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

September 20, 2016 updated by: Novartis

A Multicenter, Randomized, Double Blind, Parallel Design Trial to Evaluate the Blood Pressure Lowering Efficacy Comparing Moderate Versus Aggressive Treatment Regimen of Valsartan + Amlodipine in Patients Uncontrolled on ARB Monotherapy

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 uncontrolled on ARB monotherapy, other than Valsartan

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

728

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Metairie, Louisiana, United States, 70002
        • Egan Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Aggressive treatment regimen (5/320 mg to 10/320 mg)
Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
Drug: valsartan and amlodipine
Active Comparator: Moderate treatment regimen (5/160 mg)
Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
Drug: valsartan and amlodipine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline to Week 4 in Mean Sitting Systolic Blood Pressure (MSSBP)
Time Frame: Baseline and Week 4
Baseline and Week 4

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Patients Achieving the Blood Pressure (BP) Goal of < 140/90 mmHg at Weeks 2,4,8 and 12
Time Frame: Weeks 2, 4, 8 and 12
Weeks 2, 4, 8 and 12
Change From Baseline to Week 4 in Mean Sitting Diastolic Blood Pressure (MSDBP)
Time Frame: Baseline and Week 4
Baseline and Week 4
Change From Baseline to Weeks 2, 8 and 12 in MSSBP
Time Frame: Baseline and Weeks 2, 8 and 12
Baseline and Weeks 2, 8 and 12
Change From Baseline to Weeks 2, 8 and 12 in MSDBP
Time Frame: Baseline and Weeks 2, 8 and 12
Baseline and Weeks 2, 8 and 12
Percentage of Patients Achieving BP Goal of MSSBP < 140mmHg at Weeks 2, 4, 8 and 12
Time Frame: Weeks 2, 4, 8 and 12
Weeks 2, 4, 8 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Investigators

  • Principal Investigator: Suzanne Oparil, MD et al, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

April 23, 2008

First Submitted That Met QC Criteria

April 24, 2008

First Posted (Estimate)

April 25, 2008

Study Record Updates

Last Update Posted (Estimate)

October 27, 2016

Last Update Submitted That Met QC Criteria

September 20, 2016

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVAA489AUS02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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