Double-blind study of VAH631 in patients with essential hypertension (factorial study)
Phase 3
- Conditions
- Hypertension
- Registration Number
- JPRN-jRCT2080220234
- Lead Sponsor
- ovartis Pharma K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 558
Inclusion Criteria
Inclusion criteria
- Essential hypertension measured by mercury sphygmomanometer
- Outpatients
- Male or female aged 20 to 80 years old
Exclusion criteria
- Secondary hypertension or suspected of having secondary hypertension.
- A history of malignant hypertension
- Severe hypertension
- Significant heart, renal, hepatic diseases or significant cerebrovascular disorder
- Gout
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: Change from baseline in diastolic blood pressure after 8 weeks Secondary Outcomes: Change from baseline in systolic blood pressure after 8 weeks; Diastolic blood pressure less than 90 mmHg or at least a 10 mmHg decrease in diastolic blood pressure after 8 weeks; Change from baseline in standing diastolic blood pressure after 8 weeks; Change from baseline in standing systolic blood pressure after 8 weeks; Adverse events and serious adverse events at each study visit for 8 weeks
- Secondary Outcome Measures
Name Time Method