Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01243411 · ClinicalTrials.gov registry record · Phase 3
A Study of AA4500 in Men With Peyronie's Disease
A Phase 3 study, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 348
- Enrollment target
NCT01243411: Completed Phase 3 study, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
NCT01243411 is a Phase 3 study that has completed, run by Endo USA Inc., a Keenova Therapeutics Company. The registered enrollment target is 348 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01243411, a Phase 3 study, has completed, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 348 participants
- Enrollment target
Study Summary
This study is a Phase 3, open-label study of the safety and efficacy of AA4500 0.58 mg in subjects with Peyronie's disease. Subjects will be screened for study eligibility within 21 days before the initial injection of study drug in the first treatment cycle. After up to four treatment cycles, each subject will be followed for additional safety and efficacy assessments on Days 168 (± 7 days) and 252 (± 7 days) (nominal weeks 24 and 36). After the final injection of each treatment cycle, the investigator will model the plaque in an attempt to stretch or elongate the plaque. If the subject's penile curvature is reduced to \<15° after the first, second, or third cycle of injections or if the investigator determines further treatment is not clinically indicated (eg, adverse events; allergic reaction), subsequent treatment cycles will not be administered. Approximately 300 subjects will be enrolled.
Interventions
- BIOLOGICAL AA4500
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 348 participants |
| Start Date | 2010-11 |
| Est. Completion | 2012-08 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01243411
The ClinicalTrials.gov registry entry for NCT01243411 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 348 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Endo USA Inc., a Keenova Therapeutics Company, which has 61 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which AA4500 is the first listed.
NCT01243411 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01243411 about?
NCT01243411 is a clinical study titled "A Study of AA4500 in Men With Peyronie's Disease". This study is a Phase 3, open-label study of the safety and efficacy of AA4500 0.58 mg in subjects with Peyronie's disease. Subjects will be screened for study eligibility within 21 days before the initial injection of study drug in the first treatment cycle. After up to four treatment cycles, each...
What is the current status of trial NCT01243411?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 348 participants. The study started on 2010-11. Estimated completion is 2012-08.
What interventions are being tested in trial NCT01243411?
The interventions under investigation include: AA4500 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01243411?
This trial is sponsored by Endo USA Inc., a Keenova Therapeutics Company, which has 61 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
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, the data changelog, or report a data error.