Trials / Completed
CompletedNCT00479388
Study of Extended Release Niacin/Laropiprant on Lipids (0524A-067)
A Multicenter, Randomized, Double-Blind, Parallel Group, 12 Week Study to Evaluate the Efficacy and Safety of Extended-release (ER) Niacin/Laropiprant in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,216 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This is a 12-Week clinical trial in patients with Primary hypercholesterolemia or mixed dyslipidemia to study the effects of ER niacin/laropiprant on lipids.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Comparator: simvastatin | simvastatin (20mg to 40mg) for 12 weeks. |
| DRUG | niacin (+) laropiprant | One tablet of ER niacin/ laropiprant (1g); titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose. |
| DRUG | Comparator: atorvastatin calcium | atorvastatin calcium (20mg to 40mg) for 12 weeks. |
Timeline
- Start date
- 2007-07-01
- Primary completion
- 2008-07-01
- Completion
- 2008-10-01
- First posted
- 2007-05-28
- Last updated
- 2015-03-10
- Results posted
- 2009-07-31
Source: ClinicalTrials.gov record NCT00479388. Inclusion in this directory is not an endorsement.