CV Therapeutics Inc. started a second pivotal study of its anti-anginal drug ranolazine in a trial that will combine the small molecule with beta blockers and calcium channel blockers.
The randomized, double-blind, placebo-controlled trial will test combination therapies in about 450 patients. It is expected to take about a year and a half.
The Palo Alto, Calif.-based company has treated the last patient in the first pivotal trial, which assessed ranolazine as a monotherapy against placebo in a crossover study. Data from that 152-patient study are expected to be released in the third quarter, said Christopher Chai, CV Therapeutics' director of strategic planning and investor relations.
The primary endpoint in both studies is treadmill times, or how long a patient can exercise vs. placebo.
Chai said the new trial will involve all patients taking either a calcium channel blocker or beta blocker, and then taking one of two doses of ranolazine or placebo. The study has been named CARISA, which stands for combination assessment of ranolazine in stable angina.
The first study is called MARISA - monotherapy assessment of ranolazine in stable angina.
CV Therapeutics in May put a plan into place for the marketing of the drug through a deal with Innovex Inc., a subsidiary of Quintiles Transnational Corp., of Research Triangle Park, N.C. Under that outsourcing arrangement CV Therapeutics retained all product rights. (See BioWorld Today, May 12, 1999, p. 1.)
CV Therapeutics' stock (NASDAQ:CVTX) gained 6.25 cents Wednesday to close at $5.562. - Jim Shrine