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Valsartan Intensified Primary Care Reduction of Blood Pressure Study

NCT00902304 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2337

Last updated 2012-12-04

Study results available
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Summary

This study will assess the efficacy of an intensive blood pressure management strategy compared to usual care in a primary care (general practice) setting.

Conditions

Interventions

DRUG

Valsartan and hydrochlorothiazide (HCTZ) - monotherapy

Monotherapy arm - if monotherapy valsartan 320mg per day orally was not sufficient, then could add HCTZ up to 25 mg per day orally

DRUG

Valsartan and amlodipine

From valsartan 80mg/amlodipine 5mg per day to valsartan 160mg/amlodipine 10mg per day orally

DRUG

Usual care

As directed by investigator

DRUG

Valsartan

Valsartan 160mg per day to 320mg per day orally

DRUG

Valsartan and hydrochlorothiazide (HCTZ) - combination arm

Combination arm - from valsartan 80mg/hydrochlorothiazide 12.5mg per day to valsartan 160mg/hydrochlorothiazide 25mg per day orally

Sponsors & Collaborators

Principal Investigators

  • Study Director · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • United States
  • Australia

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 NCT00902304 on ClinicalTrials.gov