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OpenTrials
Completed

NCT Number: NCT00666536

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Egan Healthcare

Metairie, Louisiana, 70002, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

valsartan and amlodipine

Drug

Primary outcomes

  1. Change From Baseline to Week 4 in Mean Sitting Systolic Blood Pressure (MSSBP)

    Time frame: Baseline and Week 4

Secondary outcomes

  1. 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

  2. Change From Baseline to Week 4 in Mean Sitting Diastolic Blood Pressure (MSDBP)

    Time frame: Baseline and Week 4

  3. Change From Baseline to Weeks 2, 8 and 12 in MSSBP

    Time frame: Baseline and Weeks 2, 8 and 12

  4. Change From Baseline to Weeks 2, 8 and 12 in MSDBP

    Time frame: Baseline and Weeks 2, 8 and 12

  5. Percentage of Patients Achieving BP Goal of MSSBP < 140mmHg at Weeks 2, 4, 8 and 12

    Time frame: Weeks 2, 4, 8 and 12

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

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

Acronym: EXTRA

Important dates

Study start
2008
Primary completion
2009
First posted
Apr 25, 2008
Registry last updated
Oct 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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