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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

253 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-10-31

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.

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Detailed Description

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Conditions

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High Blood Pressure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aliskiren and Aliskiren_HCTZ

aliskiren 150 mg and 300 mg Hydrochlorothiazide 12.5 mg 25 mg

Group Type EXPERIMENTAL

Aliskiren and HCTZ

Intervention Type DRUG

Aliskiren 150 mg and 300 mg Hydrochlorothiazide 12.5 mg and 25 mg

Interventions

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Aliskiren and HCTZ

Aliskiren 150 mg and 300 mg Hydrochlorothiazide 12.5 mg and 25 mg

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No