ong term study of Valsartan and Amlodipine in patients with essential hypertension (extension from Study CVAA489A1301)
Phase 3
- Conditions
- Hypertension
- Registration Number
- JPRN-jRCT2080220359
- Lead Sponsor
- ovartis Pharma K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
Inclusion criteria
- Participation in Study CVAA489A1301
- Patients whose blood pressure at Visit 7 of the Study CVAA489A1301 trial was well controlled
- Male or female outpatients
Exclusion criteria
- Presence of major protocol violation in Study CVAA489A1301
- Patients who experienced any adverse events considered serious and drug related in Study CVAA489A1301
Other protocol-defined inclusion/exclusion criteria may apply
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Outcomes: Safety assessed by serious and non-serious adverse events Secondary Outcomes: -Efficacy assessed by the changes-from baseline measurements in mean sitting diastolic blood pressure, mean sitting systolic blood pressure, standing diastolic blood pressure, and standing systolic blood pressure -Laboratory tests -Vital signs -Electrocardiogram (ECG)
- Secondary Outcome Measures
Name Time Method