NCT00655538

A Randomized, Placebo-controlled Study of the Safety, Tolerability and Effect on Endothelial Function, as Measured by Flow Mediated Dilatation, of RO4607381 in Patients With Coronary Heart Disease (CHD) or CHD Risk Equivalents.

Completed Phase 2 Results posted Last updated 13 December 2019

What this trial tests

Phase 2 trial testing Placebo in Coronary Heart Disease in 476 participants. Completed in 1 May 2010.

Timeline

1 February 2008

Primary endpoint
1 May 2010

1 May 2010

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	476
Start date	1 February 2008
Primary completion	1 May 2010
Estimated completion	1 May 2010
Sites	23 locations across Austria, France, Germany, Italy, Netherlands, Switzerland, United Kingdom

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.

• Change From Baseline in % Flow Mediated Dilatation (FMD)
  Time frame: Baseline and 12 weeks
• Change From Baseline in Mean BP, Measured by BP Monitoring
  Time frame: Baseline and 4 weeks

Sponsor's own description

This study will assess the safety, tolerability and efficacy of RO4607381 in patients with coronary heart disease (CHD) or CHD risk equivalents. Patients will be randomized to receive either RO4607381 600mg po daily or placebo po daily. Endothelial function will be measured by flow mediated dilatation and blood pressure monitoring will be assessed. The anticipated time on study treatment is up to 12 months, and the target sample size is up to 500 individuals.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Vascular effects and safety of dalcetrapib in patients with or at risk of coronary heart disease: the dal-VESSEL randomized clinical trial.
   Lüscher TF, Taddei S, Kaski JC, Jukema JW, et al · · 2012 · cited 165× · PMID 22345126 · DOI 10.1093/eurheartj/ehs019
2. Cholesteryl ester transfer protein inhibition as a strategy to reduce cardiovascular risk.
   Barter PJ, Rye KA. · · 2012 · cited 112× · PMID 22550134 · DOI 10.1194/jlr.r024075
3. A practical method for transforming free-text eligibility criteria into computable criteria.
   Tu SW, Peleg M, Carini S, Bobak M, et al · · 2011 · cited 80× · PMID 20851207 · DOI 10.1016/j.jbi.2010.09.007
4. Rationale and design of dal-VESSEL: a study to assess the safety and efficacy of dalcetrapib on endothelial function using brachial artery flow-mediated vasodilatation.
   Kastelein JJ, Duivenvoorden R, Deanfield J, de Groot E, et al · · 2011 · cited 23× · PMID 21128879 · DOI 10.1185/03007995.2010.536207
5. Utility of atherosclerosis imaging in the evaluation of high-density lipoprotein-raising therapies.
   Duivenvoorden R, Fayad ZA. · · 2011 · cited 7× · PMID 21465111 · DOI 10.1007/s11883-011-0176-1
6. Dalcetrapib: JTT 705; JTT-705; R 1658; R1658; RG1658; RO 4607381; RO4607381.
   · 2010 · cited 1× · PMID 20509713 · DOI 10.2165/11537720-000000000-00000