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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Valsartan + HCTZ
* Drug: Valsartan
* Drug: HCTZ


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Valsartan<br>(patients initiated on valsartan) | Drug: Valsartan<br>* 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.<br>|
| Active Comparator: HCTZ<br>(patients initiated on HCTZ) | Drug: HCTZ<br>* 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.<br>|
| Experimental: Valsartan + HCTZ<br>(patients initiated on Valsartan+HCTZ) | Drug: Valsartan + HCTZ<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Week 4 in Office Cuff Mean Sitting Systolic Blood Pressure (MSSBP) |  | Baseline and Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Cumulative refers to achieving of blood pressure control before or at the corresponding visit. | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Systolic blood pressure, Diastolic blood pressure, Valsartan, Hydrochlorothiazide