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Study to Evaluate the Efficacy and Safety of Aliskiren Alone and in Combination With Amlodipine in Essential Hypertension

NCT00739973 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2694

Last updated 2011-06-06

Study results available
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Summary

Evaluate the efficacy (blood pressure lowering effect) and safety of aliskiren alone and in combination with amlodipine in patients with essential hypertension.

Conditions

Interventions

DRUG

Placebo

DRUG

Aliskiren 150 mg tablet

DRUG

Aliskiren 300 mg tablet

DRUG

Amlodipine 5 mg capsule

DRUG

Amlodipine 10 mg capsule

DRUG

Aliskiren/amlodipine 150/5 mg tablet

DRUG

Aliskiren/amlodipine 150/10 mg tablet

DRUG

Aliskiren/amlodipine 300/5 mg tablet

DRUG

Aliskiren/amlodipine 300/10 mg tablet

Sponsors & Collaborators

Principal Investigators

  • Novartis · Novartis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • United States
  • Argentina
  • Australia
  • Canada
  • Colombia
  • Denmark
  • Finland
  • Greece
  • Italy
  • Mexico
  • Panama
  • Peru
  • Romania
  • Russia
  • South Africa
  • Spain
  • Sweden
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
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 NCT00739973 on ClinicalTrials.gov