CompletedPhase 4

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

United States384 participantsStarted 2008-04

Plain-language 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

Who can participate

Age range70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change From Baseline to Week 4 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)

Timeframe: Baseline and Week 4

Trial details

NCT IDNCT00698646

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-06

Results submitted2010-11-16

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