Gujarat : Ahmedabad based pharma major Cadila Pharmaceuticals Limited has received a prestigious Wellcome Trust Award under the new R&D for Affordable Healthcare in India initiative to support a phase III clinical trial of PolycapTM, a combination pill to reduce the risk of Cardiovascular diseases.

Cardio Vascular Diseases (CVD), predominantly heart disease and stroke, account for around 30% of all deaths around the world. The PolycapTM offers a primary prevention strategy to individuals who are at high risk for these illnesses.

PolycapTM comprises three blood pressure reducing agents, including a diuretic and a beta blocker, together with a cholesterol-lowering statin. All of the agents have been chosen based on the evidence of their reducing cardiovascular risk and generic drug status.

The combination pill has already been tested in over 2000 volunteers across 50 centers in India as part of The Indian PolycapTM Study (TIPS) published in the Lancet in 2009. Results from that phase II trial found that use of the drug reduces the risk of coronary heart disease by 62% and stroke by 48%.

Speaking of the award, Mr. Indravadan Modi, Chairman of Cadila Pharmaceuticals said, “We are delighted that our innovative product has gained recognition by the UK’s leading biomedical foundation, the Wellcome Trust. This award endorses our efforts in providing research-based revolutionary products in the cardio care segment.”

The Wellcome Trust award will support the study of at least 5,000 individuals with no previous history of heart attack or stroke. The placebo-controlled trial will recruit men over the age of 55 and women over 60 that have been identified as being at increased risk of CVD through a questionnaire based on family history and lifestyle factors. The investigators will assess whether taking PolycapTM for a period of five years can cut the risk of CVD, by monitoring the incidence of death due to heart attack, non-fatal heart attack, and non-fatal stroke.

Dr Nick Dunster, Senior Business Analyst at the Wellcome Trust, commented: “Cadila Pharmaceuticals has already reported positive results from previous clinical trials and we look forward to seeing how PolycapTM performs in this larger phase III trial. CVD is a global problem, so a drug that can cut the risk for susceptible individuals has the potential to make a huge impact on human health the world over, not just in India.”