MedTrace Logo

Efficacy and Safety of Valsartan and Amlodipine (± HCTZ) in Adults With Moderate, Inadequately Controlled Hypertension

NCT00523744 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 257

Last updated 2020-08-04

Study results available
· View outcomes & findings →

Summary

This study will evaluate the efficacy and safety of valsartan and amlodipine in fixed dose combination in adults with moderate, inadequately controlled hypertension. There was an optional study extension for eligible patients who wanted to participate that contains the triple therapy (ie, hydrochlorothiazide+ amlodipine/valsartan).

Conditions

Interventions

DRUG

Amlodipine

Amlodipine supplied as 5 mg tablets, taken orally once a day during Treatment Phase 1 only.

DRUG

Olmesartan medoxomil

Olmesartan medoxomil supplied as 10 mg tablets taken once a day during Treatment Phase 1 only.

DRUG

Amlodipine+valsartan

Fixed-dose combination of amlodipine 10 mg plus valsartan 160 mg tablet taken orally once a day during Treatment Phase 2 and Extension Phase.

DRUG

Hydrochlorothiazide

Hydrochlorothiazide (HCTZ) 12.5 mg tablets taken once a day during the Extension Phase.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Sponsor GmbH

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
2007-07-31
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • Germany

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 NCT00523744 on ClinicalTrials.gov