Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Compared to Valsartan Monotherapy or Hydrochlorothiazide Monotherapy in Elderly (>70) With Mild-moderate Hypertension.

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 (HCTZ) 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/hydrochlorothiazide (HCTZ) versus the initial treatment therapy with monotherapies (valsartan or HCTZ) in the very elderly patients (greater than or equal to 70 years) with stage 1 or 2 hypertension

Intervention(s) in this Clinical Trial

• Drug: Valsartan + HCTZ
  • At week 0 patients received V+HCTZ 160+12.5 mg capsules. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 320+12.5 mg at week 4 and if needed to V+HCTZ 320+25 mg at week 8 or 12.
• Drug: Valsartan
  • At week 0 patients received Valsartan(V) 160 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.
• Drug: HCTZ
  • At week 0 patients received HCTZ 12.5 mg capsule. Subjects not at BP goal <140/90 mmHg were uptitrated to V+HCTZ 160+12.5 mg at week 4 and if needed to V+HCTZ 320+12.5 mg at week 8, and V+HCTZ 320+25 mg at week 12.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Valsartan
  • (patients initiated on valsartan)
• Active Comparator: HCTZ
  • (patients initiated on HCTZ)
• Experimental: Valsartan + HCTZ
  • (patients initiated on Valsartan+HCTZ)

Primary Measures

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

Secondary Measures

• Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)
  • Time Frame: Baseline and Weeks 4, 8, 12 and 16
    Safety Issue?: No
• Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)
  • Time Frame: Baseline and Weeks 8, 12, and 16
    Safety Issue?: No
• Cumulative Percentage of Patients Achieving the Blood Pressure Control of < 140/90 mmHg
  • Time Frame: Weeks 4, 8, 12 and 16
    Safety Issue?: No
• Cumulative Percentage of Patients Achieving Blood Pressure Goal (MSSBP < 140 mmHg)
  • Time Frame: Weeks 4, 8, 12 and 16
    Safety Issue?: No
• Time in Weeks to Achieving the First Treatment Success (Defined as the Time of the First Achievement of the Target Blood Pressure Goal [MSSBP/MSDBP <140/90 mmHg])
  • Time Frame: During 16 weeks
    Safety Issue?: No

Inclusion Criteria:

• Age 70 years or older.
• Patients with hypertension prior to being randomized into study.
• Patients must have an office cuff MSSBP ≥ 140 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 exclusion criteria may apply

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 70 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Novartis Pharmaceuticals Industry

Information obtained from ClinicalTrials.gov on February 12, 2012

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

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