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

Novartis Pharmaceuticals384 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

384

Conditions

Hypertension

Interventions

Valsartan + HCTZDRUG

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.

ValsartanDRUG

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.

HCTZDRUG

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.

Eligibility

Sex: ALLMin age: 70 Years

Medical Language ↔ Plain English

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

Locations (20)

Investigative site

Birmingham, Alabama, United States

Investigative site

Phoenix, Arizona, United States

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)

Time frame: 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)

Time frame: Baseline and Weeks 8, 12, and 16

Cumulative Percentage of Patients Achieving the Blood Pressure Control of < 140/90 mmHg

Cumulative refers to achieving of blood pressure control before or at the corresponding visit.

Time frame: Weeks 4, 8, 12 and 16

Cumulative Percentage of Patients Achieving Blood Pressure Goal (MSSBP < 140 mmHg)

Cumulative refers to achieving blood pressure goal before or at the corresponding visit.

Time frame: 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])

Time frame: During 16 weeks

Data from ClinicalTrials.gov

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