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Aliskiren and the Calcium Channel Blocker Amlodipine Combination as an Initial Treatment Strategy for Hypertension

NCT00797862 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1254

Last updated 2011-10-17

Study results available
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Summary

This study will compare the safety and efficacy of initial combination treatment with aliskiren + amlodipine to sequential add-on treatment strategies with aliskiren or amlodipine in patients with hypertension.

Conditions

Interventions

DRUG

Amlodipine

Amlodipine (5 mg and 10 mg) was provided as capsules taken orally once daily.

DRUG

hydrochlorothiazide

Hydrochlorothiazide 12.5 mg capsules were taken orally once daily

DRUG

Aliskiren

Aliskiren 150 mg and aliskiren 300 mg were provided as film-coated tablets, taken orally once daily.

Sponsors & Collaborators

Principal Investigators

  • Novartis · Novartis

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • Canada
  • Costa Rica
  • France
  • Germany
  • Greece
  • Guatemala
  • South Africa
  • Switzerland
  • United Kingdom
  • Venezuela

Study Locations

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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 NCT00797862 on ClinicalTrials.gov