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

Novartis Pharmaceuticals3 sites in 1 country384 target enrollmentApril 2008

ConditionsHypertension

InterventionsValsartan HCTZ Valsartan + HCTZ

DrugsValsartan + HCTZ Valsartan HCTZ

Overview

Phase: Phase 4
Intervention: Valsartan
Conditions: Hypertension
Sponsor: Novartis Pharmaceuticals
Enrollment: 384
Locations: 3
Primary Endpoint: Change From Baseline to Week 4 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

April 2008

End Date

June 2009

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Eligibility 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
•Other protocol-defined exclusion criteria may apply

Arms & Interventions

Valsartan

(patients initiated on valsartan)

Intervention: Valsartan

HCTZ

(patients initiated on HCTZ)

Intervention: HCTZ

Valsartan + HCTZ

(patients initiated on Valsartan+HCTZ)

Intervention: Valsartan + HCTZ

Outcomes

Primary Outcomes

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

Time Frame: Baseline and Week 4

Secondary Outcomes

Change From Baseline to Week 4, 8, 12 and 16 in Office Cuff Mean Sitting Diastolic Blood Pressure (MSDBP)(Baseline and Weeks 4, 8, 12 and 16)
Change From Baseline to Weeks 8, 12 and 16 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP)(Baseline and Weeks 8, 12, and 16)
Cumulative Percentage of Patients Achieving the Blood Pressure Control of < 140/90 mmHg(Weeks 4, 8, 12 and 16)
Cumulative Percentage of Patients Achieving Blood Pressure Goal (MSSBP < 140 mmHg)(Weeks 4, 8, 12 and 16)
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])(During 16 weeks)