A Clinical Study to Evaluate the Long-term Safety (12 Months) of the Combination of Aliskiren 300 mg and Hydrochlorothiazide 25 mg
Phase 3
Completed
- Conditions
- Hypertension
- Registration Number
- NCT00171405
- Lead Sponsor
- Novartis
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Assessment of safety through reporting of adverse events and serious adverse events, including deaths, following a 12 month study
- Secondary Outcome Measures
Name Time Method Change from baseline (following a 12 month study) in mean sitting diastolic blood pressure after 4 months Change from baseline (following a 12 month study) in mean sitting systolic blood pressure after 4 months Change from baseline (following a 12 month study) in mean standing blood pressure after 4 months Diastolic blood pressure less than 90 mmHg or 10 mmHg or greater change from baseline Blood pressure less than 140/90 mmHg
Trial Locations
- Locations (1)
Investigative Site
🇬🇧London, United Kingdom