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NCT00414648 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Sirolimus in LAM
A Phase 3 study, sponsored by University of Cincinnati.
- Completed
- Registry status
- Phase 3
- Development phase
- 89
- Enrollment target
NCT00414648 is a Phase 3 study that has completed, run by University of Cincinnati. The registered enrollment target is 89 participants.
The verdict
NCT00414648, a Phase 3 study, has completed, sponsored by University of Cincinnati.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 89 participants
- Enrollment target
Study Summary
Lymphangioleiomyomatosis (LAM) is a rare lung disease of women that is caused by genetic mutations. It results in the uncontrolled growth of an unusual type of smooth muscle cell in the lung. These cells invade lung tissue, including the airways, blood vessels, and lymph vessels, and restrict the flow of air, blood, and lymph, respectively. Respiratory failure, lung collapse (pneumothorax), and pleural effusions (chylothorax) are hallmarks of the disease. This study will evaluate the safety and effectiveness of sirolimus, an inhibitor of the mTOR pathway, in stabilizing or improving lung function in people with LAM.
Interventions
- DRUG Sirolimus
- DRUG Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2006-12 |
| Est. Completion | 2011-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00414648
The ClinicalTrials.gov registry entry for NCT00414648 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 89 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Cincinnati, which has 245 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sirolimus is the first listed.
NCT00414648 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00414648 about?
NCT00414648 is a clinical study titled "Efficacy and Safety of Sirolimus in LAM". Lymphangioleiomyomatosis (LAM) is a rare lung disease of women that is caused by genetic mutations. It results in the uncontrolled growth of an unusual type of smooth muscle cell in the lung. These cells invade lung tissue, including the airways, blood vessels, and lymph vessels, and restrict the fl...
What is the current status of trial NCT00414648?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 89 participants. The study started on 2006-12. Estimated completion is 2011-02.
What interventions are being tested in trial NCT00414648?
The interventions under investigation include: Sirolimus (DRUG), Placebo (DRUG).
Who is sponsoring clinical trial NCT00414648?
This trial is sponsored by University of Cincinnati, which has 245 total clinical trials registered on ClinicalTrials.gov.
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