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Comparative Efficacy Evaluation of Lipids when Treated with Niaspan & Statin or Other Lipid-Modifying Therapies-COMPELL
This study is currently recruiting patients.
| Sponsored by: | Kos Pharmaceuticals |
|---|---|
| Information provided by: | Kos Pharmaceuticals |
Purpose
The purpose of this study is to evaluate the effectiveness of first-line treatment using Niaspan (an extended release version of niacin) and statins versus other drugs that lower lipid levels, in subjects with elevated fat levels in their blood (dyslipidemia). Statins are a class of medication that is often prescribed to patients who need to lower their cholesterol levels.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Dyslipidemia Coronary Heart Disease Atherosclerosis Stroke Diabetes |
Drug: Niacin Drug: Atorvastatin Drug: Simvastatin Drug: Ezetimibe Drug: Rosuvastatin |
Phase IV |
MedlinePlus related topics: Circulatory Disorders; Coronary Disease; Diabetes; Metabolic Disorders; Stroke
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title: Comparative Efficacy Evaluation of Lipid Levels when Treated with Niaspan and Statin or Other Lipid-Modifying Therapies
Expected Total Enrollment: 300
Study start: April 2004
Name of Drugs: Niaspan (niacin extended-release tablets), Lipitor® (atorvastatin), Zocor® (simvastatin), Zetia™ (ezetimibe), and Crestor® (rosuvastatin)
Study Treatment: Four open-label parallel treatment groups for 12 weeks of observation
Objective: To evaluate the relative efficacy of first-line therapy using the combination of Niaspan and atorvastatin versus the combination of simvastatin and ezetimibe versus rosuvastatin monotherapy versus the combination of Niaspan and rosuvastatin in patients with dyslipidemia.
Population:
Design: A Phase IV, 12-week, randomized, multi-center, open-label, four-arm, parallel-group study evaluating the efficacy of Niaspan and statin therapy versus other lipid-modifying therapies preceded by a four-week washout of any previous lipid-lowering therapy.
Sample Size: Approximately 300 patients will be randomized equally to the four treatment groups.
Multi-center: Approximately 35 sites will participate.
Primary Endpoint: Mean percent change in LDL-C from Baseline to Week 12.
Secondary Endpoints: Mean percent change in high density lipoprotein cholesterol (HDL-C), TG, and non-high density lipoprotein cholesterol (non-HDL-C) from Baseline to Week 12.
Tertiary Endpoints: Lipid values including mean percent change in total cholesterol (TC) and the ratios of TC to HDL-C and LDL-C to HDL-C to Week 12. Safety variables such as serum transaminases, routine chemistry parameters, hematology, urinalysis, and adverse events will be evaluated as tertiary endpoints.
Adverse Events: Adverse events and flushing will be volunteered by patients and elicited by study staff.
Statistical Plan: All hypothesis tests will be two-sided and use a Type I error rate of 5%. The primary endpoint of mean percent change in LDL-C from Baseline to Week 12 will be evaluated using an ANOVA to assess differences across treatment groups. The secondary and tertiary endpoints will each be compared similarly across treatment groups in separate ANOVA models. If a statistically significant treatment group difference is found in an efficacy endpoint, relevant pairs of treatment groups will be compared using a procedure to control for Type I error in multiple comparisons. Adverse events will be tabulated by term and system organ class according to the MedDRA dictionary. Chi-square or Fisher’s Exact test will be used as appropriate to compare incidences between groups. Continuous-valued safety and efficacy variables will be summarized by treatment group and week using means (of observed and percent change values), the standard error of the mean, the median, the minimum, and the maximum. Discrete-valued safety and efficacy variables will be summarized by treatment group and week using frequencies and percents.
Eligibility
Ages Eligible for Study: 21 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
All of the following criteria must be answered “Yes”:
1. Patient is 21 years of age or older and willing to participate for the duration of the study;
2. Patient has read, signed, and agreed to the items listed in the informed consent form and HIPAA authorization form prior to the initiation of any study procedures and/or discontinuing any medications;
3. Patient is eligible for treatment following the drug washout period based upon the NCEP ATP III entry criteria and the LDL-C variability ≤ 15%;
4. Patient has mean triglyceride level (TG) ≤ 300 mg/dL;
5. Patient is willing to withdraw from any current anti-dyslipidemic medications or other prohibited medication for approximately 6 weeks prior to randomization (4 weeks prior to qualification visits) and for the duration of the study;
6. If the patient is female, the patient must not be pregnant or breast-feeding and not planning to become pregnant or to breast-feed for the duration of the study. Women of childbearing potential must commit to using a medically acceptable method of birth control such as oral contraception, intrauterine device (IUD), or a double-barrier method of contraception. Women using oral contraception must have done so for at least 3 months prior to randomization, and continue to do so for the duration of the study. To be considered not of childbearing potential, women must be post-menopausal for at least 2 years or surgically sterile.
Exclusion Criteria:
All the following criteria must be answered “No”:
1. Patient has an allergy, hypersensitivity, or intolerance to niacin, simvastatin, atorvastatin, ezetimibe, rosuvastatin or their derivatives;
2. Patient drinks more than 14 alcoholic drinks per week or has a previous history (within 12 months of screening) of substance abuse or dependency;
3. Patient has untreated or unsuccessfully treated psychiatric disease;
4. Patient has used an investigational study medication or participated in an investigational study within 30 days of obtaining qualification labs;
5. Patient has taken a prohibited medication within 4 weeks of obtaining qualification labs for the study (See section 8.0 - Concomitant Medications);
6. Patient has a history of any of the following:
7. Patient has any of the following abnormalities at any of the Screening or Qualification Visits:
8. Patient is planning to undergo major surgery within the next 6 months;
9. Patient has any health condition or laboratory abnormality that, in the opinion of the Principal Investigator, may be adversely affected by the procedures or medications in this study.
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