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

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Amlodipine

Criteria

Inclusion Criteria:

• Patients that complete CSPA100A1301 study

• Patients whose blood pressure at Visit 7 of CSPA100A1301 study must be well controlled

Exclusion Criteria:

• Patients who experienced any serious adverse events considered drug related in CSPA100A1301 study

• Presence of major protocol violation in CSPA100A1301 study

Other protocol-defined inclusion/exclusion criteria may apply