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An Assessment of Long Term Safety of the Combination of Aliskiren / Amlodipine in Patients With High Blood Pressure

NCT00402103 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 556

Last updated 2011-03-10

Study results available
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Summary

To assess the long-term (6 month and 12 month) safety of the combination of aliskiren 300 mg / amlodipine 10 mg in patients with essential hypertension (Mean Sitting Diastolic Blood Pressure \[msDBP\] ≥ 90 mmHg and \< 110 mmHg).

Conditions

Interventions

DRUG

Aliskiren

All patients received aliskiren 150 mg for the first two weeks; dose was then force-titrated to aliskiren 300 mg for 52 weeks duration

DRUG

Amlodipine

All patients received amlodipine 5 mg for the first two weeks; dose was then force-titrated to amlodipine 10 mg for 52 weeks duration

DRUG

Hydrochlorothiazide

Optional addition of Hydrochlorothiazide (HCTZ)of 12.5 mg with increase to 25 mg was allowed for patients not adequately controlled.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • United States
  • Belgium
  • Denmark
  • Finland
  • Germany
  • Iceland
  • India
  • Switzerland

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 NCT00402103 on ClinicalTrials.gov