(dailyRx News) Drugmaker Roche has halted a pivotal late-stage clinical trial for an experimental medication designed to increase "good" HDL cholesterol after the study revealed it did not offer a benefit.
The independent Data and Safety Monitoring Board recommended that the phase III trial of cholesterol drug dalcetrapib be terminated "due to a lack of clinically meaningful efficacy."
“Lowering cardiovascular risk beyond that which is achieved with intensive statin treatment is a very challenging goal and while we have always stated that dalcetrapib is a high-risk project, we are disappointed by the fact that this drug didn't provide benefit to the patients in our study,” said Hal Barron MD, chief medical officer and head of global product development for Roche.
Though the independent agency said the drug wasn't effective, it did not express safety concerns. However, Roche already has decided it will not pursue additional trials. Six trials were originally planned to evaluate dalcetrapib as part of the dal-HEART development program.
The dal-OUTCOMES trial was designed to test the safety and effectiveness of the medication in addition to the usual standard of care in patients with stable coronary heart disease following an acute coronary syndrome. In essence researchers hoped to determine whether increasing HDL cholesterol could aid heart patients. A pair of previous trials of dalcetrapib showed it did not increase blood pressure.
Additional trials of the experimental drug had been planned. Investigators planned to enroll 15,000 acute coronary syndrome patients to determine whether the drug could prevent heart attack and stroke. Roche also was recruiting for a 20,000-person trial to test the drug in patients at risk of heart disease who had never suffered a heart attack.