SPP100 (Aliskiren) regimen in patients with severe hypertensio
Phase 3
- Conditions
- Hypertension
- Registration Number
- JPRN-jRCT2080220236
- Lead Sponsor
- ovartis Pharma K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 38
Inclusion Criteria
Inclusion criteria
- Age: 20-80 years old
- Gender: Male or female
- Status: Outpatients
- Severe hypertension
Exclusion criteria
- Patients with a clinically significant allergy
- Patients who have received other investigational drug
- Alcoholic patients
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: Incidence of adverse events after 8 weeks Secondary Outcomes: Change from baseline in mean sitting systolic and diastolic blood pressure after 8 weeks; Average sitting systolic blood pressure/mean sitting diastolic blood is < 160/100 mmHg or blood pressure reduction from baseline is > 20/10 mmHg after 8 weeks; Average sitting diastolic blood pressure < 90 mmHg or a reduction from baseline of > 10 mmHg after 8 weeks
- Secondary Outcome Measures
Name Time Method