Phase III Trial of Dalcetrapib
A randomized, double-blind, placebo-controlled study assessing the effect of RO4607381 on cardiovascular mortality and morbidity in clinically stable patients with a recent acute coronary syndrome.
This trial was designed to investigate the efficacy and tolerability of dalcetrapib (RO4607381) in clinically stable patients with a recent acute coronary syndrome. The primary outcome was the time to first occurrence of the composite cardiovascular event (death due to coronary heart disease, major nonfatal coronary event or stroke).
The independent Data Safety Monitoring Board (DSMB) recommended discontinuation of the trial citing a lack of clinically meaningful efficacy, following the results of the second interim analysis. As a result of the recommendation, Roche decided to terminate the dal-OUTCOMES trial and three ongoing phase III dalcetrapib trials in the dal-HEART programme. Although the compound was not efficacious, no new safety signals were reported by the DSMB with regards to the dal-OUTCOMES trial.
KeywordsCholesteryl Ester Transfer Protein Rimonabant High Density Lipoprotein Cholesterol Level Torcetrapib High Density Lipoprotein Level
- 1.A Randomized, Double-blind, Placebo-controlled Study Assessing the Effect of RO4607381 on Cardiovascular Mortality and Morbidity in Clinically Stable Patients With a Recent Acute Coronary Syndrome. ClinicalTrials. gov, 25 May 2012. Available from: http://clinicaltrials.gov/ct2/show/NCT00658515
- 3.Roche. Roche provides update on phase III study of dalcetrapib. Media release, 7 May 2012. Available from: http://www.roche.com
- 9.Luscher TF, et al. Vascular effects and safety of dalcetrapib in patients with or at risk of coronary heart disease: the dal-VESSEL randomized clinical trial. European Heart Journal 2012 FebGoogle Scholar
- 11.Adis R&D Insight database. Accessed 25 May 2012Google Scholar
- 12.REVEAL: Randomized EValuation of the Effects of Anacetrapib Through Lipid-modification. A Large-scale, Randomized Placebo-controlled Trial of the Clinical Effects of Anacetrapib Among People With Established Vascular Disease. ClinicalTrials.gov, 25 May 2012. Available from: http://clinicaltrials.gov/ct2/show/NCT01252953