Type 2 Diabetes Mellitus Clinical Trial
Official title:
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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