Novartis has announced details of two new long-term outcome studies in its ASPIRE Higher clinical trial program that has expanded to involve more than 35,000 patients in 14 trials.
The company said the newly launched studies will evaluate the organ protection potential of the first-in-class direct renin inhibitor Rasilez (known as Tekturna in the U.S.) for the treatment of heart failure and prevention of cardiovascular disease in the elderly, a patient segment that is predicted to more than double between 2000 and 2030. A third trial already under way is studying cardio-renal outcomes in patients with diabetes.
The ASPIRE Higher program includes a range of short- to medium-term studies to assess the potential organ protection benefits of Tekturna, across a range of cardio-renal conditions including heart failure, post-acute coronary syndromes, post-MI, left ventricular hypertrophy, coronary artery disease and diabetic nephropathy, according to the Basel, Switzerland-based Novartis. Other studies are designed to further confirm the blood pressure lowering effect of Tekturna.
“We look forward to the results of these additional long-term outcome studies that we hope will demonstrate the benefits of Tekturna independent of its powerful blood pressure reductions,” said Trevor Mundel, head of global development functions at Novartis Pharma.