Status:
COMPLETED
Efficacy and Safety of SPA100 (Fixed-dose Combination of Aliskiren/Amlodipine) in Patients With Essential Hypertension
Lead Sponsor:
Novartis
Conditions:
Essential Hypertension
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
The purpose of the study was to evaluate the efficacy (blood pressure lowering effect) and safety of SPA100 (Fixed-dose Combination of Aliskiren and Amlodipine) in patients with essential hypertension...
Eligibility Criteria
Inclusion
- Patients with essential hypertension (msDBP ≥ 95 mmHg and \< 110 mmHg and msSBP ≥140 mmHg )
- Outpatients
Exclusion
- Severe hypertension (msDBP ≥110 mmHg and/or msSBP ≥ 180 mmHg)
- History of allergy or hypersensitivity to renin inhibitors, calcium channel blockers
- History or evidence of a secondary hypertension
- Other protocol-defined inclusion/exclusion criteria applied
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
1342 Patients enrolled
Trial Details
Trial ID
NCT01237223
Start Date
October 1 2010
End Date
May 1 2011
Last Update
June 13 2012
Active Locations (11)
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1
Investigative Site
Aichi, Japan
2
Investigative Site
Ehime, Japan
3
Investigative Site
Fukuoka, Japan
4
Investigative Site
Hokkaido, Japan