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Trial record 24 of 100 for:    AMLODIPINE AND VALSARTAN

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

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ClinicalTrials.gov Identifier: NCT00666536
Recruitment Status : Completed
First Posted : April 25, 2008
Results First Posted : December 10, 2010
Last Update Posted : October 27, 2016
Sponsor:
Information provided by:
Novartis

Tracking Information
First Submitted Date  ICMJE April 23, 2008
First Posted Date  ICMJE April 25, 2008
Results First Submitted Date  ICMJE November 16, 2010
Results First Posted Date  ICMJE December 10, 2010
Last Update Posted Date October 27, 2016
Study Start Date  ICMJE March 2008
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2011)
Change From Baseline to Week 4 in Mean Sitting Systolic Blood Pressure (MSSBP) [ Time Frame: Baseline and Week 4 ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 24, 2008)
Change in Mean Sitting Systolic Blood Pressure (herein, MSSBP) after 4 weeks [ Time Frame: 4 weeks ]
Change History Complete list of historical versions of study NCT00666536 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2011)
  • 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 ]
  • Change From Baseline to Week 4 in Mean Sitting Diastolic Blood Pressure (MSDBP) [ Time Frame: Baseline and Week 4 ]
  • Change From Baseline to Weeks 2, 8 and 12 in MSSBP [ Time Frame: 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 ]
  • Percentage of Patients Achieving BP Goal of MSSBP < 140mmHg at Weeks 2, 4, 8 and 12 [ Time Frame: Weeks 2, 4, 8 and 12 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2008)
Proportion of patients achieving blood pressure goal (<140/90 mmHg), at 2, 4, 8 and 12 weeks [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Moderate vs. Aggressive Treatment With Valsartan + Amlodipine on Patients With Hypertension Uncontrolled by Angiotensin-Receptor Blocker (Herein, ARB) Monotherapy
Official Title  ICMJE 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
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 uncontrolled on ARB monotherapy, other than Valsartan
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE Drug: valsartan and amlodipine
Study Arms  ICMJE
  • 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)
    Intervention: 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)
    Intervention: Drug: valsartan and amlodipine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 31, 2008)
728
Original Estimated Enrollment  ICMJE
 (submitted: April 24, 2008)
678
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00666536
Other Study ID Numbers  ICMJE CVAA489AUS02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis, pharmaceuticals
Study Sponsor  ICMJE Novartis
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Suzanne Oparil, MD et al University of Alabama at Birmingham
PRS Account Novartis
Verification Date April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP