A Clinical Study to Evaluate the Long-term Safety (12 Months) of the Combination of Aliskiren 300 mg and Hydrochlorothiazide 25 mg
Not Applicable
- Conditions
- -I10 Essential (primary) hypertensionEssential (primary) hypertensionI10
- Registration Number
- PER-037-04
- Lead Sponsor
- OVARTIS BIOSCIENSES PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
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 Criteria
underage
healthy people
pregnant women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:reporting of adverse events and serious adverse events, including deaths<br>Measure:Assessment of safety through reporting of adverse events and serious adverse events, including deaths<br>Timepoints:12 month<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:blood pressure<br>Measure:Change from baseline in mean diastolic blood pressure after 4 months<br>Timepoints:4 months<br>