Trials / Completed
CompletedNCT00080275
Evaluation of the Safety & Efficacy of a Combination of Niacin ER & Simvastatin in Patients With Dyslipidemia (OCEANS)
An Open-Label Evaluation of the Safety and Efficacy of a Combination of Niacin ER and Simvastatin in Patients With Dyslipidemia (OCEANS)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 600 (planned)
- Sponsor
- Kos Pharmaceuticals · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this 24 week 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 600 subjects with a similar medical condition will take part in this study.
Detailed description
Objectives: To evaluate the safety and efficacy of the combination product niacin ER and simvastatin (NS) in patients with primary type II dyslipidemia and to descriptively compare flushing rates between two Titration Schedules for NS.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Niacin Extended-Release and simvastatin Tablets |
Timeline
- Start date
- 2004-03-01
- First posted
- 2004-03-29
- Last updated
- 2006-11-01
Source: ClinicalTrials.gov record NCT00080275. Inclusion in this directory is not an endorsement.