NCT00386607

A Safety and Tolerability Study of the Combination of Aliskiren/Valsartan in Patients With High Blood Pressure, Followed by Long-term Safety and Tolerability of Aliskiren, Valsartan and Hydrochlorothiazide.

A 54-week, Open-label, Multicenter Study to Assess the Long-term Safety and Tolerability of the Combination of Aliskiren 300 mg /Valsartan 320 mg in Patients With Essential Hypertension Followed by a 26 Week Open-label Extension to Assess the Long-term Safety and Tolerability of the Triple Combination of Aliskiren/Valsartan/Hydrochlorothiazide(HCTZ)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 601 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Assessment of the long-term safety and tolerability of the combination of aliskiren and valsartan (300 mg/ 320 mg) in patients with high blood pressure,followed by assessment of long-term safety and tolerability of the combination of aliskiren/valsartan/Hydrochlorothiazide(HCTZ).

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Aliskiren	Aliskiren 300 mg
DRUG	Valsartan	Valsartan 320 mg
DRUG	Hydrochlorothiazide (HCTZ)	Hydrochlorothiazide (HCTZ) 12.5-25 mg

Timeline

• Start date: 2006-10-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2006-10-11
• Last updated: 2014-02-10
• Results posted: 2011-05-10

Locations

4 sites across 4 countries: United States, Canada, Germany, Netherlands