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NCT04794530 · ClinicalTrials.gov registry record · Phase 3
The COCOA-PAD II Trial
A Phase 3 study of Peripheral Artery Disease, sponsored by Northwestern University.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 190
- Enrollment target
- 3
- Study locations
NCT04794530 is a Phase 3 study of Peripheral Artery Disease that is actively recruiting participants, run by Northwestern University. The registered enrollment target is 190 participants, above the 123-participant average among 50 other Peripheral Artery Disease trials with a reported enrollment target (54% higher). The trial reports 3 study locations across 2 states.
The verdict
NCT04794530, a Phase 3 study of Peripheral Artery Disease, is actively recruiting participants, sponsored by Northwestern University.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 190 participants
- Enrollment target
- 3
- Study locations
Study Summary
Among people with peripheral artery disease (PAD) age 55 and older, the investigators will test the hypothesis that PAD participants randomized to cocoa flavanols will have greater improvement or less decline in six-minute walk distance at six-month follow-up, compared to those randomized to placebo. The study will randomize 190 participants with PAD age 55 and older to one of two groups for six months: cocoa flavanols vs placebo. Our primary outcome is change in six-minute walk distance at six-month follow-up. Secondary outcomes are Actigraph-measured physical activity, brachial artery flow-mediated dilation (FMD), gastrocnemius muscle biopsy measures of endothelial nitric oxide synthase (eNOS) and phosphorylated eNOS, gastrocnemius muscle perfusion (measured by magnetic resonance imaging (MRI)) and gastrocnemius muscle characteristics (measured by muscle biopsy). To achieve the specific aims, the study will randomize 190 participants age 55 and older with PAD to one of two groups: cocoa flavanols vs placebo. Participants will be followed for six months.
Conditions Studied
Interventions
- DRUG placebo
- DRUG cocoa flavanols
Study Locations (3)
Illinois
- Northwestern University - Chicago
- University of Chicago - Chicago
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 190 participants |
| Start Date | 2021-11-19 |
| Est. Completion | 2027-01-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04794530
The ClinicalTrials.gov registry entry for NCT04794530 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 190 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 123-participant average among 50 other Peripheral Artery Disease trials with a reported enrollment target (54% higher). The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Peripheral Artery Disease appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT04794530 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Illinois, Minnesota.
Frequently Asked Questions
What is clinical trial NCT04794530 about?
NCT04794530 is a clinical study titled "The COCOA-PAD II Trial". Among people with peripheral artery disease (PAD) age 55 and older, the investigators will test the hypothesis that PAD participants randomized to cocoa flavanols will have greater improvement or less decline in six-minute walk distance at six-month follow-up, compared to those randomized to placebo...
What is the current status of trial NCT04794530?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 190 participants. The study started on 2021-11-19. Estimated completion is 2027-01-31.
What conditions does trial NCT04794530 study?
This clinical trial studies the following conditions: Peripheral Artery Disease.
What interventions are being tested in trial NCT04794530?
The interventions under investigation include: placebo (DRUG), cocoa flavanols (DRUG).
Who is sponsoring clinical trial NCT04794530?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04794530 being conducted?
This trial has 3 study locations across Illinois, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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.