NCT01259297

A Randomized Controlled Trial of Aliskiren in the Prevention of Major Cardiovascular Events in Elderly People

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,336 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

This study was planned to provide new information regarding the role of aliskiren (with or without additional therapy with a diuretic or a Calcium channel blockers (CCB)) in elderly individuals (≥ 65 years) with systolic blood pressure (SBP) 130 to 159 mmHg, in preventing major cardiovascular (CV) events and on global measures of physical, executive and cognitive function.

Detailed description

This was 2x2 factorial design study with 2 strata. As per protocol, the first co- Primary analysis as well as secondary analysis were aliskiren based regimen vs non-aliskiren based regimen. All aliskiren based arm were combined into the aliskiren based regimen and all non-aliskiren based arms were combined into non-aliskiren based regimen.

Conditions

• Cardiovascular Events

Interventions

Type	Name	Description
DRUG	Aliskiren	Aliskiren 150/300 mg once daily
DRUG	Amlodipine	Amlodipine 5 mg
DRUG	Hydrochlorothiazide (HCTZ)	HCTZ 12.5/25 mg
DRUG	Placebo for Aliskiren	Placebo for Aliskiren 300 mg
DRUG	Placebo for Amlodipine	Placebo for Amlodipine
DRUG	Placebo for Hydrochlorothiazide (HCTZ)	Placebo for HCTZ 12.5/25 mg

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2010-12-14
• Last updated: 2014-04-08
• Results posted: 2014-04-08

Locations

185 sites across 18 countries: United States, Argentina, Brazil, Canada, Chile, Colombia, Czechia, Germany, Hungary, India, Ireland, Israel, Malaysia, Netherlands, Philippines, South Africa, Spain, Sweden