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NCT02842424 · ClinicalTrials.gov registry record · Phase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
A Phase 4 study of Peripheral Arterial Disease, sponsored by University of Nebraska.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT02842424 is a Phase 4 study of Peripheral Arterial Disease that is actively recruiting participants, run by University of Nebraska. The registered enrollment target is 70 participants, below the 4,205-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02842424, a Phase 4 study of Peripheral Arterial Disease, is actively recruiting participants, sponsored by University of Nebraska.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study Summary
Peripheral artery disease (PAD) is a manifestation of atherosclerosis that produces progressive narrowing and occlusion of the arteries supplying the lower extremities. The most common clinical manifestation of PAD is claudication, i.e., a severe functional limitation identified as gait dysfunction and walking-induced leg muscle pain relieved by rest. The standard therapies for claudication include the medications cilostazol and pentoxifylline, supervised exercise therapy and operative revascularization. Recent data demonstrated that 24 weeks of treatment with the angiotensin-converting enzyme (ACE) inhibitor Ramipril produces improvements in the walking performance of patients with claudication that are higher than those of cilostazol and pentoxifylline and similar to those produced by supervised exercise therapy and operative revascularization. The mechanisms by which Ramipril therapy produces this impressive improvement in the functional capacity of claudicating patients remain unknown. The Investigators hypothesize that treatment of claudicating PAD patients with Ramipril will improve walking performance and quality of life by improving the myopathy of the gastrocnemius. Improved myopathy is a consequence of reduced oxidative damage, reduced TGF-β1 production by vascular smooth muscle cells and reduced collagen deposition in the affected gastrocnemius.
Conditions Studied
Interventions
- DRUG Ramipril
Study Locations (1)
Nebraska
- VA Medical Center - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2016-02-25 |
| Est. Completion | 2026-06 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02842424
The ClinicalTrials.gov registry entry for NCT02842424 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,205-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (98% lower). The listed sponsor is University of Nebraska, which has 407 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 1 intervention - of which Ramipril is the first listed.
NCT02842424 reports 1 study location spanning 1 distinct geographic area - top geographies include Nebraska.
Frequently Asked Questions
What is clinical trial NCT02842424 about?
NCT02842424 is a clinical study titled "Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis". Peripheral artery disease (PAD) is a manifestation of atherosclerosis that produces progressive narrowing and occlusion of the arteries supplying the lower extremities. The most common clinical manifestation of PAD is claudication, i.e., a severe functional limitation identified as gait dysfunction ...
What is the current status of trial NCT02842424?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 70 participants. The study started on 2016-02-25. Estimated completion is 2026-06.
What conditions does trial NCT02842424 study?
This clinical trial studies the following conditions: Peripheral Arterial Disease.
What interventions are being tested in trial NCT02842424?
The interventions under investigation include: Ramipril (DRUG).
Who is sponsoring clinical trial NCT02842424?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02842424 being conducted?
This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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