Study Comparing SPP100 (Aliskiren) 150mg to Placebo and to Losartan 50mg in Patients With Mild to Moderate Essential Hypertension
Information source: Novartis
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Aliskiren (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Japan, Study Chair, Affiliation: Novartis Pharmaceuticals, Japan
Summary
Assessing efficacy, safety and pharmacokinetics in patients with mild to moderate essential
hypertension
Clinical Details
Official title: 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
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Mean sitting diastolic blood pressure (msDBP) lowering from baseline to the study end to placebo and losartan
Secondary outcome: Mean sitting systolic pressure (msSBP) lowering from baseline to the study end to placebo and losartanSuccessful response; msDBP <90mmHg and/or a reduction of msDBP ≥ 10mmHg Control rate; msDBP <90mmHg and msSBP<140mmHg The pharmacokinetics / pharmacodynamics Safety and tolerability
Eligibility
Minimum age: 20 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Novartis Pharmaceuticals, Japan, Japan
Additional Information
Starting date: June 2006
Last updated: December 21, 2007
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