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Evaluation of the Safety & Efficacy of a Combination of Niacin ER & Simvastatin in Patients with Dyslipidemia (OCEANS)
This study is currently recruiting patients.
| Sponsored by: | Kos Pharmaceuticals |
|---|---|
| Information provided by: | Kos Pharmaceuticals |
Purpose
The purpose of this study is to compare the effectiveness and safety of different doses of Niacin ER/Simvastatin (NS), in subjects with elevated fat levels in their blood (dyslipidemia).
At least 1000 subjects with a similar medical condition to yours will take part in this study, at sites within the United States.
Niacin and simvastatin are medications that have been individually approved to treat high cholesterol. Kos has developed an investigational formula combining both niacin and simvastatin, named in this study as NS, for the treatment of cholesterol and lipid disorders (high fat content in your blood). Different doses of NS (the study drug) will be evaluated, with tablets being made from different dosages of combined niacin extended release (ER) and simvastatin immediate release (IR). The use of NS to treat lipid disorders is considered investigational. An investigational use is one that is not approved by the U.S. Food and Drug Administration (FDA).
Please note: If you agree to participate in the study, you must stop taking your cholesterol lowering medications except Zocor®. In addition, prohibited medications that could interfere with the study drug will need to be discontinued for a minimum of 6 weeks before Qualification Visits and for the length of the study. Please discuss this with your study doctor.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Coronary Heart Disease Dyslipidemia Atherosclerosis Hypercholesterolemia Stroke |
Drug: Niacin Extended-Release and simvastatin Drug: Zocor (simvastatin) |
Phase III |
MedlinePlus related topics: Cholesterol; Circulatory Disorders; Coronary Disease; Metabolic Disorders; Stroke
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: An Open-Label Evaluation of the Safety and Efficacy of a Combination of Niacin ER and Simvastatin in Patients with Dyslipidemia (OCEANS)
Expected Total Enrollment: 1000
Study start: March 2004
Objectives: To evaluate the safety and efficacy of the combination product niacin ER and simvastatin (NS) as a second line therapy in patients with dyslipidemia and to compare flushing rates between two Titration Schedules for NS.
Population: Enrollment: Men and women, 21 years of age or older, with Type II hyperlipidemia (i.e., patient does not have hyperlipidemia caused by an uncontrolled, underlying disease state such as hypothyroidism).
Three distinct patient groups will be screened for this study. They include:
A. No Medication Group This group consists of patients who are not taking any lipid modifying medication at Screening who meet all Screening Entry Criteria but who do not satisfy the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) Low-Density Lipoprotein Cholesterol (LDL-C) goals. To be eligible for participation, patients either have been compliant with the Therapeutic Lifestyle Changes (TLC) diet for ≥ 6 weeks or will demonstrate compliance during participation in the Run-In Phase. During the Run-In Phase, patients will receive Zocor 40 mg daily. At the end of the Run-In Phase, patients will be evaluated for Lipid Qualification.
B. Zocor 40 mg Group This group consists of patients who have taken Zocor 40 mg daily for ≥ 6 weeks, however, do not satisfy LDL and/or non-HDL-C NCEP ATP III treatment goals at Screening (see Table 2, Section 4.1). If a patient has taken this medication regimen for ≥ 6 weeks, has been TLC diet compliant for at least 6 weeks prior to Screening, and has satisfied all other screening criteria, the Run-In Phase will be skipped and the patient will proceed directly to the Lipid Qualification Phase.
C. Other Medication Group This group consists of patients who are taking any lipid modifying medications other than Zocor 40 mg, including those patients taking Zocor doses less than 40 mg per day. Prior to entering the Run-In Phase, Screening Entry Criteria must be met, NCEP ATP III treatment goals for LDL-C and/or non-HDL-C must not be satisfied, and patients must discontinue all lipid modifying medication. During the Run-In Phase, patients will receive Zocor 40 mg daily and maintain TLC dietary compliance for 6 weeks. At the end of the Run-In Phase, patients will be evaluated for Lipid Qualification.
At Screening, patients who are taking Zocor doses greater than 40 mg daily will be ineligible for participation in the study.
Screening Entry Criteria include:
1) Mean triglycerides < 500 mg/dL;
2) Patients must fulfill criteria of one of the following groups:
No Medication, Zocor 40 mg, or Other Medication;
3) For patients in both the Zocor 40 mg and Other Medication Groups:
LDL C and/or non HDL C exceeds NCEP ATP III treatment goal;
4) For patients in the No Medication Group: LDL C exceeds NCEP ATP III level for which initiating drugtherapy is merited;
The following safety laboratory testing will occur at Qualification Visit 2:
1) ALT and AST ≤ 1.3 times upper limit of normal (ULN);
2) CPK ≤ 3 times ULN.
Design: This is a multi-center, Phase III, open-label, parallel group study, consisting of randomization into one of two Titration Schedules at the start of the Treatment Phase. After completing the assigned Titration Schedule A or B, all patients will receive NS 2000/40 for up to an additional 36 or 40 weeks, respectively. Early Termination may shorten the length of time in the open-label Treatment Phase.
Screening Phase: The Screening visit is required for study enrollment. Lipid and laboratory safety evaluations will be conducted as well as assessment for TLC dietary compliance.
Run-In Phase: This phase is not required for patients who have been taking Zocor 40mg daily and are TLC diet compliant for ≥ 6 weeks prior to Screening. All patients participating in this phase will receive Zocor 40 mg daily (after discontinuing other lipid modifying medication, if necessary) while following the TLC diet.
Lipid Qualification Phase: This phase is necessary to qualify for Randomization. Following the 6-week Run-In Phase, (or Screening for patients exempt from Run-In Phase) lipid panel evaluation will be done. Qualification Visits 1 and 2 (and Qualification 3, if necessary) will be obtained 7 ± 3 days apart. Patients meeting the following Lipid Qualification Criteria will be randomized to the Treatment Phase:
1. LDL-C demonstrates ≤ 15% variability. The LDL-C values of two consecutive blood samples drawn at Qualification 1 and Qualification 2 (Qualification 3, if necessary), taken 7 ± 3 days apart, must be within 15% of each other.
2. Based on the average LDL C and non-HDL C values at Qualification Visits 1 and 2 (or 2 and 3, if required), LDL C and/or non-HDL C does not meet NCEP ATP III treatment goals.
Randomization: Randomization occurs after patients have met Lipid Qualification and may be considered the initiation of the Treatment Phase. Patients will be randomized in a 1:1 fashion to either:
Titration Schedule A: 4 weeks on each escalating dose of NS 500/40, NS 1000/40, and NS 1500/40, followed by NS 2000/40 for 36 weeks.
Titration Schedule B: 4 weeks on each escalating dose of NS 500/40 and NS 1000/40, followed by NS 2000/40 for 40 weeks.
Treatment Phase: This phase is defined as the time period from Randomization to Week 48 or Early Termination.
Study medication will be taken once daily with a low-fat snack at bedtime.
Patients will be advised that one 325 mg non-enteric coated aspirin may be taken ½ hour prior to study medication to help prevent possible flushing effects commonly associated with niacin products. Patients already taking 325 mg non-enteric coated aspirin for prophylaxis (e.g., for heart disease) will be advised to take the aspirin ½ hour prior to taking study medication. The Site will notify the Sponsor regarding patients who are taking other aspirin formulations.
By Week 20, if the patient does not satisfy LDL C treatment goal, based on risk criteria, the patient will be withdrawn from the study.
Eligibility
Ages Eligible for Study: 21 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
In order to participate, all of the following criteria must be answered “Yes”:
Exclusion Criteria:
In order to participate, all the following criteria must be answered “No”:
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