A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Determine Whether, in Patients With Type 2 Diabetes at High Risk for Cardiovascular and Renal Events, Aliskiren, on Top of Conventional Treatment, Reduces Cardiovascular and Renal Morbidity and Mortality
A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Determine Whether, in Patients With Type 2 Diabetes at High Risk for Cardiovascular and Renal Events, Aliskiren, on Top of Conventional Treatment, Reduces Cardiovascular and Renal Morbidity and Mortality
The purpose of this study was to determine whether, in patients with type 2 diabetes and pre-existing disease of the heart and the circulatory system and/or the kidney, aliskiren at a target dose of 300 mg once daily (compared to placebo), on top of conventional treatment, reduces death and disease caused by the heart, the circulatory system and the kidney.
AMENDMENT 4 RATIONALE (MARCH 2012) :
Protocol amendment 4 served to address the data monitoring committee recommendation dated 14 Dec 2011 to discontinue study treatment in all participating patients. It also addressed the subsequent Health Authorities request to implement a 12 month safety follow-up period (actual duration was 9 months in average) post study drug discontinuation.
Inclusion Criteria:
Type 2 diabetes and at least one of the following:
Concomitant treatment should follow national guidelines and must include either an Angiotensin-converting-enzyme-inhibitor (ACEi) or an Angiotensin-receptor-blocker (ARB) but not both.
Exclusion Criteria:
EXCLUSION SPECIFIC TO THE SAFETY FOLLOW-UP PERIOD:
- Aliskiren or aliskiren containing fixed combination products must not be used
Other protocol-defined inclusion/exclusion criteria applied
Buenos Aires, Buenos Aires C1120AAC, Argentina
Buenos Aires, Buenos Aires C1405BCH, Argentina
Caba, Buenos Aires 1428, Argentina
Caba, Buenos Aires C1181ACH, Argentina
Caba, Buenos Aires C1280AEB, Argentina
Caba, Buenos Aires C1408INH, Argentina
Caba, Buenos Aires C1416DRJ, Argentina
Caba, Buenos Aires C1425AST, Argentina
Ste-Foy, Quebec G1V 4G2, Canada
Ouest-Montreal, H2W1R7, Canada
Prague 4 - Krc, 14059, Czechia
Prague 5 - Motol, 15112, Czechia
Copenhagen NV, Denmark DK-2400, Denmark
OYS, FIN-90029, Finland
Muehldorf Am Inn, 84453, Germany
Saint Ingbert - Oberwuerzbach, 66386, Germany
Schauenburg-Elgershausen, 34270, Germany
Athens - GR, 10676, Greece
Piraeurs, GR 184 54, Greece
Hyderabad, Andhra Pradesh 500001, India
Hyderabad, Andhra Pradesh 500012, India
Hyderabad, Andhra Pradesh 500018, India
Banglaore, Karnataka 560038, India
Kolkota, 700020, India
Passirana Di Rho, MI 20017, Italy
Ohtsu-city, Shiga 520-2192, Japan
Bunkyo-ku, Tokyo 113-8655, Japan
Chuo-ku, Tokyo 103-0002, Japan
Banksa Bystrica, SK 97 517, Slovakia
Gauteng, South Africa
Bundang, Seongnam 463-707, South Korea
La Pobla Llarga, Catalonia 46670, Spain
Llança, Catalonia 17490, Spain
Santa Coloma de Gramanet, Catalonia 08923, Spain
Civdad Real, Madrid 13002, Spain
Murcia, Madrid 30007, Spain
Hospitalet de Llbregat, 08902, Spain
Yungkang, Tainan 710, Taiwan
Niaosong Township, 83301, Taiwan
Taichung County, Taiwan
Cornwall, England PL23 1DT, United Kingdom
Lancashire, FY3 7EN, United Kingdom
Lancashire, FY4 3AD, United Kingdom
Merseyside, L7 8PX, United Kingdom
Vale of Glanmorgan, CF63 4AR, United Kingdom
Caracas, Miranda 1060, Venezuela