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Effect of the Direct Renin Inhibitor Aliskiren on Endothelial Function and Arterial Stiffness in Diabetic Subjects

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ClinicalTrials.gov Identifier: NCT01349114
Recruitment Status : Terminated (Sponsor requested termination.)
First Posted : May 6, 2011
Results First Posted : June 30, 2014
Last Update Posted : May 11, 2017
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
David Calhoun, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Diabetes Pre-hypertension Hypertension Drug: aliskiren 300 mg once daily Drug: Placebo/sugar pill Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Official Title: Effect of the Direct Renin Inhibitor Aliskiren on Endothelial Function and Arterial Stiffness in Diabetic Subjects
Study Start Date : June 2011
Primary Completion Date : January 2012
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Aliskiren
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: aliskiren 300 mg once daily for 12 weeks
aliskiren 300 mg daily
Drug: aliskiren 300 mg once daily
aliskiren 300 mg daily
Other Name: Tekturna
Placebo Comparator: Sugar pill/ placebo
Patients were double-blind placebo-controlled randomized to either aliskiren 300 mg once daily or sugar pill/ placebo
Drug: Placebo/sugar pill
Sugar pill/placebo



Primary Outcome Measures :
  1. Change in Flow-mediated Dilation [ Time Frame: Baseline to 3 months ]
    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 :
  1. Mean Central Aortic Pressure at 3 Months [ Time Frame: 3 months after start of study ]
    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)



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01349114


Locations
United States, Alabama
UAB
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Novartis
Investigators
Principal Investigator: David A Calhoun, MD University of Alabama at Birmingham

Responsible Party: David Calhoun, Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01349114     History of Changes
Other Study ID Numbers: F110124007
First Posted: May 6, 2011    Key Record Dates
Results First Posted: June 30, 2014
Last Update Posted: May 11, 2017
Last Verified: April 2017

Keywords provided by David Calhoun, University of Alabama at Birmingham:
aliskiren
endothelial function
hypertension

Additional relevant MeSH terms:
Hypertension
Prehypertension
Vascular Diseases
Cardiovascular Diseases