SPP100 (Aliskiren) Regimen in Patients With Severe Hypertension
Phase 3
Completed
- Conditions
- Hypertension
- Registration Number
- NCT00299806
- Lead Sponsor
- Novartis
- Brief Summary
Assessing the safety and efficacy of SPP100 (Aliskiren) regimen in patients with severe hypertension
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Incidence of adverse events after 8 weeks
- Secondary Outcome Measures
Name Time Method Change from baseline in mean sitting systolic and diastolic blood pressure after 8 weeks Average sitting diastolic blood pressure < 90 mmHg or a reduction from baseline of > 10 mmHg 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
Trial Locations
- Locations (1)
Novartis Pharmaceuticals
🇯🇵Japan, Japan