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A Study Evaluating the Gastrointestinal (GI) Safety and Tolerability of Aliskiren Compared to Ramipril in Essential Hypertension

NCT00631917 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 774

Last updated 2011-07-12

Study results available
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Summary

This study will evaluate the long-term gastrointestinal (GI) safety and efficacy of aliskiren (300 mg) compared to ramipril (10mg) in patients ≥ 50 years with essential hypertension.

Conditions

Interventions

DRUG

Aliskiren

Aliskiren 300 mg once a day

DRUG

Ramipril

Ramipril 10 mg once a day

OTHER

Placebo to Ramipril

Placebo capsules to match ramipril.

OTHER

Placebo to Aliskiren

Placebo tablets to match aliskiren.

Sponsors & Collaborators

Principal Investigators

  • Novartis · 862-778-8300

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • United States
  • Argentina
  • Colombia
  • France
  • Germany
  • India
  • Spain

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 NCT00631917 on ClinicalTrials.gov