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

April 5, 2017 updated by: David Calhoun, University of Alabama at Birmingham
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

21

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • UAB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3 months after start of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

May 4, 2011

First Submitted That Met QC Criteria

May 5, 2011

First Posted (ESTIMATE)

May 6, 2011

Study Record Updates

Last Update Posted (ACTUAL)

May 11, 2017

Last Update Submitted That Met QC Criteria

April 5, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F110124007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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