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Study to Evaluate the Efficacy and Safety of Combination Aliskiren/Amlodipine in Patients Not Adequately Responding to Aliskiren Alone

NCT00777946 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 818

Last updated 2011-07-12

Study results available
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Summary

This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients not adequately controlled with aliskiren alone

Conditions

Interventions

DRUG

Aliskiren 300 mg

Aliskiren 300 mg tablet taken orally once a day with a glass of water.

DRUG

Aliskiren/Amlodipine 300/5 mg

Aliskiren/Amlodipine 300/5 mg tablet taken orally once a day with a glass of water.

DRUG

Aliskiren/Amlodipine 300/10 mg

Aliskiren/Amlodipine 300/10 mg taken orally once a day with a glass of water.

DRUG

Placebo to Aliskiren

Placebo to Aliskiren tablet taken orally once a day.

DRUG

Placebo to Aliskiren/Amlodipine

Placebo to Aliskiren/Amlodipine taken orally once a day.

Sponsors & Collaborators

Principal Investigators

  • Novartis · Novartis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • Estonia
  • France
  • Iceland
  • India
  • Italy
  • Lithuania
  • South Korea
  • Spain
  • Venezuela

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 NCT00777946 on ClinicalTrials.gov