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)

Novartis Pharmaceuticals1 site in 1 country150 target enrollmentJanuary 2011

ConditionsEssential Hypertension

InterventionsAli/Amlo 150/2.5 mg

DrugsAli/Amlo 150/2.5 mg

Overview

Phase: Phase 3
Intervention: Ali/Amlo 150/2.5 mg
Conditions: Essential Hypertension
Sponsor: Novartis Pharmaceuticals
Enrollment: 150
Locations: 1
Primary Endpoint: Long-term safety of the fixed-dose combination of aliskiren/ amlodipine
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

January 2011

End Date

February 2012

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

Ali/Amlo

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

Intervention: Ali/Amlo 150/2.5 mg

Outcomes

Primary Outcomes

Long-term safety of the fixed-dose combination of aliskiren/ amlodipine

Time Frame: 52 weeks

Measure the number patients withof AE, SAEs and analyze cahanges in safety labs.

Secondary Outcomes

Measure the change from baseline in blood pressure effects of the combination of aliskiren/ amlodipine.(52 weeks)
The proportion of patients achieving the blood pressure control target of <140/90 mmHg at the end of study(52 weeks)