ALTITUDE
8.600 patients, 831 sites, ongoing
The primary objective of the ALTITUDE trial is to determine whether aliskiren 300 mg once daily, reduces cardiovascular and renal morbidity and mortality compared to placebo, when added to conventional treatment (including ACEi or ARB).
ALTITUDE is an phase III, international, randomised, double-blind, placebo-controlled, parallel-group study, which includes three categories of high-risk patients with type 2 diabetes (age ≥35 years). This event driven trial aims to randomise 8.600 patients with a planned follow-up time of 48 months. In this trial, AACT Australia is responsible for China and India. The Julius Center and Julius Clinical Research are responsible for 800 patients in 43 sites in three European countries (Slovakia, Czech Republic and Hungary), of which 560 patients are currently randomised.
Publications:
Parving HH, Brenner BM, McMurray JJV, de Zeeuw D, Haffner SM, Solomon SD, Chaturvedi N, Ghadanfar M, Weissbach N, Xiang Z, Armbrecht J, Pfeffer MA. Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE): rationale and study design. Nephrol Dial Transplant. 2009; 24(5),1663-71.