Efficacy of Lapaquistat Acetate Alone and With Ezetimibe in Subjects With Primary Dyslipidemia.
NCT00268697 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1267
Last updated 2012-05-24
Summary
The purpose of the study is to determine the efficacy of lapaquistat acetate, once daily (QD), taken with ezetimibe on cholesterol levels in subjects with primary dyslipidemia
Conditions
Interventions
- DRUG
-
Lapaquistat acetate
Lapaquistat acetate 100 mg, tablets, orally, once daily for up to 24 weeks.
- DRUG
-
Lapaquistat acetate and ezetimibe
Lapaquistat acetate 100 mg, tablets, orally, once daily and stable ezetimibe therapy for up to 24 weeks.
- DRUG
-
Ezetimibe
Lapaquistat acetate placebo-matching tablets, orally, once daily and stable ezetimibe 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
- 2005-10-31
- Primary Completion
- 2007-01-31
- Completion
- 2007-01-31
Countries
- Estonia
- Latvia
- Russia
- Serbia
Study Locations
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