Blood Pressure Lowering of Aliskiren HCTZ Compared to HCTZ in Stage 2 Systolic Hypertension in Older Population

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the efficacy and safety of initial use of a fixed dose combination of aliskiren Hydrochlorothiazide (HCTZ) compared to Hydrochlorothiazide in older population with Stage 2 systolic hypertension.

Official Title
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An 8-week Randomized, Double-blind, Parallel-group, Multi-center, Active-controlled Dose Escalation Study to Evaluate the Efficacy and Safety of Aliskiren HCTZ (300/25 mg) Compared to HCTZ (25 mg) in Older Patients With Stage 2 Systolic Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Aliskiren
* Drug: Hydrochlorothiazide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female outpatients, ≥ 55 years old Patients with essential hypertension Prior to randomization: Patients must have an office cuff mean sitting Systolic Blood Pressure ≥ 160 mm Hg and < 200 mm Hg Patients who are eligible and able to participate in the study, and who are willing to give informed consent before any assessment is performed Exclusion Criteria: Office blood pressure measured by cuff (msSBP ≥ 200 mm Hg and/or msDBP ≥ 110 mm Hg) at Visits 1-5 History or evidence of a secondary hypertension of any etiology (e.g., uncorrected renal artery stenosis, pheochromocytoma). History of hypertensive encephalopathy or heart failure (New York Heart Association [NYHA] Class II-IV) Cerebrovascular accident, transient ischemic cerebral attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI) within 1 year prior to Visit 1 Serum sodium less than the lower limit of normal, serum potassium < 3.5 mEq/L (corresponding to 3.5 mmol/L) or ≥ 5.3 mEq/L (corresponding to 5.3 mmol/L), or dehydration at Visit 1. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL) Use of other investigational drugs within 30 days of enrollment. Other exclusions may apply.

Ages Eligible for Study
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Minimum Age: 55 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 |
| --- | --- |
| Experimental: Aliskiren/HCTZ 300/25 mg<br> | Drug: Aliskiren<br>* Aliskiren 150 mg for 1 week, Aliskiren 300 mg (with or without amlodipine)for 7 weeks<br>|
| Active Comparator: HCTZ 25 mg<br> | Drug: Hydrochlorothiazide<br>* Hydrochlorothiazide (HCTZ) 12.5 mg for week 1; Hydrochlorothiazide (HCTZ) 25 mg (with or without amlodipine)for 7 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 4 |  | Baseline and Week 4 | 
| Change in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (in Patients With msDBP ≥90 mmHg at Baseline) From Baseline to Week 8 |  | Baseline and Week 8 | 
| Percentage of Responders at Week 4 and Week 8 | Responders defined as mean sitting Systolic Blood Pressure < 140 mmHg or reduction of ≥ 20 mmHg from baseline | At 4 weeks and 8 weeks | 
| Percentage of Subjects Achieving Blood Pressure Control at Weeks 4 and 8 | Blood pressure control defined as mean sitting Systolic Blood Pressure < 140 mm Hg and mean sitting Diastolic Blood Pressure < 90 mm Hg | At Weeks 4 and 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, older population, aliskiren, hydrochlorothiazide, systolic blood pressure, diastolic blood pressure, amlodipine, stage 2