Effects of Valsartan and Aliskiren on Hemostatic Indices in Hypertensive Diabetics

Objectives: There are 2 objectives in the index study. • The primary objective is to determine how therapy with valsartan (160mg/daily) in combination with aliskiren (150-300mg/daily) over four weeks affects platelet/coagulation/fibrinolytic biomarkers in recently diagnosed hypertensive patients with type 2 diabetes mellitus. However, this is an exploratory study, our current knowledge is based on in vitro and ex vivo evidence for valsartan, but only on in vitro aliskiren data. There are no data on antithrombotic biomarkers currently available for the combination therapy. The secondary objective is: • To define whether combination therapy is superior over monotherapy with aliskiren with regard to the improvement of hemostatic biomarkers (platelet aggregation, expression of GP IIb/IIIa, and plasma levels of antithrombin-III). Study Design: This is a randomized 1:1, two arm, single-blind, single-site, parallel group, post-marketing comparison study of the effects on antithrombotic biomarkers of aliskiren 150-300mg/day alone vs combined treatment with aliskiren 150-300mg/day plus valsartan 160mg/day over a four week primary treatment period. An optional four week extension phase may be offered pending assessment of the antithrombotic biomarker assays at week four. Population: Two groups (25 patients each), for a total of 50, recently diagnosed hypertensive patients with previously diagnosed mild to moderate type 2 diabetes will constitute the proposed study population. The diagnosis of diabetes will be made based on the American Diabetes Association criteria, such as random plasma glucose \>200 mg/dL with or without symptoms of hyperglycemia (polydipsia, polyuria, polyphagia) and weight loss, or fasting plasma glucose \> 126 mg/dL, to be determined at least twice. Patients will qualify if they are insulin-free, treated with an oral antiglycemic agent,(metformin only) and/or managed on diet alone for no less than 30 days and have adequate glucose control at the time of their Screening Visit.