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

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Hydrochlorothiazide; Valsartan

Criteria

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