NCT00353522

A Phase II, Double-Blind, Randomized, Placebo-controlled, Parallel Group Study, Evaluating the Efficacy and Safety of RO4607381 Over a 24-week Period in Patients With CHD or a CHD Risk Equivalent

Completed Phase 2 Results posted Last updated 24 January 2020

What this trial tests

Phase 2 trial testing Placebo in Coronary Heart Disease in 135 participants. Completed in 1 October 2008.

Timeline

1 July 2006

Primary endpoint
1 October 2008

1 October 2008

Quick facts

Lead sponsor	Hoffmann-La Roche
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	135
Start date	1 July 2006
Primary completion	1 October 2008
Estimated completion	1 October 2008
Sites	17 locations across United States, Germany

Drugs / interventions tested

• Placebo
• dalcetrapib — full drug profile →

Conditions studied

• Coronary Heart Disease — all drugs for Coronary Heart Disease →

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

Adults 18 to 75, any sex, with Coronary Heart Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Absolute Change From Baseline in HDL-C
  Time frame: Baseline and Week 24
• Percent Change From Baseline in HDL-C
  Time frame: Baseline and Week 24

Sponsor's own description

This 2 arm study will investigate the efficacy and safety of RO4607381 in patients with coronary heart disease, or CHD risk equivalent. After a pre-randomization phase of 5-12 weeks, patients will be randomized to receive either RO4607381 (900mg po) or placebo po daily for 24 weeks, with concomitant atorvastatin 10-80mg daily, and changes in cholesterol level and lipoprotein metabolism will be measured. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Safety and tolerability of dalcetrapib (RO4607381/JTT-705): results from a 48-week trial.
   Stein EA, Roth EM, Rhyne JM, Burgess T, et al · · 2010 · cited 76× · PMID 20097702 · DOI 10.1093/eurheartj/ehp601