Back to resultsStudy Comparing SPP100 (Aliskiren) 150mg to Placebo and to Losartan 50mg in Patients With Mild to Moderate Essential Hypertension
Primary Purpose
Hypertension
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Aliskiren
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Hypertension, aliskiren, blood pressure, renin
Eligibility 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
Sites / Locations
- Novartis Pharmaceuticals
Outcomes
Primary Outcome Measures
Mean sitting diastolic blood pressure (msDBP) lowering from baseline to the study end to placebo and losartan
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00344110
Brief Title
Study Comparing SPP100 (Aliskiren) 150mg to Placebo and to Losartan 50mg in Patients With Mild to Moderate Essential Hypertension
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 Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
Assessing efficacy, safety and pharmacokinetics in patients with mild to moderate essential hypertension
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Hypertension, aliskiren, blood pressure, renin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
768 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Aliskiren
Primary Outcome Measure Information:
Title
Mean sitting diastolic blood pressure (msDBP) lowering from baseline to the study end to placebo and losartan
Secondary Outcome Measure Information:
Title
Mean sitting systolic pressure (msSBP) lowering from baseline to the study end to placebo and losartan
Title
Successful response; msDBP <90mmHg and/or a reduction of msDBP ≥ 10mmHg
Title
Control rate; msDBP <90mmHg and msSBP<140mmHg
Title
The pharmacokinetics / pharmacodynamics
Title
Safety and tolerability
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals, Japan
Organizational Affiliation
Novartis Pharmaceuticals, Japan
Official's Role
Study Chair
Facility Information:
Facility Name
Novartis Pharmaceuticals
City
Japan
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Study Comparing SPP100 (Aliskiren) 150mg to Placebo and to Losartan 50mg in Patients With Mild to Moderate Essential Hypertension
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