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

Phase 4

Completed

• Conditions: High Blood Pressure
• Interventions: Drug: Aliskiren and HCTZ

• Registration Number: NCT01056731
• Lead Sponsor: Novartis

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-25
• Study First Submitted QC: 2010-01-25
• Study First Posted: 2010-01-26
• Study Start: 2010-02
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-21
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 253

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aliskiren and Aliskiren_HCTZ	Aliskiren and HCTZ	aliskiren 150 mg and 300 mg Hydrochlorothiazide 12.5 mg 25 mg

Primary Outcome Measures

Name	Time	Method
The proportion of patients in whom BP control was achieved at the study end point	16 weeks

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Investigative Site; 🇻🇪 Maracaibo Estado Zulia, Venezuela