Back to resultsSPP100 (Aliskiren) Regimen in Hypertensive Patients With Renal Dysfunction
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, rennin
Eligibility Criteria
Inclusion Criteria: Age: 20 - 80 years old Gender: Male or female Status: Outpatients Elevated Serum Creatinine Exclusion Criteria: Patients suspected of malignant hypertension Patients with a clinically significant allergy Patients who have received other investigational drug Other protocol-defined inclusion/exclusion criteria may apply
Sites / Locations
- Novartis Pharmaceuticals
Outcomes
Primary Outcome Measures
Adverse events after 8 weeks
Secondary Outcome Measures
Change from baseline in mean sitting systolic blood pressure after 8 weeks
Change from baseline in mean sitting diastolic blood pressure after 8 weeks
Mean sitting systolic blood pressure is < 140 mmHg or a reduction of > 20 mmHg after 8 weeks
Mean sitting diastolic blood pressure is < 90 mmHg or a reduction of > 10 mmHg after 8 weeks
Blood pressure <140/90 after 8 weeks
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00299832
Brief Title
SPP100 (Aliskiren) Regimen in Hypertensive Patients With Renal Dysfunction
Official Title
A Multi-center, Open-label Study Assessing the Safety, Efficacy and Pharmacokinetics of 8 Week's Treatment of SPP100 (Aliskiren) Regimen in Hypertensive Patients With Renal Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Assessing the safety, efficacy and pharmacokinetics of SPP100 (Aliskiren) regimen in hypertensive patients with renal dysfunction
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, rennin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Aliskiren
Primary Outcome Measure Information:
Title
Adverse events after 8 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in mean sitting systolic blood pressure after 8 weeks
Title
Change from baseline in mean sitting diastolic blood pressure after 8 weeks
Title
Mean sitting systolic blood pressure is < 140 mmHg or a reduction of > 20 mmHg after 8 weeks
Title
Mean sitting diastolic blood pressure is < 90 mmHg or a reduction of > 10 mmHg after 8 weeks
Title
Blood pressure <140/90 after 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age: 20 - 80 years old
Gender: Male or female
Status: Outpatients
Elevated Serum Creatinine
Exclusion Criteria:
Patients suspected of malignant hypertension
Patients with a clinically significant allergy
Patients who have received other investigational drug Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Novartis
Official's Role
Study Chair
Facility Information:
Facility Name
Novartis Pharmaceuticals
City
Japan
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
19927154
Citation
Ito S, Nakura N, Le Breton S, Keefe D. Efficacy and safety of aliskiren in Japanese hypertensive patients with renal dysfunction. Hypertens Res. 2010 Jan;33(1):62-6. doi: 10.1038/hr.2009.175. Epub 2009 Nov 20.
Results Reference
result
Learn more about this trial
SPP100 (Aliskiren) Regimen in Hypertensive Patients With Renal Dysfunction
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