Study Stopped
Sponsor requested termination.
Effect of the Direct Renin Inhibitor Aliskiren on Endothelial Function and Arterial Stiffness in Diabetic Subjects
1 other identifier
interventional
21
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 diabetes
Started Jun 2011
Shorter than P25 for phase_4 diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2011
CompletedFirst Posted
Study publicly available on registry
May 6, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedResults Posted
Study results publicly available
June 30, 2014
CompletedMay 11, 2017
April 1, 2017
7 months
May 4, 2011
July 11, 2013
April 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Baseline to 3 months
Secondary Outcomes (1)
Mean Central Aortic Pressure at 3 Months
3 months after start of study
Study Arms (2)
aliskiren 300 mg once daily for 12 weeks
ACTIVE COMPARATORaliskiren 300 mg daily
Sugar pill/ placebo
PLACEBO COMPARATORPatients were double-blind placebo-controlled randomized to either aliskiren 300 mg once daily or sugar pill/ placebo
Interventions
aliskiren 300 mg daily
Eligibility Criteria
You may qualify if:
- Type 2 diabetes
- prehypertension or Stage 1 hypertension
You may not qualify if:
- Type 1 diabetes
- Stage 2 hypertension
- CKD
- recent MI, revascularization, CVA or TIA
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Alabama at Birminghamlead
- Novartiscollaborator
Study Sites (1)
UAB
Birmingham, Alabama, 35294, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Early termination leading to smaller number of subjects analyzed then anticipated, no adverse effects within the aliskiren group
Results Point of Contact
- Title
- David A. Calhoun, MD
- Organization
- University of Alabama at Birmingham
Study Officials
- PRINCIPAL INVESTIGATOR
David A Calhoun, MD
University of Alabama at Birmingham
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 4, 2011
First Posted
May 6, 2011
Study Start
June 1, 2011
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
May 11, 2017
Results First Posted
June 30, 2014
Record last verified: 2017-04