Official Title: “A 16 Week Multi-Center, Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Valsartan/Hydrochlorothiazide (HCTZ) Combination Therapy Compared to Patients Initiated With Valsartan Monotherapy or Hydrochlorothiazide Monotherapy in Very Elderly Patients With Essential Hypertension”

The purpose of the study is to evaluate the safety and efficacy of initial treatment therapy with valsartan/HCTZ versus the initial treatment therapy with monotherapies (valsartan or hydrochlorothiazide in the very elderly patients (greater than or equal to 75 years) with stage 1 or 2 hypertension

Study Type: Interventional

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

Study Primary Completion Date: April 2009

Intervention(s) in this Clinical Trial

• Drug: valsartan + HCTZ
  • Combination valsartan + HCTZ 320 mg/ 12.5 mg : 4 weeks (optional) Combination valsartan + HCTZ 320 mg/ 25 mg :8 weeks (optional)
• Drug: Valsartan
  • Combination valsartan + HCTZ 160 mg/ 12.5 mg : 4 weeks (optional) Combination valsartan + HCTZ 320 mg/ 12.5 mg :4 weeks (optional) Combination valsartan + HCTZ 320 mg/ 25 mg :4 weeks (optional)
• Drug: HCTZ
  • 12.5 mg 4 weeks Combination valsartan + HCTZ 160 mg/ 12.5 mg : 4 weeks (optional) Combination valsartan + HCTZ 320 mg/ 12.5 mg : 4 weeks (optional) Combination valsartan + HCTZ 320 mg/ 25 mg : 4 weeks (optional)

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 2
  • Valsartan160 mg Arm
• Active Comparator: 3
  • HCTZ 12.5 mg Arm
• Active Comparator: 1
  • Combination valsartan + HCTZ 160 mg/ 12.5 mg Arm

Primary Measures

• Change in MSSBP after initial 4 weeks of treatment
  • Time Frame: 4 weeks
    Safety Issue?: Yes

Secondary Measures

• Change from baseline in office cuff MSDBP week 4, 8, 12 and 16
  • Time Frame: 16 weeks
    Safety Issue?: No
• Change from baseline in office cuff MSSBP week 8, 12, and 16
  • Time Frame: 16 weeks
    Safety Issue?: No
• Percent of patients achieving BP control (defined as BP < 140/90 mmHg) at week 4, week 8, 12 and 16
  • Time Frame: 16 weeks
    Safety Issue?: No
• Percent of patients achieving BP goal (SBP<140 mmHg) at week 4, 8, 12 and 16.
  • Time Frame: 16 weeks
    Safety Issue?: No
• 5. Time to achieving the first treatment success (defined as the time of the first achievement of the target blood pressure goal (<140 and <90 mmHg)) during 16 weeks
  • Time Frame: 16 weeks
    Safety Issue?: No

Inclusion Criteria:

• Age 75 years or older.
• Patients with hypertension prior to being randomized into study.
• Patients must have an office cuff MSSBP ≥150 and ≤200 mmHg systolic.
• Have the ability to communicate and comply with all study requirements.
• Provide written informed consent to participate in the study prior to any screening or study procedures.

Exclusion Criteria:

• Use of other investigational drugs within 30 days of enrollment.
• History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
• Office blood pressure measured by office machine cuff with a mean of (3) MSDBP > 120 mmHg at anytime during the screening / washout period.
• Patients taking 3 or more antihypertensive drugs and MSSBP >160 mmHg at the time of Visit 1.
• Other protocol-defined inclusion/exclusion criteria may apply

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 75 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Overall Contact: Novartis Pharmaceuticals 862-778-8300 

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00698646

Study ID Number: CVAH631BUS08

ClinicalTrials.gov Identifier: NCT00698646

Health Authority: United States: Food and Drug Administration