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NCT01756833 · ClinicalTrials.gov registry record · Phase 2
Non-Invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial
A Phase 2 study of Aneurysm, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- Phase 2
- Development phase
- 261
- Enrollment target
- 20
- Study locations
NCT01756833: Completed Phase 2 study of Aneurysm, sponsored by University of Maryland, Baltimore.
NCT01756833 is a Phase 2 study of Aneurysm that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 261 participants, below the 17,053-participant average among 6 other Aneurysm trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01756833, a Phase 2 study of Aneurysm, has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 261 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary aim of this study is to determine if doxycycline (100 mg bid) will inhibit (by at least 40%) the increase in greatest transverse diameter of small abdominal aortic aneurysms (3.5-5.0 cm in men, 3.5-4.5 cm in women) over a 24-month period of observation in comparison to a placebo-treated control group.
Primary Outcome
Diameters were ranked from smallest to largest. Worse ranks were assigned to surviving patients who underwent aneurysm repair (in order of longest to shortest time from randomization to repair), and worst ranks were assigned to patients who died (in order likewise). Each rank was converted to a z-score corresponding to the value on the standard normal curve of its percentile. The primary analysis was based on linear regression of the change in z-scores from baseline to 2 years. Independent varia
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Doxycycline
Study Locations (20)
Arizona
- University of Arizona Medical Center - Tucson
- Carondelet Heart & Vascular Institute - Tucson
California
- University of Southern California - Los Angeles
- Stanford University - Stanford
Florida
- Miami Cardiac and Vascular Institute - Miami
- University of South Florida Health Center - Tampa
Michigan
- University of Michigan Medical Center - Ann Arbor
- McLaren Northern Michigan - Petoskey
Nebraska
- Omaha VAMC - Omaha
- University of Nebraska Medical Center - Omaha
Oregon
- Oregon Health Sciences University - Portland
- Portland VAMC - Portland
Illinois
- Northwestern University Memorial Hospital - Chicago
Maryland
- University of Maryland Medical Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 261 participants |
| Start Date | 2013-05 |
| Est. Completion | 2019-07-23 |
| Phase | Phase 2 |
What the finished NCT01756833 record still lists
NCT01756833 is an interventional study that assigns participants to a tested intervention. The registered 261 participants enrollment target is mid-sized for trials with a published cap, below the 17,053-participant average among 6 other Aneurysm trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Aneurysm appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01756833 names 20 study sites across 14 states, led by Arizona, California, Florida.
Frequently Asked Questions
What is clinical trial NCT01756833 about?
NCT01756833 is a clinical study titled "Non-Invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial". The primary aim of this study is to determine if doxycycline (100 mg bid) will inhibit (by at least 40%) the increase in greatest transverse diameter of small abdominal aortic aneurysms (3.5-5.0 cm in men, 3.5-4.5 cm in women) over a 24-month period of observation in comparison to a placebo-treated ...
What is the current status of trial NCT01756833?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 261 participants. The study started on 2013-05. Estimated completion is 2019-07-23.
What conditions does trial NCT01756833 study?
This clinical trial studies the following conditions: Aneurysm.
What interventions are being tested in trial NCT01756833?
The interventions under investigation include: Placebo (DRUG), Doxycycline (DRUG).
Who is sponsoring clinical trial NCT01756833?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01756833 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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