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 (ANDROMEDA)

NCT01056731 Phase 4 COMPLETED

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.

Details

Lead sponsor	Novartis
Phase	Phase 4
Status	COMPLETED
Enrolment	253
Start date	2010-02
Completion	2011-10

Conditions

• High Blood Pressure

Interventions

• Aliskiren and HCTZ

Primary outcomes

• The proportion of patients in whom BP control was achieved at the study end point — 16 weeks

Countries

Venezuela