NCT00344110CompletedPhase 3
A Randomized, Double-blind, Placebo and Active-controlled, Multicenter, Parallel-group Study Comparing SPP100 (Aliskiren) 150mg to Placebo and to Losartan 50mg to Evaluate Efficacy, Safety and Pharmacokinetics in Patients With Mild to Moderate Essential Hypertension
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Novartis
- Enrollment
- 768
- Locations
- 1
- Primary Endpoint
- Mean sitting diastolic blood pressure (msDBP) lowering from baseline to the study end to placebo and losartan
Study Overview
Brief Summary
Assessing efficacy, safety and pharmacokinetics in patients with mild to moderate essential hypertension
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 20 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Mean sitting diastolic blood pressure (msDBP) lowering from baseline to the study end to placebo and losartan
Secondary Outcomes
- 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
Investigators
Study Sites (1)
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