NCT00705575

Efficacy and Safety of the Combination Aliskiren (300 mg) and Hydrochlorothiazide (25mg) to Aliskiren (300mg) Monotherapy in Patients With Staged II Hypertension

A 12 Week, Double-blind, Randomized, Parallel Group, Multi-center Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren 300 mg and Hydrochlorothiazide 25 mg Compared to Aliskiren 300 mg in Patients With Stage II Hypertension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 688 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will compare the efficacy and safety of once daily dosing of aliskiren monotherapy to once daily dosing of aliskiren and hydrochlorothiazide combination therapy in patients with Stage II hypertension over a period of 12 weeks.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Aliskiren/hydrochlorothiazide (HCTZ) (300/25 mg)	During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week.
DRUG	Aliskiren (300 mg)	During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.

Timeline

• Start date: 2008-06-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2008-06-26
• Last updated: 2011-05-30
• Results posted: 2011-01-21

Locations

8 sites across 8 countries: United States, Argentina, Ecuador, Germany, Guatemala, Italy, Switzerland, Turkey (Türkiye)