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

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”

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

Intervention(s) in this Clinical Trial

• Drug: valsartan and amlodipine
• Drug: valsartan and amlodipine

Arms, Groups and Cohorts in this Clinical Trial

• 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)
• 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)

Primary Measures

• Change From Baseline to Week 4 in Mean Sitting Systolic Blood Pressure (MSSBP)
  • Time Frame: Baseline and Week 4
    Safety Issue?: No

Secondary 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
    Safety Issue?: No
• Change From Baseline to Week 4 in Mean Sitting Diastolic Blood Pressure (MSDBP)
  • Time Frame: Baseline and Week 4
    Safety Issue?: No
• Change From Baseline to Weeks 2, 8 and 12 in MSSBP
  • Time Frame: Baseline and Weeks 2, 8 and 12
    Safety Issue?: No
• Change From Baseline to Weeks 2, 8 and 12 in MSDBP
  • Time Frame: Baseline and Weeks 2, 8 and 12
    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
    Safety Issue?: No

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)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Novartis Industry

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00666536

Study ID Number: CVAA489AUS02

ClinicalTrials.gov Identifier: NCT00666536

Health Authority: United States: Institutional Review Board