NCT00760266

Blood Pressure Lowering of Aliskiren HCTZ Compared to HCTZ in Stage 2 Systolic Hypertension in Older Population

An 8-week Randomized, Double-blind, Parallel-group, Multi-center, Active-controlled Dose Escalation Study to Evaluate the Efficacy and Safety of Aliskiren HCTZ (300/25 mg) Compared to HCTZ (25 mg) in Older Patients With Stage 2 Systolic Hypertension

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 451 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the efficacy and safety of initial use of a fixed dose combination of aliskiren Hydrochlorothiazide (HCTZ) compared to Hydrochlorothiazide in older population with Stage 2 systolic hypertension.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Aliskiren	Aliskiren 150 mg for 1 week, Aliskiren 300 mg (with or without amlodipine)for 7 weeks
DRUG	Hydrochlorothiazide	Hydrochlorothiazide (HCTZ) 12.5 mg for week 1; Hydrochlorothiazide (HCTZ) 25 mg (with or without amlodipine)for 7 weeks

Timeline

• Start date: 2008-09-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2008-09-26
• Last updated: 2011-04-04
• Results posted: 2011-01-21

Locations

1 site across 1 country: United States