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

NCT ID: NCT01349114

Last Updated: 2017-05-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetes Pre-hypertension Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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aliskiren 300 mg once daily for 12 weeks

aliskiren 300 mg daily

Group Type ACTIVE_COMPARATOR

aliskiren 300 mg once daily

Intervention Type DRUG

aliskiren 300 mg daily

Sugar pill/ placebo

Patients were double-blind placebo-controlled randomized to either aliskiren 300 mg once daily or sugar pill/ placebo

Group Type PLACEBO_COMPARATOR

Placebo/sugar pill

Intervention Type DRUG

Sugar pill/placebo

Interventions

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aliskiren 300 mg once daily

aliskiren 300 mg daily

Intervention Type DRUG

Placebo/sugar pill

Sugar pill/placebo

Intervention Type DRUG

Other Intervention Names

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Tekturna

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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David Calhoun

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David A Calhoun, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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UAB

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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F110124007

Identifier Type: -

Identifier Source: org_study_id

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