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

NCT01259297 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2336

Last updated 2014-04-08

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • Chile
  • Colombia
  • Czechia
  • Germany
  • Hungary
  • India
  • Ireland
  • Israel
  • Malaysia
  • Netherlands
  • Philippines
  • South Africa
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01259297 on ClinicalTrials.gov