Efficacy of Lapaquistat Acetate Alone or Combined With High-Dose Statin Therapy in Subjects With Hypercholesterolemia
NCT00249899 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 649
Last updated 2012-05-24
Summary
The purpose of this study is to evaluate lapaquistat acetate, once daily (QD), taken alone or with additional statin therapy on cholesterol levels in treating patients with elevated cholesterol.
Conditions
Interventions
- DRUG
-
Lapaquistat acetate and stable statin therapy
Lapaquistat acetate 100 mg, tablets, orally, once daily and stable statin therapy for up to 24 weeks.
- DRUG
-
Stable statin therapy
Lapaquistat acetate placebo-matching, tablets, orally, once daily and stable statin therapy 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
- 2005-11-30
- Primary Completion
- 2007-03-31
- Completion
- 2007-03-31
Countries
- United States
- Canada
- South Africa
Study Locations
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