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

Novartis

Status and phase: Completed; Phase 3

Conditions: Essential Hypertension

Treatments: Drug: Ali/Amlo 150/2.5 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01237873

CSPA100A1302

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Ali/Amlo

Experimental group

Description:

Aliskiren/Amlodipine 150/2.5 mg and 150/5.0 mg

Treatment:

Drug: Ali/Amlo 150/2.5 mg