An Open-Label Extension Study to Evaluate the Safety and Tolerability of Lapaquistat Acetate in Subjects With Hypercholesterolemia

NCT00868127 Phase 3 COMPLETED

The purpose of this study is to determine the long-term safety of lapaquistat acetate, once daily (QD), as monotherapy or in combination with other lipid-lowering agents in Subjects with Hypercholesterolemia.

Details

Lead sponsor	Takeda
Phase	Phase 3
Status	COMPLETED
Enrolment	574
Start date	2005-12
Completion	2007-07

Conditions

• Hypercholesterolemia

Interventions

• Lapaquistat acetate
• Lapaquistat acetate and additional lipid-lowering therapy

Primary outcomes

• Adverse Events — Weeks 2, 4, 8, 12, 24, 36 and 48
• Vital Signs — Weeks 2, 4, 8, 12, 24, 36 and 48
• Clinical Laboratory Blood Sample for Lipid Panel — Weeks 2, 4, 8, 12, 24, 36 and 48
• Clinical Laboratory Serum Chemistries — Weeks 2, 4, 8, 12, 24, 36 and 48
• Clinical Laboratory Hematology — Weeks 2, 4, 8, 12, 24, 36 and 48
• Clinical Laboratory Serum Human Chorionic Gonadotropin — Weeks 2, 4, 8, 12, 24, 36 and 48