Study Comparing SPP100 (Aliskiren) 150mg to Placebo and to Losartan 50mg in Patients With Mild to Moderate Essential Hypertension
Phase 3
Completed
- Conditions
- Hypertension
- Registration Number
- NCT00344110
- Lead Sponsor
- Novartis
- Brief Summary
Assessing efficacy, safety and pharmacokinetics in patients with mild to moderate essential hypertension
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 768
Inclusion Criteria
- Age: 20 - 75 years old
- Gender: Male or female
- Status: Outpatients
- Mild to moderate essential hypertension
Exclusion Criteria
- Pregnant women, lactating mothers, women suspected of being pregnant, or women who wish to be pregnant
- Patients with msSBP >==180 mmHg and/or msDBP >=110 mmHg at Visit 1, 2 or 3
- Patients with or suspected of having secondary hypertension (due to aortic coarctation, primary aldosteronism, etc.)
- Patients suspected of having malignant hypertension
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Mean sitting diastolic blood pressure (msDBP) lowering from baseline to the study end to placebo and losartan
- Secondary Outcome Measures
Name Time Method Mean sitting systolic pressure (msSBP) lowering from baseline to the study end to placebo and losartan Successful response; msDBP <90mmHg and/or a reduction of msDBP ≥ 10mmHg Control rate; msDBP <90mmHg and msSBP<140mmHg The pharmacokinetics / pharmacodynamics Safety and tolerability
Trial Locations
- Locations (1)
Novartis Pharmaceuticals
🇯🇵Japan, Japan