Abstract
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.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
References
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
Schwartz GG, et al. Rationale and design of the dal-OUTCOMES trial: efficacy and safety of dalcetrapib in patients with recent acute coronary syndrome. American Heart Journal 2009 Dec; 158 (6): 896–901
Roche. Roche provides update on phase III study of dalcetrapib. Media release, 7 May 2012. Available from: http://www.roche.com
Barter P, et al. HDL cholesterol, very low levels of LDL cholesterol, and cardiovascular events. New England Journal of Medicine 2007 Sep 27; 357 (13): 1301–10
Gordon DJ, et al. High-density lipoprotein cholesterol and cardiovascular disease: four prospective American studies. Circulation 1989 Jan; 79 (1): 8–15
Shah PK. Inhibition of CETP as a novel therapeutic strategy for reducing the risk of atherosclerotic disease. European Heart Journal 2007; 28: 5–12
Barter PJ, et al. Effects of torcetrapib in patients at high risk for coronary events. New England Journal of Medicine 2007 Nov 22; 357 (21): 2109–22
Rader DJ. Illuminating HDL — is it still a viable therapeutic target? New England Journal of Medicine 2007 Nov 22; 357 (21): 2180–3
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 Feb
Fayad ZA, et al. Safety and Efficacy of dalcetrapib on atherosclerotic disease using novel non-invasive multimodality imaging (dal-PLAQUE): a randomised clinical trial. Lancet 2011 Oct 29; 378 (9802): 1547–59
Adis R&D Insight database. Accessed 25 May 2012
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
Cannon CP, et al. Safety of ancetrapib in patients with or at high risk for coronary heart disease. New England Journal of Medicine 2010 Dec 16; 363: 2406–15
Nicholls SJ, et al. Effects of the CETP inhibitor evacetrapib administered as monotherapy or in combination with statins on HDL and LDL cholesterol: a randomized controlled trial. Journal of the American Medical Association 2011 Nov 16; 306 (19): 2099–109
Author information
Authors and Affiliations
Rights and permissions
About this article
Cite this article
Sweetlove, M. Phase III Trial of Dalcetrapib. Pharm Med 26, 253–256 (2012). https://doi.org/10.1007/BF03262483
Published:
Issue Date:
DOI: https://doi.org/10.1007/BF03262483