Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints (Core and Extension Phases)
Status:
Terminated
Trial end date:
2013-02-01
Target enrollment:
Participant gender:
Summary
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.