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 (ALTITUDE)

NCT00549757 Phase 3 TERMINATED Results posted

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.

Details

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 3
Status	TERMINATED
Enrolment	8606
Start date	2007-10
Completion	2013-02

Conditions

• Type 2 Diabetes Mellitus
• Cardiovascular Disease

Interventions

• Aliskiren
• Placebo

Primary outcomes

• Percentage of Participants With Occurrence of Primary Composite Endpoint (Core : Active Treatment Phase) — Time from randomization to the first event (Maximum 50 months)
  Occurrence was defined as the first event of the following composite primary endpoint: * Cardiovascular (CV) death * Resuscitated sudden death * Non-fatal myocardial infarction (MI) * Non-fatal stroke * Unplanned hospitalization for heart failure (HF) * Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month. * Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL.
• Percentage of Participants With Cardiovascular (CV) Death (Core: Active Treatment Phase) — Time from randomization to the first event (Maximum 50 months)
• Percentage of Participants With Resuscitated Sudden Death (Core: Active Treatment Phase) — Time from randomization to the first event (Maximum 50 Months)
  Resuscitated sudden death was adjudicated when a subject experiences sudden death or cardiac arrest and is successfully resuscitated by cardioversion, defibrillation or cardiopulmonary resuscitation with a meaningful recovery of consciousness. This definition excludes known transient losses of consciousness such as seizure or vasovagal episodes that do not reflect significant cardiac dysfunction.
• Percentage of Participants With Fatal/Non-fatal Myocardial Infarction (MI) (Core: Active Treatment Phase) — Time from randomization to the first event (Maximum 50 Months)
• Percentage of Participants With Fatal/Non-fatal Stroke (Core: Active Treatment Phase) — Time from randomization to the first event (Maximum 50 Months)
• Percentage of Participants With Onset of End-stage Renal Disease (ESRD) (Core: Active Treatment Phase) — Time from randomization to the first event (Maximum 50 Months)
  ESRD is defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 µmol per liter) or renal death

Countries

United States, Argentina, Austria, Belgium, Brazil, Canada, China, Colombia, Czechia, Denmark, Finland, France, Germany, Greece, Guatemala, Hungary, India, Italy, Japan, Lithuania, Netherlands, Norway, Peru, Portugal, Puerto Rico, Singapore, Slovakia, South Africa, South Korea, Spain