Efficacy and Safety of the ACAT Inhibitor CS-505 (Pactimibe) for Reducing the Progression of Coronary Artery Disease

Phase 2 Completed 534 enrolled Daiichi Sankyo

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to learn if CS-505 is safe and effective for slowing down or possibly reversing the buildup of tissue, cells and fatty deposits (plaque) in the blood vessels of the heart (coronary artery atherosclerosis).

Timeline

Start: 2002-11
Primary completion: —
Completion: 2005-07

Outcome

Missed primary endpoint

paper The primary efficacy variable analyzing the progression of atherosclerosis--the change in percent atheroma volume--was similar PMID 16554527 ↗

paper treatment with an ACAT inhibitor did not improve the primary efficacy variable (percent atheroma volume) PMID 16554527 ↗

release “pactimibe did not meet the primary endpoint in the coronary intravascular ultrasound study (Study 505-202, ACTIVATE).” daiichisankyo.com ↗

Publications

Nissen SE, Tuzcu EM, Brewer HB, Sipahi I, Nicholls SJ, Ganz P, Schoenhagen P, Waters DD, Pepine CJ, Crowe TD, Davidson MH, Deanfield JE, Wisniewski LM, Hanyok JJ, Kassalow LM; ACAT Intravascular Atherosclerosis Treatment Evaluation (ACTIVATE) Investigators. Effect of ACAT inhibition on the progression of coronary atherosclerosis. N Engl J Med. 2006 Mar 23;354(12):1253-63. doi: 10.1056/NEJMoa054699.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pactimibe	Small molecule	100 mg	—