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NCT01684930 · ClinicalTrials.gov registry record · Phase 2

Nitrites, Exercise, and Peripheral Arterial Disease

A Phase 2 study of Peripheral Arterial Disease, sponsored by Duke University.

Completed
Registry status
Phase 2
Development phase
32
Enrollment target
1
Study location

NCT01684930 is a Phase 2 study of Peripheral Arterial Disease that has completed, run by Duke University. The registered enrollment target is 32 participants, below the 4,206-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01684930, a Phase 2 study of Peripheral Arterial Disease, has completed, sponsored by Duke University.

COMPLETED
Registry status
Phase 2
Development phase
32 participants
Enrollment target
1
Study location

Study Summary

The hypothesis of this proposal is that in subjects with PAD, regular consumption of a high nitrate supplement which raises plasma nitrite, in conjunction with 12 weeks of supervised exercise training at the limb ischemic threshold (SET) will produce a greater clinical benefit (increases in COT and PWT) than placebo plus supervised exercise at the limb ischemic threshold (PET).

Interventions

  • DRUG Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training
  • OTHER Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training

Study Locations (1)

North Carolina

  • Duke Diet & Fitness Center - Durham

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2012-06
Est. Completion 2014-11
Phase Phase 2

Sponsor

Duke University

1,725 total trials

What the Registry Record Tells You About NCT01684930

The ClinicalTrials.gov registry entry for NCT01684930 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,206-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (99% lower). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Peripheral Arterial Disease appearing as the primary indexed condition, and to 2 interventions - of which Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training is the first listed.

NCT01684930 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.

Frequently Asked Questions

What is clinical trial NCT01684930 about?

NCT01684930 is a clinical study titled "Nitrites, Exercise, and Peripheral Arterial Disease". The hypothesis of this proposal is that in subjects with PAD, regular consumption of a high nitrate supplement which raises plasma nitrite, in conjunction with 12 weeks of supervised exercise training at the limb ischemic threshold (SET) will produce a greater clinical benefit (increases in COT and ...

What is the current status of trial NCT01684930?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2012-06. Estimated completion is 2014-11.

What conditions does trial NCT01684930 study?

This clinical trial studies the following conditions: Peripheral Arterial Disease.

What interventions are being tested in trial NCT01684930?

The interventions under investigation include: Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training (DRUG), Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training (OTHER).

Who is sponsoring clinical trial NCT01684930?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01684930 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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