NCT01056731

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 253 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• High Blood Pressure

Interventions

Type	Name	Description
DRUG	Aliskiren and HCTZ	Aliskiren 150 mg and 300 mg Hydrochlorothiazide 12.5 mg and 25 mg

Timeline

• Start date: 2010-02-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2010-01-26
• Last updated: 2017-02-23

Locations

7 sites across 1 country: Venezuela