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A Double-Blind, Randomized, Parallel Group Study to Evaluate the Safety, Tolerability and Efficacy of Lapaquistat Acetate Alone or Coadministered With Atorvastatin in Subjects With Primary Dyslipidemia
The purpose of this study is to evaluate the overall safety of Lapaquistat Acetate, once daily (QD), by itself or in combination with atorvastatin in subjects with primary dyslipidemia.
Details
| Lead sponsor | Takeda |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 2130 |
| Start date | 2004-11 |
| Completion | 2007-05 |
Conditions
- Dyslipidemia
Interventions
- Lapaquistat acetate
- Lapaquistat acetate and atorvastatin
- Atorvastatin
Primary outcomes
- Lens Opacity Classification System findings — Weeks 24, 48, 72, and 96 or Final Visit
- Best corrected visual acuity — Weeks 24, 48, 72, and 96 or Final Visit
- Adverse Events — Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 or Final Visit
- Clinical Laboratory Tests — Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 or Final Visit
- Vital signs (blood pressure and pulse rate) and weight — Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 or Final Visit
- 12-lead Electrocardiogram — Weeks 48 and 96 or Final Visit
Countries
United States, Argentina, Chile, Czechia, Estonia, Germany, Hungary, Latvia, Lithuania, Mexico, Netherlands, Peru, Poland, Russia, Slovakia, South Africa, United Kingdom