; Terminated
      St. Louis,  Missouri,  63141,  United States; Recruiting
      Kansas City,  Missouri,  64131,  United States; Recruiting
Montana
      Billings,  Montana,  59102,  United States; Recruiting
Nebraska
      Omaha,  Nebraska,  68131,  United States; Recruiting
Nevada
      Henderson,  Nevada,  89014,  United States; Recruiting
      Las Vegas,  Nevada,  89109,  United States; Recruiting
      Reno,  Nevada,  89511,  United States; Recruiting
New Hampshire
      Lebanon,  New Hampshire,  03756,  United States; Terminated
New Jersey
      West Orange,  New Jersey,  07052,  United States; Recruiting
      Hackensack,  New Jersey,  07601,  United States; Recruiting
      Morristown,  New Jersey,  07960,  United States; Not yet recruiting
      Voorhees,  New Jersey,  08043,  United States; Recruiting
      Marlton,  New Jersey,  08053,  United States; Recruiting
      Stratford,  New Jersey,  08084,  United States; Terminated
      Marlton,  New Jersey,  08096,  United States; Recruiting
      Lawrenceville,  New Jersey,  08648,  United States; Recruiting
New York
      New York,  New York,  10016,  United States; Recruiting
      New York,  New York,  10016,  United States; Recruiting
      New York,  New York,  10021,  United States; Recruiting
      New York,  New York,  10032,  United States; Not yet recruiting
      New York,  New York,  10032,  United States; Terminated
      Staten Island,  New York,  10304,  United States; Recruiting
      Bronx,  New York,  10467,  United States; Recruiting
      Elmont,  New York,  11003,  United States; Recruiting
      Great Neck,  New York,  11021,  United States; Recruiting
      Great Neck,  New York,  11021,  United States; Recruiting
      Brooklyn,  New York,  11234,  United States; Recruiting
      Mineola,  New York,  11501,  United States; Recruiting
      Garden City,  New York,  11530,  United States; Recruiting
      Garden City,  New York,  11530,  United States; Recruiting
      Albany,  New York,  12208,  United States; Recruiting
      Poughkeepsie,  New York,  12601,  United States; Recruiting
      East Syracuse,  New York,  13057,  United States; Recruiting
      Syracuse,  New York,  13210,  United States; Terminated
      Syracuse,  New York,  13210,  United States; Recruiting
      Endwell,  New York,  13760,  United States; Recruiting
      Binghamton,  New York,  13901,  United States; Terminated
      Orchard Park,  New York,  14127,  United States; Recruiting
      Rochester,  New York,  14642,  United States; Recruiting
North Carolina
      Winston Salem,  North Carolina,  27103,  United States; Recruiting
      Cary,  North Carolina,  27511,  United States; Recruiting
      Cary,  North Carolina,  27511,  United States; Recruiting
      Chapel Hill,  North Carolina,  27514,  United States; Recruiting
      Raleigh,  North Carolina,  27607,  United States; Recruiting
      Raleigh,  North Carolina,  27612,  United States; Recruiting
      Durham,  North Carolina,  27710,  United States; Recruiting
      Greenville,  North Carolina,  27834,  United States; Not yet recruiting
      Concord,  North Carolina,  28025,  United States; Recruiting
      Charlotte,  North Carolina,  28204,  United States; Recruiting
      Charlotte,  North Carolina,  28211,  United States; Terminated
      Charlotte,  North Carolina,  28262,  United States; Recruiting
North Dakota
      Bismarck,  North Dakota,  58501,  United States; Not yet recruiting
Ohio
      Columbus,  Ohio,  43214,  United States; Recruiting
      Columbus,  Ohio,  43214,  United States; Recruiting
      Columbus,  Ohio,  43235,  United States; Recruiting
      Marion,  Ohio,  43302,  United States; Recruiting
      Toledo,  Ohio,  43614,  United States; Terminated
      Zanesville,  Ohio,  43701,  United States; Recruiting
      Sheffield,  Ohio,  44035,  United States; Recruiting
      Cleveland,  Ohio,  44195,  United States; Terminated
      Cincinnati,  Ohio,  45212,  United States; Recruiting
      Cincinnati,  Ohio,  45267,  United States; Recruiting
      Kettering,  Ohio,  45429,  United States; Recruiting
Oklahoma
      Oklahoma City,  Oklahoma,  73112,  United States; Recruiting
      Tulsa,  Oklahoma,  74104,  United States; Recruiting
      Tulsa,  Oklahoma,  74131,  United States; Recruiting
      Poca City,  Oklahoma,  74601,  United States; Recruiting
Oregon
      Oregon City,  Oregon,  97045,  United States; Recruiting
      Portland,  Oregon,  97205,  United States; Recruiting
      Portland,  Oregon,  97210,  United States; Recruiting
      Portland,  Oregon,  97213,  United States; Recruiting
      Eugene,  Oregon,  97401,  United States; Recruiting
Pennsylvania
      Bryn Mawr,  Pennsylvania,  10910,  United States; Recruiting
      Monroeville,  Pennsylvania,  15146,  United States; Recruiting
      Pittsburgh,  Pennsylvania,  15212,  United States; Recruiting
      Pittsburgh,  Pennsylvania,  15232,  United States; Recruiting
      State College,  Pennsylvania,  16801,  United States; Recruiting
      Camp Hill,  Pennsylvania,  17011,  United States; Recruiting
      Camp Hill,  Pennsylvania,  17011,  United States; Recruiting
      Hershey,  Pennsylvania,  17033,  United States; Recruiting
      Harrisburg,  Pennsylvania,  17110,  United States; Recruiting
      Lancaster,  Pennsylvania,  17601,  United States; Recruiting
      Lancaster,  Pennsylvania,  17604,  United States; Recruiting
      Newtown,  Pennsylvania,  18940,  United States; Terminated
      Sellersville,  Pennsylvania,  18960,  United States; Recruiting
      Bala Cynwyd,  Pennsylvania,  19004,  United States; Recruiting
      Bryn Mawr,  Pennsylvania,  19010,  United States; Recruiting
      Philadelphia,  Pennsylvania,  19107,  United States; Recruiting
      Philadelphia,  Pennsylvania,  19115,  United States; Terminated
      Philadelphia,  Pennsylvania,  19124,  United States; Recruiting
      Philadelphia,  Pennsylvania,  19141,  United States; Recruiting
Rhode Island
      West Warwick,  Rhode Island,  02893,  United States; Terminated
      Providence,  Rhode Island,  02904,  United States; Recruiting
      Providence,  Rhode Island,  02906,  United States; Terminated
      Cranston,  Rhode Island,  02920,  United States; Recruiting
      Providence,  Rhode Island,  2904,  United States; Recruiting
South Carolina
      Charleston,  South Carolina,  29425,  United States; Recruiting
      Myrtle Beach,  South Carolina,  29572,  United States; Recruiting
      Greer,  South Carolina,  29650,  United States; Recruiting
      Greer,  South Carolina,  29651,  United States; Recruiting
      Simpsonville,  South Carolina,  29681,  United States; Recruiting
South Dakota
      Ft. Pierre,  South Dakota,  57501,  United States; Recruiting
Tennessee
      Nashville,  Tennessee,  37209,  United States; Recruiting
      Nashville,  Tennessee,  37232,  United States; Recruiting
      Knoxville,  Tennessee,  37920,  United States; Terminated
      Mamphis,  Tennessee,  38119,  United States; Recruiting
      Germantown,  Tennessee,  38138,  United States; Recruiting
      Milan,  Tennessee,  38358,  United States; Recruiting
Texas
      Dallas,  Texas,  75216,  United States; Recruiting
      Dallas,  Texas,  75230,  United States; Recruiting
      Dallas,  Texas,  75231,  United States; Recruiting
      Dallas,  Texas,  75234,  United States; Recruiting
      Dallas,  Texas,  75390,  United States; Recruiting
      Texarkama,  Texas,  75501,  United States; Recruiting
      Arlington,  Texas,  76017,  United States; Recruiting
      Fort Worth,  Texas,  76104,  United States; Recruiting
      Fort Worth,  Texas,  76107,  United States; Recruiting
      Houston,  Texas,  77024,  United States; Recruiting
      Houston,  Texas,  77030,  United States; Recruiting
      Houston,  Texas,  77033,  United States; Recruiting
      Galveston,  Texas,  77555,  United States; Terminated
      San Antonio,  Texas,  78229,  United States; Recruiting
      San Antonio,  Texas,  78229,  United States; Recruiting
      San Antonio,  Texas,  78229,  United States; Recruiting
      Austin,  Texas,  78756,  United States; Recruiting
      Amarillo,  Texas,  79106,  United States; Recruiting
Utah
      Salt Lake City,  Utah,  84124,  United States; Recruiting
Vermont
      South Burlington,  Vermont,  05403,  United States; Recruiting
Virginia
      Fairfax,  Virginia,  22031,  United States; Recruiting
      Alexandria,  Virginia,  22302,  United States; Terminated
      Harrisonburg,  Virginia,  22801,  United States; Recruiting
      Charlottesville,  Virginia,  22911,  United States; Recruiting
      Richmond,  Virginia,  23235,  United States; Recruiting
      Richmond,  Virginia,  23249,  United States; Recruiting
      Richmond,  Virginia,  23298,  United States; Terminated
      Norfolk,  Virginia,  23454,  United States; Recruiting
      Virginia Beach,  Virginia,  23455,  United States; Recruiting
      Norfolk,  Virginia,  23502,  United States; Recruiting
      Norfolk,  Virginia,  23502,  United States; Recruiting
      Salem,  Virginia,  24153,  United States; Terminated
Washington
      Seattle,  Washington,  98101,  United States; Recruiting
      Seattle,  Washington,  98104,  United States; Recruiting
      Seattle,  Washington,  98108,  United States; Terminated
      Seattle,  Washington,  98133,  United States; Recruiting
      Seattle,  Washington,  98166,  United States; Recruiting
      Seattle,  Washington,  98195,  United States; Not yet recruiting
      Graham,  Washington,  98338,  United States; Terminated
      Tacoma,  Washington,  98405,  United States; Recruiting
      Tacoma,  Washington,  98431,  United States; Recruiting
      Lakewood,  Washington,  98499,  United States; Terminated
      Spokane,  Washington,  99204,  United States; Recruiting
      Spokane,  Washington,  99207,  United States; Recruiting
West Virginia
      Wheeling,  West Virginia,  26003,  United States; Not yet recruiting
Wisconsin
      Milwaukee,  Wisconsin,  53209,  United States; Recruiting
      Milwaukee,  Wisconsin,  53209,  United States; Recruiting
      Milwaukee,  Wisconsin,  53215,  United States; Recruiting
      Madison,  Wisconsin,  53715,  United States; Recruiting
Wyoming
      Cheyenne,  Wyoming,  82001,  United States; Recruiting
Australia, New South Wales
      Darlinghurst,  New South Wales,  2010,  Australia; Recruiting
Australia, South Australia
      Adelaide,  South Australia,  5000,  Australia; Recruiting
Australia, Victoria
      Randwick,  Victoria,  2031,  Australia; Recruiting
      Parkville,  Victoria,  3050,  Australia; Not yet recruiting
      Mentone,  Victoria,  3194,  Australia; Not yet recruiting
Austria
      Wien,  A 1090,  Austria; Recruiting
      Wien,  A 1180,  Austria; Recruiting
      Innsbruck,  A 6020,  Austria; Recruiting
      Wien,  A-1090,  Austria; Recruiting
Belgium
      Brussels,  1070,  Belgium; Recruiting
      Brussels,  1200,  Belgium; Recruiting
      Antwerpen,  2020,  Belgium; Recruiting
      Leuven,  3000,  Belgium; Recruiting
Canada, Alberta
      Calgary,  Alberta,  T2V 4R6,  Canada; Recruiting
      Red Deer,  Alberta,  T4N 4E7,  Canada; Not yet recruiting
      Edmonton,  Alberta,  T6G 2C8,  Canada; Recruiting
Canada, British Columbia
      Kelowna,  British Columbia,  V1Y 2H4,  Canada; Recruiting
      Surrey,  British Columbia,  V3V 1N1,  Canada; Recruiting
      Vancouver,  British Columbia,  V5Z 3J5,  Canada; Recruiting
      Victoria,  British Columbia,  V8T 5G1,  Canada; Recruiting
      Victoria,  British Columbia,  V8V 3N1,  Canada; Recruiting
Canada, New Brunswick
      Miramichi,  New Brunswick,  E1V 1N9,  Canada; Recruiting
      Saint John,  New Brunswick,  E2L 3J8,  Canada; Recruiting
      Fredericton,  New Brunswick,  E3B 5B8,  Canada; Recruiting
Canada, Nova Scotia
      Halifax,  Nova Scotia,  B3H 1Y6,  Canada; Recruiting
      Kentville,  Nova Scotia,  B4N 4K9,  Canada; No longer recruiting
Canada, Ontario
      Kingston,  Ontario,  K7L 2V7,  Canada; Recruiting
      Niagara Falls,  Ontario,  L2E 7H1,  Canada; Recruiting
      Orillia,  Ontario,  L3V 7V1,  Canada; Recruiting
      Newmarket,  Ontario,  L3X 1W1,  Canada; Recruiting
      Richmond Hill,  Ontario,  L4C 1T6,  Canada; Recruiting
      Barrie,  Ontario,  L4M 4S5,  Canada; Recruiting
      Markham,  Ontario,  L6B 1A1,  Canada; Recruiting
      Oakville,  Ontario,  L6H 3P1,  Canada; Recruiting
      Brampton,  Ontario,  L6T 3J1,  Canada; Recruiting
      Burlington,  Ontario,  L7N 3V2,  Canada; Recruiting
      Burlington,  Ontario,  L7S 1V2,  Canada; Recruiting
      Toronto,  Ontario,  M1S 4V5,  Canada; Recruiting
      Toronto,  Ontario,  M3H 5S4,  Canada; Recruiting
      Study Site - North Toronto, Toronto,  Ontario,  M4N 3M5,  Canada; Recruiting
      Study Site - Central Toronto, Toronto,  Ontario,  M5G 2M9,  Canada; Recruiting
      Study Site - North Toronto, Toronto,  Ontario,  M6A 3B5,  Canada; Recruiting
      Kitchener,  Ontario,  N2M 5N4,  Canada; Recruiting
      North Bay,  Ontario,  P1B 4Z2,  Canada; Recruiting
Canada, Quebec
      Quebec City,  Quebec,  G1S 2L6,  Canada; Recruiting
      Chicoutimi,  Quebec,  G7H 1H2,  Canada; Recruiting
      Trois-Rivieres,  Quebec,  G9A 3V7,  Canada; Recruiting
      Study Site - East Montreal, Montreal,  Quebec,  H1T 2M4,  Canada; Recruiting
      Study Site - Downtown Montreal, Montreal,  Quebec,  H2L 4M1,  Canada; Recruiting
      Study Site - Downtown Montreal, Montreal,  Quebec,  H2X 3J4,  Canada; Recruiting
      Study Site - West Montreal, Montreal,  Quebec,  H3A 1A1,  Canada; No longer recruiting
      Study Site - West Montreal, Montreal,  Quebec,  H3S 1Z1,  Canada; Recruiting
      Montreal,  Quebec,  H4A 1S9,  Canada; Recruiting
      Laval,  Quebec,  H7G 2E6,  Canada; Recruiting
      Pointe-Claire,  Quebec,  H9R 4S3,  Canada; Recruiting
      Granby,  Quebec,  J2G 8Z9,  Canada; Recruiting
      Greenfield Park,  Quebec,  J4V 2H3,  Canada; Recruiting
Croatia
      Zagreb,  10 000,  Croatia; Not yet recruiting
      Zagreb,  10 000,  Croatia; Not yet recruiting
Finland
      Helsinki,  00029,  Finland; Recruiting
      Helsinki,  00530,  Finland; Recruiting
      Lahti,  15800,  Finland; Not yet recruiting
      Turku,  20100,  Finland; Not yet recruiting
      Tampere,  33520,  Finland; Recruiting
      Seinajoki,  60220,  Finland; Recruiting
      Kuopio,  70100,  Finland; Recruiting
      Oulu,  90029,  Finland; Recruiting
      Oulu,  90100,  Finland; Recruiting
France
      Dijon,  21000,  France; Not yet recruiting
      Dijon,  21034,  France; Not yet recruiting
      Besancon,  25030,  France; Not yet recruiting
      Toulouse,  31403,  France; Not yet recruiting
      Bordeaux,  33000,  France; Not yet recruiting
      Montpellier,  34000,  France; Not yet recruiting
      Rennes,  35700,  France; Not yet recruiting
      Fourmies Cedex,  59611,  France; Not yet recruiting
      Lyon,  69437,  France; Not yet recruiting
      Pierre-Benite,  69495,  France; Not yet recruiting
      Chalon-sur-Saone,  71100,  France; Not yet recruiting
      Paris,  75475,  France; Not yet recruiting
      Paris,  75743,  France; Not yet recruiting
      Paris,  75877,  France; Not yet recruiting
      Rouen,  76000,  France; Not yet recruiting
      Poitiers,  86021,  France; Not yet recruiting
      Creteil,  94000,  France; Not yet recruiting
Germany
      Dresden,  01309,  Germany; Recruiting
      Senftenberg,  01968,  Germany; Recruiting
      Bautzen,  02625,  Germany; Recruiting
      Leipzig,  04105,  Germany; Recruiting
      Grimma,  04668,  Germany; Recruiting
      Eisleben,  06295,  Germany; Recruiting
      Hettstedt,  06333,  Germany; Recruiting
      Dessau,  06842,  Germany; Recruiting
      Dessau,  06844,  Germany; Recruiting
      Berlin,  10365,  Germany; Recruiting
      Berlin,  10713,  Germany; Recruiting
      Berlin,  10719,  Germany; Recruiting
      Berlin,  10787,  Germany; Recruiting
      Berlin,  12099,  Germany; Recruiting
      Berlin,  12107,  Germany; Recruiting
      Berlin,  13187,  Germany; Recruiting
      Berlin,  13347,  Germany; Recruiting
      Berlin,  13507,  Germany; Recruiting
      Berlin,  14057,  Germany; Recruiting
      Strausberg,  15344,  Germany; Recruiting
      Schwedt,  16303,  Germany; Recruiting
      Oranienburg,  16515,  Germany; Recruiting
      Hennigsdorf,  16761,  Germany; Recruiting
      Bad Doberan,  18209,  Germany; Recruiting
      Hagenow,  19230,  Germany; Recruiting
      Wismar,  23970,  Germany; Recruiting
      Kiel,  24143,  Germany; Recruiting
      Plon,  24306,  Germany; Recruiting
      Leer (Ostfriesland),  26789,  Germany; Recruiting
      Bremervorde,  27432,  Germany; Recruiting
      Ganderkesee,  27777,  Germany; Recruiting
      Hildesheim,  31134,  Germany; Recruiting
      Marburg,  35039,  Germany; Recruiting
      Gottingen,  37073,  Germany; Recruiting
      Braunschweig,  38100,  Germany; Recruiting
      Wolfsburg,  38440,  Germany; Recruiting
      Magdeburg,  39104,  Germany; Recruiting
      Wolmirstedt,  39326,  Germany; Recruiting
      Stendal,  39576,  Germany; Recruiting
      Gardelegen,  39638,  Germany; Recruiting
      Monchengladbach,  41061,  Germany; Recruiting
      Wuppertal,  42103,  Germany; Recruiting
      Wuppertal,  42275,  Germany; Recruiting
      Dortmund,  44137,  Germany; Recruiting
      ESSEN,  45127,  Germany; Recruiting
      ESSEN,  45395,  Germany; Recruiting
      Mulheim an der Ruhr,  45475,  Germany; Recruiting
      Gelsenkirchen,  45894,  Germany; Recruiting
      Oberhausen,  46045,  Germany; Recruiting
      Borken,  46325,  Germany; Recruiting
      Bocholt,  46399,  Germany; Recruiting
      Duisburg,  47051,  Germany; Recruiting
      Duisburg,  47179,  Germany; Recruiting
      Duisburg,  47198,  Germany; Recruiting
      Moers,  47445,  Germany; Recruiting
      Kamp-Lintfort,  47475,  Germany; Recruiting
      Krefeld,  47798,  Germany; Recruiting
      Krefeld,  47803,  Germany; Recruiting
      Koln,  50969,  Germany; Recruiting
      Konigswinter,  53639,  Germany; Recruiting
      Frankfurt am Main,  60326,  Germany; Recruiting
      Frankfurt am Main,  60594,  Germany; Recruiting
      Bad Homburg,  61348,  Germany; Recruiting
      Rodgau,  63110,  Germany; Recruiting
      Wiesbaden,  65185,  Germany; Recruiting
      Hochheim,  65239,  Germany; Recruiting
      Frankfurt am Main,  65929,  Germany; Recruiting
      Kleinblittersdorf,  66271,  Germany; Recruiting
      Homburg,  66424,  Germany; Not yet recruiting
      Backnang,  71522,  Germany; Recruiting
      Esslingen am Neckar,  73728,  Germany; Recruiting
      Bruchsal,  76646,  Germany; Recruiting
      Waldkirch,  79183,  Germany; Recruiting
      Rheinfelden,  79618,  Germany; Recruiting
      Munchen,  80336,  Germany; Recruiting
      Starnberg,  82319,  Germany; Recruiting
      Garmisch-Partenkirchen,  82467,  Germany; Recruiting
      Rosenheim,  83022,  Germany; Recruiting
      Dachau,  85221,  Germany; Recruiting
      Augsburg,  86150,  Germany; Recruiting
      Augsburg,  86156,  Germany; Recruiting
      Nurnberg,  90459,  Germany; Recruiting
      Furth,  90762,  Germany; Recruiting
      Furth,  90762,  Germany; Recruiting
      Roth,  91154,  Germany; Recruiting
      Ansbach,  91522,  Germany; Recruiting
      WeiBenburg,  91781,  Germany; Recruiting
      Neumarkt,  92318,  Germany; Recruiting
      Bamberg,  96052,  Germany; Recruiting
      Waltershausen,  99880,  Germany; Recruiting
Greece
      Athens,  105 52,  Greece; Recruiting
      Athens,  106 76,  Greece; Not yet recruiting
      Athens,  115 26,  Greece; Not yet recruiting
      Athens,  115 26,  Greece; Recruiting
      Athens,  115 27,  Greece; Not yet recruiting
      Athens,  156 69,  Greece; Recruiting
      Athens,  156 69,  Greece; Not yet recruiting
      Piraeus,  184 54,  Greece; Not yet recruiting
      Piraeus,  185 37,  Greece; Recruiting
      Patras,  265 00,  Greece; Recruiting
      Larisa,  411 10,  Greece; Not yet recruiting
      Ioannina,  455 00,  Greece; Not yet recruiting
      THESSALONIKI,  546 35,  Greece; Not yet recruiting
Ireland
      Dublin,  D24,  Ireland; Not yet recruiting
      Dublin,  D4,  Ireland; Not yet recruiting
      Dublin,  D7,  Ireland; Not yet recruiting
Italy
      Albano Laziale,  00041,  Italy; Not yet recruiting
      Roma,  00161,  Italy; Not yet recruiting
      Cagliari,  09100,  Italy; Not yet recruiting
      Milano,  20132,  Italy; Not yet recruiting
      Lanciano,  66034,  Italy; Not yet recruiting
      Bari,  70124,  Italy; Not yet recruiting
      Catania,  95124,  Italy; Not yet recruiting
Japan
      Sapporo,  060 8543,  Japan; Not yet recruiting
      Ibaraki,  305 8576,  Japan; Not yet recruiting
Latvia
      Riga,  LV1001,  Latvia; Not yet recruiting
      Riga,  LV1002,  Latvia; Recruiting
      Riga,  LV1006,  Latvia; Recruiting
      Riga,  LV1038,  Latvia; Recruiting
      Riga,  LV1079,  Latvia; Not yet recruiting
Netherlands
      Amsterdam,  1091 HA,  Netherlands; Recruiting
      Den Haag,  2512 VA,  Netherlands; Recruiting
      Nieuwegein,  3435 CM,  Netherlands; Recruiting
      Harderwijk,  3844 DG,  Netherlands; Recruiting
      Tilburg,  5022 GC,  Netherlands; Not yet recruiting
      Eindhoven,  5623 EJ,  Netherlands; Recruiting
      Roermond,  6043 CV,  Netherlands; Recruiting
      Nijmegen,  6525 GA,  Netherlands; Recruiting
      Nijmegen,  6532 SZ,  Netherlands; Recruiting
      Ede,  6716 RP,  Netherlands; Recruiting
      ARNHEM,  6815 AD,  Netherlands; Not yet recruiting
      Stadskanaal,  9501 HE,  Netherlands; Recruiting
New Zealand
      Auckland,  1006,  New Zealand; Not yet recruiting
      Tauranga,  3001,  New Zealand; Not yet recruiting
      Nelson,  7001,  New Zealand; Not yet recruiting
      Christchurch,  8001,  New Zealand; Not yet recruiting
Norway
      Fredrikstad,  1606,  Norway; Not yet recruiting
      Porsgrunn,  3906,  Norway; Not yet recruiting
      Stavanger,  4011,  Norway; Recruiting
      Arendal,  4808,  Norway; Not yet recruiting
Poland
      Warszawa,  02 005,  Poland; Not yet recruiting
      Warszawa,  04 749,  Poland; Not yet recruiting
      Szczecin,  70-111,  Poland; Not yet recruiting
Portugal
      Lisboa,  1069 050,  Portugal; Not yet recruiting
      Lisboa,  1249 075,  Portugal; Not yet recruiting
      Lisboa,  1349 019,  Portugal; Not yet recruiting
      Amadora,  2700 276,  Portugal; Not yet recruiting
      Almada,  2800 547,  Portugal; Not yet recruiting
      Coimbra,  3000 075,  Portugal; Not yet recruiting
      Porto,  4099 005,  Portugal; Not yet recruiting
Russian Federation
      Moscow,  105425,  Russian Federation; Recruiting
      Moscow,  111123,  Russian Federation; Recruiting
      Moscow,  117454,  Russian Federation; Not yet recruiting
      Moscow,  119881,  Russian Federation; Recruiting
      St Petersburg,  197089,  Russian Federation; Recruiting
      St Petersburg,  198013,  Russian Federation; Recruiting
Slovakia
      Martin,  3601,  Slovakia; Recruiting
      Bratislava,  83305,  Slovakia; Recruiting
Slovenia
      LJUBLJANA,  1525,  Slovenia; Recruiting
      MARIBOR,  2000,  Slovenia; Not yet recruiting
      Slovenj Gradec,  2380,  Slovenia; Not yet recruiting
South Africa
      Pretoria,  20100,  South Africa; Recruiting
      Johannesburg,  2193,  South Africa; Recruiting
      Durban,  4001,  South Africa; Recruiting
      Cape Town,  7505,  South Africa; Not yet recruiting
      Pretoria,  83,  South Africa; Recruiting
Spain
      A Coruna,  15006,  Spain; Not yet recruiting
      Madrid,  28006,  Spain; Not yet recruiting
      Madrid,  28007,  Spain; Recruiting
      Madrid,  28046,  Spain; Recruiting
      Malaga,  29009,  Spain; Not yet recruiting
      Alicante,  3550,  Spain; Not yet recruiting
      Vigo,  36204,  Spain; Not yet recruiting
      Sevilla,  41013,  Spain; Not yet recruiting
      Sevilla,  41018,  Spain; Not yet recruiting
      Valencia,  46009,  Spain; Not yet recruiting
      Valencia,  46009,  Spain; Not yet recruiting
      Valladolid,  47010,  Spain; Not yet recruiting
      Galdakao,  48960,  Spain; Recruiting
      Barcelona,  8035,  Spain; Not yet recruiting
      Barcelona,  8907,  Spain; Not yet recruiting
Sweden
      Stockholm,  118 83,  Sweden; Recruiting
      GOTHENBURG,  412 59,  Sweden; Recruiting
Switzerland
      Lausanne,  1011,  Switzerland; Not yet recruiting
      Biel,  2500,  Switzerland; Recruiting
      AARAU,  5001,  Switzerland; Not yet recruiting
United Kingdom
      Avon,  BS10 5NB,  United Kingdom; Not yet recruiting
      Edinburgh,  EH4 2XU,  United Kingdom; Not yet recruiting
      Leeds,  LS9 7TF,  United Kingdom; Not yet recruiting
      Newcastle upon Tyne,  NE7 7PN,  United Kingdom; Not yet recruiting
      Oldham,  OL1 2JH,  United Kingdom; Not yet recruiting
      Plymouth,  PL6 8DG,  United Kingdom; Not yet recruiting
      West Sussex,  PO19 4SE,  United Kingdom; Recruiting
      Sheffield,  S10 2JF,  United Kingdom; Recruiting
      Hampshire,  SG2 4AB,  United Kingdom; Not yet recruiting
      Stockport,  SK2 7JE,  United Kingdom; Not yet recruiting
      London,  SW17 0QT,  United Kingdom; Recruiting
      Somerset,  TA1 5DA,  United Kingdom; Recruiting

Study ID Numbers:  ARI40006
Record last reviewed:  September 2004
Record first received:  March 11, 2003
ClinicalTrials.gov Identifier:  NCT00056407
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-10-22