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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2009

Intervention(s) in this Clinical Trial

• Drug: valsartan and amlodipine
  • once daily
• Drug: valsartan and amlodipine
  • once daily

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • 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
• Active Comparator: 2
  • 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

Primary Measures

• Change in Mean Sitting Systolic Blood Pressure (herein, MSSBP) after 4 weeks
  • Time Frame: 4 weeks
    Safety Issue?: No

Secondary Measures

• Proportion of patients achieving blood pressure goal (<140/90 mmHg), at 2, 4, 8 and 12 weeks
  • Time Frame: 12 weeks
    Safety Issue?: No

Inclusion Criteria:

• 18 Years of age or older
• Mean Sitting Systolic Blood Pressure (the top number) of or higher than 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) of or higher than 200 mmHg and/or Mean Sitting Diastolic Blood Pressure of or higher than 120 mmHg
• Transient ischemic attack (mini-stroke), myocardial infarction (heart attack), all types of revascularization procedures in the last 6 months

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 Sponsor: Novartis

Information obtained from ClinicalTrials.gov on July 02, 2009

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