Nitromed’s BiDil Combination Therapy for Congestive Heart Failure
November 8, 2004 by admin · Leave a Comment
On November 8, 2004 Nitromed reported that the data from its Phase 3 A-HeFT trial would be published in the New England Journal of Medicine and presented at the American Heart Association’s Late Breaking Scientific Sessions. This randomized, placebo-controlled, double blind clinical trial enlisted 1050 African American patients with New York Heart Association class III [...]
Eli Lilly and Sankyo’s CS-747 / Prasugrel for Acute Coronary Syndrome
October 25, 2004 by admin · Leave a Comment
On October 25, 2004 Eli Lilly and Company and Sankyo Company announced that a Phase 3 clinical trial comparing the antiplatelet agents prasugrel and Plavix™ is scheduled to begin later this year. The study, known as TRITON-TIMI 38, will include a reported 13,000 patients who are suffering acute coronary syndromes (heart attacks or unstable angina) [...]
Vytorin for the Treatment of Hyperlipidemia
May 14, 2004 by admin · Leave a Comment
Vytorin is a combination therapy comprised of two drugs already separately approved for the treatment of hyperlipidemia. Zocor (simvistatin) and Zetia (ezetimibe) are combined in this oral medication currently awaiting an FDA decision on approval. Results released by Merck and Schering-Plough in March 2004 from Phase III clinical trials demonstrated that patients taking Zocor and [...]
Cordis Carotid System for Carotid Artery Disease
On April 21, 2004 Cordis Corporation announced that the FDA’s Circulatory System Devices Panel had recommended approval of the Cordis Carotid System. Cordis’ pre-market approval application drew upon results of the SAPPHIRE Study, which included 334 high-risk surgical patients randomized to receive the stent with embolic protection vs. the traditional carotid endarterectomy. According to Cordis, [...]
CV Therapeutics’ Ranexa for Chronic Angina
April 20, 2004 by admin · Leave a Comment
On April 20, 2004 CV Therapeutics released data from its Monotherapy Assessment of Ranolazine In Stable Angina (MARISA) trial. The company reported that patients with chronic angina taking Ranexa™ (ranolazine) had a statistically significant increase in symptom-limited exercise duration at trough drug concentrations. The MARISA clinical trial is a double blind, placebo controlled study involving [...]