Efficacy of Lapaquistat Acetate in Subjects With Hypercholesterolemia
NCT00865228 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 224
Last updated 2012-05-24
Summary
The purpose of this study is to determine the role of time of dosing on the lipid-lowering effects of lapaquistat acetate, once daily (QD) or twice daily (BID), in subjects with hypercholesterolemia.
Conditions
Interventions
- DRUG
-
Lapaquistat acetate
Lapaquistat acetate 100 mg, tablets, orally, once daily in the morning and Lapaquistat acetate placebo-matching tablets, orally, once daily in the evening for up to six weeks.
- DRUG
-
Lapaquistat acetate
Lapaquistat acetate placebo-matching tablets, orally, once daily in the morning and Lapaquistat acetate 100 mg, tablets, orally, once daily in the evening for up to six weeks.
- DRUG
-
Lapaquistat acetate
Lapaquistat acetate 50 mg, tablets, orally, once daily in the morning and Lapaquistat acetate 50 mg, tablets, orally, once daily in the evening for up to six weeks.
- DRUG
-
Lapaquistat acetate placebo-matching tablets, orally, once daily in the morning and Lapaquistat acetate placebo-matching tablets, orally, once daily in the evening for up to six weeks.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
VP, Clinical Science · Takeda
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-07-31
- Primary Completion
- 2007-11-30
- Completion
- 2007-11-30
Countries
- United States
Study Locations
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