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: July 15, 2014
Last verified: July 2014
  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 300 mg once daily
Drug: Placebo/sugar pill
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:


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

Primary Outcome Measures:
  • Change in Flow-mediated Dilation [ Time Frame: Baseline to 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months after start of study ] [ Designated as safety issue: No ]
    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)


Enrollment: 21
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
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

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: July 11, 2013
Last Updated: July 15, 2014
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 September 15, 2014