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Efficacy and Safety of Aliskiren Administered in Combination With Amlodipine Versus Amlodipine Alone in African American Patients With Stage 2 Hypertension

NCT00853957 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 443

Last updated 2012-04-30

Study results available
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Summary

The purpose of the study is to evaluate the BP-lowering efficacy of the combination of aliskiren and amlodipine, as initial therapy, compared to amlodipine monotherapy in African American patients with Stage II hypertension.

Conditions

Interventions

DRUG

Aliskiren/Amlodipine

Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg

DRUG

Amlodipine

Amlodipine 5 mg titrated to 10mg

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
2009-02-28
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • United States

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 NCT00853957 on ClinicalTrials.gov