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WelChol as Add-on to Simvastatin
NCT00753779Phase 4
Key facts
- Status
- Completed
- Start
- Nov 2002
- Primary completion
- Jun 2003
- Countries
- 1
- Sponsor
- Daiichi Sankyo Co., Ltd.
- Modality
- Polymer-based Nanoparticles, Small Molecules
- Drugs
- colesevelam
- Conditions
- hypercholesterolemia
01
Overview
Phase 4, randomised, double-blind trial in hypercholesterolemia comparing WelChol + Simvastatin with Placebo + Simvastatin (2 arms). Primary endpoint: Percent Change in LDL-C from Baseline at 6 weeks. Started Nov 2002; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
WelChol + Simvastatin
Colesevelam HCl tablets + Simvastatin tablets
Placebo + Simvastatin
Placebo tablets + Simvastatin tablets
03
Who it enrols
Adult patients with hypercholesterolemia stabilized on simvastatin for at least 4 weeks with LDL-C between 115-250 mg/dL and TG < 300 mg/dL.
04
Endpoints
Primary
Percent Change in LDL-C from Baseline
Secondary
Absolute Change in LDL-C from Baseline
Absolute and Percent Change in Total Cholesterol
Absolute and Percent Change in Triglycerides
Absolute and Percent Change in HDL-C
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