Text Size

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

This study has been terminated.
(Sponsor requested termination.)
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
David Calhoun, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01349114
First received: May 4, 2011
Last updated: February 16, 2012
Last verified: February 2012
History of Changes
  Purpose

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 Intervention Phase
Diabetes
Pre-hypertension
Hypertension
 Drug: aliskiren
Drug: placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Health Services Research
Official Title: Effect of the Direct Renin Inhibitor Aliskiren on Endothelial Function and Arterial Stiffness in Diabetic Subjects

Resource links provided by NLM:

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

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Change in FMD [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Flow-mediated dilation of the brachial artery


Secondary Outcome Measures:
  • Change in central aortic pressure [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: June 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: aliskiren
aliskiren 300 mg daily
 Drug: aliskiren
aliskiren 300 mg daily
Placebo Comparator: placebo Drug: placebo
placebo

  Eligibility

Ages Eligible for Study:   19 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: David Calhoun, Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01349114     History of Changes
Other Study ID Numbers: F110124007
Study First Received: May 4, 2011
Last Updated: February 16, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Hypertension
Prehypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013