SPP100 (Aliskiren) regimen in hypertensive patients with renal dysfunctio
Phase 3
- Conditions
- Hypertension
- Registration Number
- JPRN-jRCT2080220235
- 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
- Elevated Serum Creatinine
Exclusion criteria
- Patients suspected of malignant hypertension
- Patients with a clinically significant allergy
- Patients who have received other investigational drug
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: Adverse events after 8 weeks Secondary Outcomes: Change from baseline in mean sitting systolic blood pressure after 8 weeks; Change from baseline in mean sitting diastolic blood pressure after 8 weeks; Mean sitting systolic blood pressure is < 140 mmHg or a reduction of > 20 mmHg after 8 weeks; Mean sitting diastolic blood pressure is < 90 mmHg or a reduction of > 10 mmHg after 8 weeks; Blood pressure <140/90 after 8 weeks
- Secondary Outcome Measures
Name Time Method