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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00666536
First received: April 23, 2008
Last updated: April 19, 2011
Last verified: April 2011
  Purpose

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


Condition Intervention Phase
Hypertension
Drug: valsartan and amlodipine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change From Baseline to Week 4 in Mean Sitting Systolic Blood Pressure (MSSBP) [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 4 in Mean Sitting Diastolic Blood Pressure (MSDBP) [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
  • Change From Baseline to Weeks 2, 8 and 12 in MSSBP [ Time Frame: Baseline and Weeks 2, 8 and 12 ] [ Designated as safety issue: No ]
  • Change From Baseline to Weeks 2, 8 and 12 in MSDBP [ Time Frame: Baseline and Weeks 2, 8 and 12 ] [ Designated as safety issue: No ]
  • Percentage of Patients Achieving BP Goal of MSSBP < 140mmHg at Weeks 2, 4, 8 and 12 [ Time Frame: Weeks 2, 4, 8 and 12 ] [ Designated as safety issue: No ]

Enrollment: 728
Study Start Date: March 2008
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00666536

Locations
United States, Louisiana
Egan Healthcare
Metairie, Louisiana, United States, 70002
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Suzanne Oparil, MD et al University of Alabama at Birmingham
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis, pharmaceuticals
ClinicalTrials.gov Identifier: NCT00666536     History of Changes
Other Study ID Numbers: CVAA489AUS02
Study First Received: April 23, 2008
Results First Received: November 16, 2010
Last Updated: April 19, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Novartis:
Hypertension
adults
Valsartan + Amlodipine
Angiotensin Receptor Blockers

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Valsartan
Amlodipine, valsartan drug combination
Angiotensin Receptor Antagonists
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers

ClinicalTrials.gov processed this record on July 22, 2014