Efficacy of Lapaquistat Acetate Alone or Combined With Rosuvastatin in Subjects With Hypercholesterolemia
NCT00249912 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 415
Last updated 2012-05-24
Summary
The purpose of this study is to evaluate lapaquistat acetate, once daily (QD), taken alone or with rosuvastatin on cholesterol levels in treating patients with elevated cholesterol.
Conditions
Interventions
- DRUG
-
Lapaquistat acetate and rosuvastatin
Lapaquistat acetate 50 mg, tablets, orally, once daily and stable Rosuvastatin therapy (10 or 20 mg) for up to 24 weeks.
- DRUG
-
Lapaquistat acetate and rosuvastatin
Lapaquistat acetate 100 mg, tablets, orally, once daily and stable Rosuvastatin therapy (10 or 20 mg) for up to 24 weeks.
- DRUG
-
Rosuvastatin
Lapaquistat acetate placebo-matching tablets, orally, once daily and stable Rosuvastatin therapy (10 or 20 mg) for up to 24 weeks.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Medical Director · Takeda
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-10-31
- Primary Completion
- 2007-04-30
- Completion
- 2007-04-30
Countries
- United States
- Canada
Study Locations
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