MedTrace Logo

A Safety and Tolerability Study of the Combination of Aliskiren/Valsartan in Patients With High Blood Pressure, Followed by Long-term Safety and Tolerability of Aliskiren, Valsartan and Hydrochlorothiazide.

NCT00386607 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 601

Last updated 2014-02-10

Study results available
· View outcomes & findings →

Summary

Assessment of the long-term safety and tolerability of the combination of aliskiren and valsartan (300 mg/ 320 mg) in patients with high blood pressure,followed by assessment of long-term safety and tolerability of the combination of aliskiren/valsartan/Hydrochlorothiazide(HCTZ).

Conditions

Interventions

DRUG

Aliskiren

Aliskiren 300 mg

DRUG

Valsartan

Valsartan 320 mg

DRUG

Hydrochlorothiazide (HCTZ)

Hydrochlorothiazide (HCTZ) 12.5-25 mg

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

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
2006-10-31
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • United States
  • Canada
  • Germany
  • Netherlands

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 NCT00386607 on ClinicalTrials.gov