NCT01113047

Aliskiren in Combination With Amlodipine in Hypertensive Patients Not Responding to Angiotensin Receptor Blocker (ARB) Plus Amlodipine

An Open-label, Multicenter Study to Evaluate the Efficacy and Safety of a 4 Week Therapy With the Single Pill (SPC) Combination of Aliskiren 300 mg / Amlodipine 10 mg in Hypertensive Patients Not Adequately Respond to an Uptitrated 4 Week Therapy With the SPC of Olmesartan 40 mg / Amlodipine 10 mg, With a Potential Extension if Patients Still Not Adequately Respond With a 4 Week Therapy With the SPC Aliskiren 300 mg / Amlodipine 10 mg / HCTZ 12,5 mg

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 347 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the efficacy and safety of the single pill combination of Aliskiren and Amlodipine in patients with moderate hypertension not adequately responding to a single pill combination of Olmesartan and Amlodipine. Further this study will also assess the efficacy and safety of a single pill combination of Aliskiren, Amlodipine and Hydrochlorothiazide (HCTZ) in patients with moderate hypertension not adequately responding to a single pill combination of Aliskiren and Amlodipine.

Conditions

• Essential Hypertension

Interventions

Type	Name	Description
DRUG	Aliskiren/Amlodipine and Aliskiren/Amlodipine/HCTZ	Aliskiren 300 mg / Amlodipine 10 mg/HCTZ 12.5 mg

Timeline

• Start date: 2010-05-01
• Primary completion: 2010-10-01
• First posted: 2010-04-29
• Last updated: 2013-12-06

Locations

1 site across 1 country: Germany