ALTITUDE

CV and Renal events in Diabetes (type 2) patients

A phase III, international, randomized, double-blind, placebo-controlled, parallel-group study, which included three categories of high-risk patients with type 2 diabetes (age ≥35 years).

Therapeutic areas

Total patients

8600

Total sites

45

Status

Finished

This study included 8,600+ patients from 36 countries and evaluated the potential benefits of a study medication to reduce the risk of cardiovascular and renal events in patients with type 2 diabetes. These patients are known to be at high risk of cardiovascular and renal events.

The primary objective of the trial was to determine whether this medication reduces cardiovascular and renal morbidity and mortality compared to a placebo, when added to conventional treatment (including ACEi or ARB). This event-driven trial randomized patients with a follow-up time of 48 months. Julius Clinical coordinated the site management for all European sites within this. 

Publications

Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE): rationale and study design

Hans-Henrik Parving, Barry M. Brenner, John. J. V. McMurray, Dick de Zeeuw, Steven M. Haffner, Scott D. Solomon, Nish Chaturvedi, Mathieu Ghadanfar, Nicole Weissbach, Zhihua Xiang, Juergen Armbrecht and Marc A. Pfeffer.

Nephrol Dial Transplant (2009) 24: 1663–1671

show details

Cardiorenal End Points in a Trial of Aliskiren for Type 2 Diabetes

Hans-Henrik Parving,Barry M. Brenner, John J.V. McMurray, Dick de Zeeuw, Steven M. Haffner, Scott D. Solomon, Nish Chaturvedi, Frederik Persson, Akshay S. Desai, Maria Nicolaides, Alexia Richard, Zhihua Xiang, Patrick Brunel Marc A. Pfeffer, for the ALTITUDE Investigators

N Engl J Med 2012;367:2204-13.

show details

A prediction of the renal and cardiovascular efficacy of aliskiren in ALTITUDE using short-term changes

PA Smink, J Hoekman, DE Grobbee, MJC Eijkemans, H-H Parving, F Persson, H Ibsen, L Lindholm, K Wachtell, D de Zeeuw and HJ Lambers Heerspink.

European Journal of Preventive Cardiology 2014 21: 434 

show details