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

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: Valsartan + HCTZ; Drug: Valsartan; Drug: HCTZ

• Registration Number: NCT00698646
• Lead Sponsor: Novartis Pharmaceuticals

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-06-13
• Study First Submitted QC: 2008-06-16
• Study First Posted: 2008-06-17
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Results First Submitted: 2010-11-16
• Results First Submitted QC: 2010-11-16
• Results First Posted: 2010-12-15
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-15
• Last Update Posted: 2011-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 384

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Valsartan + HCTZ	Valsartan + HCTZ	(patients initiated on Valsartan+HCTZ)
Valsartan	Valsartan	(patients initiated on valsartan)
HCTZ	HCTZ	(patients initiated on HCTZ)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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 refers to achieving of blood pressure control before or at the corresponding visit.
Cumulative Percentage of Patients Achieving Blood Pressure Goal (MSSBP < 140 mmHg)	Weeks 4, 8, 12 and 16	Cumulative refers to achieving blood pressure goal before or at the corresponding visit.
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

Trial Locations

Locations (3)

Investigative Site; 🇺🇸 Taylors, South Carolina, United States

Investigative Sites; 🇺🇸 Pismo Beach, California, United States

Investigative site; 🇺🇸 St George, Utah, United States