Status:
COMPLETED
Long Term Safety of SPA100 (Fixed-dose Combination of Aliskiren/Amlodipine) in Patients With Essential Hypertension
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Essential Hypertension
Eligibility:
All Genders
20+ years
Phase:
PHASE3
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 conduct...
Eligibility Criteria
Inclusion
- Patients that complete CSPA100A1301 study
- Patients whose blood pressure at Visit 7 of CSPA100A1301 study must be well controlled
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01237873
Start Date
January 1 2011
End Date
February 1 2012
Last Update
February 23 2017
Active Locations (13)
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1
Novartis Investigative Site
Yokohama, Kanagawa, Japan, 231-0023
2
Novartis Investigative Site
Koshigaya, Saitama, Japan, 343-0826
3
Novartis Investigative Site
Edogawa-ku, Tokyo, Japan, 133-0061
4
Novartis Investigative Site
Katsushika-ku, Tokyo, Japan, 124-0024