Status:

COMPLETED

The Effects of Moderate vs. Aggressive Treatment With Valsartan + Amlodipine on Patients With Hypertension Uncontrolled by Angiotensin-Receptor Blocker (Herein, ARB) Monotherapy

Lead Sponsor:

Novartis

Conditions:

Hypertension

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

The purpose of this trial is to compare blood pressure lowering efficacy of moderate Valsartan + Amlodipine treatment regimen (160 / 5 mg) with that of aggressive regimen (320 / 10 mg) in patients unc...

Eligibility Criteria

Inclusion

  • Male and female outpatients
  • 18 Years of age or older
  • Mean Sitting Systolic Blood Pressure (the top number) greater than or equal to 150 mmHg and lower than 200 mmHg while on Angiotensin-Receptor Blocker monotherapy for a minimum period of 28 days prior to randomization

Exclusion

  • Mean Sitting Systolic Blood Pressure (the top number) greater than or equal to 200 mmHg and/or Mean Sitting Diastolic Blood Pressure greater than or equal to 120 mmHg
  • Transient ischemic attack (mini-stroke), myocardial infarction (heart attack), all types of revascularization procedures in the last 6 months
  • Treatment with valsartan or any combination antihypertensive treatment with 28 days prior to screening (Visit 1)

Key Trial Info

Start Date :

March 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

728 Patients enrolled

Trial Details

Trial ID

NCT00666536

Start Date

March 1 2008

Last Update

October 27 2016

Active Locations (1)

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1

Egan Healthcare

Metairie, Louisiana, United States, 70002