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NCT01349114 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study, sponsored by University of Alabama at Birmingham.

Terminated
Registry status
Phase 4
Development phase
21
Enrollment target

NCT01349114: Clinical Trial Phase 4 study, sponsored by University of Alabama at Birmingham.

NCT01349114 is a Phase 4 study that was terminated before completion, run by University of Alabama at Birmingham. The registered enrollment target is 21 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01349114, a Phase 4 study, was terminated before completion, sponsored by University of Alabama at Birmingham.

TERMINATED
Registry status
Phase 4
Development phase
21 participants
Enrollment target

Study 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.

Primary Outcome

Flow-mediated dilation of the brachial artery assessed by ultrasound to evaluate improvement of arterial functioning by % of dilation after non-invasive occlusion

Interventions

  • DRUG aliskiren 300 mg once daily
  • DRUG Placebo/sugar pill

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2011-06
Est. Completion 2012-01
Phase Phase 4
University of Alabama at Birmingham

1,160 total trials

Why NCT01349114 stopped before completion

NCT01349114 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 2 interventions - of which aliskiren 300 mg once daily is the first listed.

NCT01349114 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01349114 about?

NCT01349114 is a clinical study titled "Effect of the Direct Renin Inhibitor Aliskiren on Endothelial Function and Arterial Stiffness in Diabetic Subjects". 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.

What is the current status of trial NCT01349114?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 21 participants. The study started on 2011-06. Estimated completion is 2012-01.

What interventions are being tested in trial NCT01349114?

The interventions under investigation include: aliskiren 300 mg once daily (DRUG), Placebo/sugar pill (DRUG).

Who is sponsoring clinical trial NCT01349114?

This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01349114's enrollment target sits among peer trials

21 1742nd of 2000 higher than 248 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01349114, the US trial registry maintained by the National Library of Medicine. NCT01349114 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.