A Clinical Study With Aliskiren Alone or in Combination Therapy With Diuretic Hctz in Venezuelan Hypertensive Patients.

Study Overview
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Brief Summary
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This is an open-label, not controlled, sequential, dose escalation study of 16 weeks' duration. The study is composed of two periods: a 0-2 week optional wash-out period depending on previous antihypertensive treatment(s), followed by a 16-week open-label active treatment period. Patients will be evaluated every 4 weeks during period 2. Treatment will start with Aliskiren 150 mg with dose titration to Aliskiren 300 mg, and addition of HCTZ 12,5 mg and 25 if control of BP is not achieved (< 140/90 mmHg or 130/ 80 mmHg in diabetics patients). All patients who have reached their BP target will be considered as having met the primary endpoint and this visit will be considered as the final visit.

Official Title
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A 16-week, Prospective, Open Label, Multicenter Study to Evaluate the Effectiveness and Safety of Rasilez® (Aliskiren) Monotherapy or in Addition With Hydrochlorothiazide 12.5 mg or 25 mg in Patients With Hypertension Stage I and II

Conditions
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High Blood Pressure

Intervention / Treatment
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* Drug: Aliskiren and HCTZ


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatients, with essential hypertension, stage I-II, naïve or not controlled with monotherapy. Exclusion Criteria: BP> 180/110 mmHg Pregnant or nursing women Hypertensive encephalopathy or cerebrovascular accident, transient ischemic - cerebral attack, myocardial infarction, unstable angina, coronary bypass surgery, percutaneous coronary intervention within 6 month K <3.5 mEq/L or ≥ 5 mEq/L Renal impairment Hypersensitivity to HCTZ or Aliskiren or angioedema due to ACE-I or ARB Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aliskiren and Aliskiren_HCTZ<br>aliskiren 150 mg and 300 mg Hydrochlorothiazide 12.5 mg 25 mg | Drug: Aliskiren and HCTZ<br>* Aliskiren 150 mg and 300 mg Hydrochlorothiazide 12.5 mg and 25 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients in whom BP control was achieved at the study end point |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients in whom BP control was reached before the addition of HCTZ (ie, at the pre-HCTZ end point |  | 8 weeks | 
| Percentage of patients achieving overall BP, DBP, an SBP control rate at week 4, 8, 12 and 16. |  | 16 weeks | 
| Change in msSPA and msDBP from baseline to different time points |  | 4,8,12 and 16 weeks | 
| Safety of Aliskiren therapy at different time points |  | 4,8,12 and 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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high blood pressure, aliskiren, hydrochlorothiazide, control rate