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

Novartis

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: HCTZ; Drug: Valsartan + HCTZ; Drug: Valsartan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00698646

CVAH631BUS08

Details and patient eligibility

About

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

Enrollment: 384 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

384 participants in 3 patient groups

Valsartan

Active Comparator group

Description:

(patients initiated on valsartan)

Treatment:

Drug: Valsartan

HCTZ

Active Comparator group

Description:

(patients initiated on HCTZ)

Treatment:

Drug: HCTZ

Valsartan + HCTZ

Experimental group

Description:

(patients initiated on Valsartan+HCTZ)

Treatment:

Drug: Valsartan + HCTZ