Effect of the Direct Renin Inhibitor Aliskiren on Endothelial Function and Arterial Stiffness in Diabetic Subjects
Primary Purpose
Diabetes, Pre-hypertension, Hypertension
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
aliskiren 300 mg once daily
Placebo/sugar pill
Sponsored by
About this trial
This is an interventional health services research trial for Diabetes focused on measuring aliskiren, endothelial function, hypertension
Eligibility Criteria
Inclusion Criteria:
- Type 2 diabetes
- prehypertension or Stage 1 hypertension
Exclusion Criteria:
- Type 1 diabetes
- Stage 2 hypertension
- CKD
- recent MI, revascularization, CVA or TIA
Sites / Locations
- UAB
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
aliskiren 300 mg once daily for 12 weeks
Sugar pill/ placebo
Arm Description
aliskiren 300 mg daily
Patients were double-blind placebo-controlled randomized to either aliskiren 300 mg once daily or sugar pill/ placebo
Outcomes
Primary Outcome Measures
Change in Flow-mediated Dilation
Flow-mediated dilation of the brachial artery assessed by ultrasound to evaluate improvement of arterial functioning by % of dilation after non-invasive occlusion
Secondary Outcome Measures
Mean Central Aortic Pressure at 3 Months
Baseline to 3 months after Aliskiren/PLC, reported value at 3 months after start of study of central aortic pressure assessed by non-invasive applanation tonometry ( SphygmoCor, Atcor)
Full Information
NCT ID
NCT01349114
First Posted
May 4, 2011
Last Updated
April 5, 2017
Sponsor
University of Alabama at Birmingham
Collaborators
Novartis
1. Study Identification
Unique Protocol Identification Number
NCT01349114
Brief Title
Effect of the Direct Renin Inhibitor Aliskiren on Endothelial Function and Arterial Stiffness in Diabetic Subjects
Official Title
Effect of the Direct Renin Inhibitor Aliskiren on Endothelial Function and Arterial Stiffness in Diabetic Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Sponsor requested termination.
Study Start Date
June 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Novartis
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study will evaluate the effects of the direct renin inhibitor, aliskiren, on flow-mediated dilation of the brachial artery and on central aortic pressure in diabetic patients with pre-hypertension or Stage 1 hypertension.
Detailed Description
Patients are double-blind placebo-controlled randomized to either aliskiren or sugar pill/placebo. Effects on blood parameters and arteries are evaluated in both groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Pre-hypertension, Hypertension
Keywords
aliskiren, endothelial function, hypertension
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
aliskiren 300 mg once daily for 12 weeks
Arm Type
Active Comparator
Arm Description
aliskiren 300 mg daily
Arm Title
Sugar pill/ placebo
Arm Type
Placebo Comparator
Arm Description
Patients were double-blind placebo-controlled randomized to either aliskiren 300 mg once daily or sugar pill/ placebo
Intervention Type
Drug
Intervention Name(s)
aliskiren 300 mg once daily
Other Intervention Name(s)
Tekturna
Intervention Description
aliskiren 300 mg daily
Intervention Type
Drug
Intervention Name(s)
Placebo/sugar pill
Intervention Description
Sugar pill/placebo
Primary Outcome Measure Information:
Title
Change in Flow-mediated Dilation
Description
Flow-mediated dilation of the brachial artery assessed by ultrasound to evaluate improvement of arterial functioning by % of dilation after non-invasive occlusion
Time Frame
Baseline to 3 months
Secondary Outcome Measure Information:
Title
Mean Central Aortic Pressure at 3 Months
Description
Baseline to 3 months after Aliskiren/PLC, reported value at 3 months after start of study of central aortic pressure assessed by non-invasive applanation tonometry ( SphygmoCor, Atcor)
Time Frame
3 months after start of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 2 diabetes
prehypertension or Stage 1 hypertension
Exclusion Criteria:
Type 1 diabetes
Stage 2 hypertension
CKD
recent MI, revascularization, CVA or TIA
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A Calhoun, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAB
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of the Direct Renin Inhibitor Aliskiren on Endothelial Function and Arterial Stiffness in Diabetic Subjects
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