NCT01237873

Long Term Safety of SPA100 (Fixed-dose Combination of Aliskiren/Amlodipine) in Patients With Essential Hypertension

A Open-label, 52 Week, Extension to an 8-week, Double Blind, Multicenter, 6-arm, Placebo-controlled, Parallel Group Study to Evaluate the Long Term Safety of SPA100 (Aliskiren/Amlodipine)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the long-term safety and tolerability of the combination of aliskiren and amlodipine given to patients with essential hypertension. This study is being conducted to support registration of the fixed combination of aliskiren/amlodipine in the treatment for hypertension in Japan.

Conditions

• Essential Hypertension

Interventions

Type	Name	Description
DRUG	Ali/Amlo 150/2.5 mg	Aliskiren/Amlodipine 150/2.5 mg and 150/5.0 mg

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2010-11-10
• Last updated: 2017-02-23

Locations

13 sites across 1 country: Japan