NCT01237873CompletedPhase 3
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)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Long-term safety of the fixed-dose combination of aliskiren/ amlodipine
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Experimental
Aliskiren/Amlodipine 150/2.5 mg and 150/5.0 mg
Intervention: Ali/Amlo 150/2.5 mg (Drug)
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)
Investigators
Study Sites (1)
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