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NCT01890135 · ClinicalTrials.gov registry record · Phase 2

Zibotentan, an Endothelin Receptor Antagonist, Patients With Intermittent Claudication

A Phase 2 study, sponsored by University of Virginia.

Completed
Registry status
Phase 2
Development phase
31
Enrollment target

NCT01890135 is a Phase 2 study that has completed, run by University of Virginia. The registered enrollment target is 31 participants.

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The verdict

NCT01890135, a Phase 2 study, has completed, sponsored by University of Virginia.

COMPLETED
Registry status
Phase 2
Development phase
31 participants
Enrollment target

Study Summary

Peripheral artery disease (PAD) is a major complication of atherosclerosis when blockages in the arteries to leg reduce blood flow and one of the resulting problems is termed intermittent claudication (IC). IC is leg pain with walking that is relieved with rest and IC is the most frequent clinical manifestation of PAD and it effects millions of Americans. The number of patients with, and the health care costs of, PAD will increase as the prevalence of PAD is associated with advancing age, diabetes, and smoking. Zibotentan (ZD4054) is an endothelin receptor A (ETA) blocker that undergone extensive human testing and has been shown to be safe in several patient population. There is ample evidence to suggest that an ETA blocker could improve blood flow to the legs in patients with PAD. In a study that will be funded by the National Institute of Health, the investigators will test the ability of this medication to allow better blood flow to the legs of patients with PAD. In patients with IC, the investigators will test the ability of ZD4054 to improve leg blood flow using a non-invasive imaging technique. In parallel the study will test for the ability of patients with leg pain to walk further and feel better.

Interventions

  • DRUG placebo
  • DRUG Zibotentan (ZD4054)

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2013-06
Est. Completion 2016-06
Phase Phase 2

Sponsor

University of Virginia

449 total trials

What the Registry Record Tells You About NCT01890135

The ClinicalTrials.gov registry entry for NCT01890135 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.

NCT01890135 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01890135 about?

NCT01890135 is a clinical study titled "Zibotentan, an Endothelin Receptor Antagonist, Patients With Intermittent Claudication". Peripheral artery disease (PAD) is a major complication of atherosclerosis when blockages in the arteries to leg reduce blood flow and one of the resulting problems is termed intermittent claudication (IC). IC is leg pain with walking that is relieved with rest and IC is the most frequent clinical m...

What is the current status of trial NCT01890135?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2013-06. Estimated completion is 2016-06.

What interventions are being tested in trial NCT01890135?

The interventions under investigation include: placebo (DRUG), Zibotentan (ZD4054) (DRUG).

Who is sponsoring clinical trial NCT01890135?

This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.