SPP100 (Aliskiren) Regimen in Hypertensive Patients With Renal Dysfunction
Phase 3
Completed
- Conditions
- Hypertension
- Registration Number
- NCT00299832
- Lead Sponsor
- Novartis
- Brief Summary
Assessing the safety, efficacy and pharmacokinetics of SPP100 (Aliskiren) regimen in hypertensive patients with renal dysfunction
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Adverse events after 8 weeks
- Secondary Outcome Measures
Name Time Method Change from baseline in mean sitting diastolic blood pressure after 8 weeks Change from baseline in mean sitting systolic blood pressure after 8 weeks Mean sitting diastolic blood pressure is < 90 mmHg or a reduction of > 10 mmHg after 8 weeks Mean sitting systolic blood pressure is < 140 mmHg or a reduction of > 20 mmHg after 8 weeks Blood pressure <140/90 after 8 weeks
Trial Locations
- Locations (1)
Novartis Pharmaceuticals
🇯🇵Japan, Japan