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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: Completed Phase 3 study, sponsored by University of Cincinnati.
NCT00414648 is a Phase 3 study that has completed, run by University of Cincinnati. The registered enrollment target is 89 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
FEV1 values reported are in liters or milliliters. There are no definite minimum and maximum values of FEV1 as it is a physiological measure of lung function and varies from individual to individual. Normative ranges are determined in populations stratified by gender, height, age and race/ethnicity. Higher FEV1 values indicate better lung function.
Interventions
- DRUG Sirolimus
- DRUG Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2006-12 |
| Est. Completion | 2011-02 |
| Phase | Phase 3 |
What the finished NCT00414648 record still lists
NCT00414648 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Sirolimus is the first listed.
NCT00414648 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00414648's enrollment target sits among peer trials
89 1738th of 2000 higher than 262 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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