Extended Release (ER) Niacin/Laropiprant Add on Study (0524A-082)
Phase 3
Withdrawn
- Conditions
- Dyslipidemia
- Interventions
- Drug: placebo (unspecified)Drug: niacin (+) laropiprant
- Registration Number
- NCT00664287
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The purpose of this study is to test the effect of MK0524A (niacin (+) laropiprant) on lowering bad cholesterol and raising good cholesterol.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Patients 18 years of age or older and on a stable dose of lipid therapy
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Exclusion Criteria
- Patients lipid level is outside the recommended range
- Patients that are HIV positive
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 2 placebo (unspecified) Patients will remain on existing lipid-modifying therapy throughout the study. Group 2: Patients will receive 1 placebo tablet daily. After 4 weeks, patients will be advanced to 2 placebo tablets for remainder of the study. Group 1 niacin (+) laropiprant Patients will remain on existing lipid-modifying therapy throughout the study. Group 1: Patients will receive ER niacin/laropiprant 1 g/20 mg daily. After 4 weeks, ER niacin/laropiprant will be increased to 2 g/40 mg for remainder of study.
- Primary Outcome Measures
Name Time Method Lipid modification results of MK0524A (niacin (+) laropiprant) compared to placebo on LDL-C throughout the study and at 17 weeks. 3 months
- Secondary Outcome Measures
Name Time Method Lipid modification results of MK0524A (niacin (+) laropiprant) on blood lipids such as LDL-C, HDL-C, triglycerides, etc., throughout the study and at 17 weeks. 3 months