Trials / Completed
CompletedNCT00753779
A Study to Determine the Effect of WelChol Tablets on Cholesterol in Patients Who Have Been Taking Simvastatin for at Least 4 Weeks.
Efficacy of WelChol® as an Add-on to Simvastatin Therapy
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 72 (actual)
- Sponsor
- Daiichi Sankyo · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective is to determine the effect of WelChol tablets on serum lipids, lipoproteins, apolipoproteins, and lipoprotein particle size in patients who were stabilized on simvastatin therapy for at least 4 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | colesevelam HCl tablets, and simvastatin tablets | colesevelam HCl tablets, 6/day simvastatin tablet, 1/day |
| DRUG | simvastatin tablets and colesevelam HCl placebo | simvastatin tablet, 1/day; Welchol placebo tablets, 6/day |
Timeline
- Start date
- 2002-11-01
- Primary completion
- 2003-06-01
- Completion
- 2005-04-01
- First posted
- 2008-09-17
- Last updated
- 2015-04-03
Locations
14 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00753779. Inclusion in this directory is not an endorsement.