drugset / Trial / NCT01056731

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

NCT01056731

Phase 4 Completed 253 enrolled Novartis
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2010-02
Primary completion
2011-10
Completion
2011-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Aliskiren Small molecule 150 mg
Subject Aliskiren Small molecule 300 mg
Subject Hydrochlorothiazide Unknown 12.5 mg
Subject Hydrochlorothiazide Unknown 25 mg

Indications