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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01349114
Other study ID # F110124007
Secondary ID
Status Terminated
Phase Phase 4
First received May 4, 2011
Last updated July 15, 2014
Start date June 2011
Est. completion date January 2012

Study information

Verified date July 2014
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 21
Est. completion date January 2012
Est. primary completion date January 2012
Accepts healthy volunteers No
Gender Both
Age group 19 Years to 80 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Drug:
aliskiren 300 mg once daily
aliskiren 300 mg daily
Placebo/sugar pill
Sugar pill/placebo

Locations

Country Name City State
United States UAB Birmingham Alabama

Sponsors (2)

Lead Sponsor Collaborator
University of Alabama at Birmingham Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Flow-mediated Dilation 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 No
Secondary Mean Central Aortic Pressure at 3 Months 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 No
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