Efficacy of Lapaquistat Acetate Alone or Combined With High-Dose Statin Therapy in Subjects With Hypercholesterolemia

Phase 3 Terminated 649 enrolled Takeda

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2005-11
Primary completion: 2007-03
Completion: 2007-03

Outcome

Outcome not reported

Stopped: “Overall profile of the compound does not offer significant clinical advantage to patients over currently available lipid lowering agents”

Publications

Results Stein EA, Bays H, O'Brien D, Pedicano J, Piper E, Spezzi A. Lapaquistat acetate: development of a squalene synthase inhibitor for the treatment of hypercholesterolemia. Circulation. 2011 May 10;123(18):1974-85. doi: 10.1161/CIRCULATIONAHA.110.975284. Epub 2011 Apr 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lapaquistat acetate	Small molecule	100 mg	Oral
Background	Atorvastatin	Small molecule	—	—
Background	Rosuvastatin	Small molecule	—	—
Background	Simvastatin	Small molecule	—	—