Status:
COMPLETED
A Clinical Study to Evaluate the Long-term Safety (12 Months) of the Combination of Aliskiren 300 mg and Hydrochlorothiazide 25 mg
Lead Sponsor:
Novartis
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to collect the long-term (12 months) safety data on aliskiren 300 mg when taken in combination with HCTZ 25 mg.
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- their successful completion of the CSPP100A2302 core study with at least eight months combination treatment of aliskiren 300 mg and HCTZ 25 mg, i.e., patients who received aliskiren 300 mg and HCTZ 25 mg at Month 4 of the core study and complete the core study.
- absence of ongoing severe adverse events at Visit 10.
Exclusion
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
End Date :
February 1 2006
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00171405
Start Date
June 1 2005
End Date
February 1 2006
Last Update
November 18 2016
Active Locations (10)
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1
Investigative Site
East Hanover, New Jersey, United States
2
Investigative Site
Deurne, Belgium
3
Investigative Site
Ste-Fov, Canada
4
Investigative Site
Krassel, Germany