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NCT02061397 · ClinicalTrials.gov registry record · Phase 1
Safety of Simvastatin in LAM and TSC
A Phase 1 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT02061397: Completed Phase 1 study, sponsored by University of Pennsylvania.
NCT02061397 is a Phase 1 study that has completed, run by University of Pennsylvania. The registered enrollment target is 10 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02061397, a Phase 1 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
The purpose of this research study is to see if simvastatin can be taken safely in patients with either LAM or TSC, who are already being treated with everolimus or sirolimus. This is the first step in looking at simvastatin as a drug that may help patients, by impacting the growth and survival of cells that make up the lung lesions that cause problems in LAM and TSC patients. The study also seeks to learn more about how simvastatin works, when given to patients being treated with everolimus or sirolimus, and to evaluate the safety and any potential benefit to patients taking this 2-drug combination. The primary objective of this study is to determine the safety of simvastatin in the treatment of LAM-S or LAM-TS in patients on a stable (for at least 3 months) dose of sirolimus or everolimus. Secondary objectives include: * To assess the effect of simvastatin on forced expiratory volume in 1 second (FEV1). * To assess the effect of simvastatin on forced vital capacity (FVC). * To assess the effect of simvastatin on diffusing lung capacity (DLCO). * To assess the effect of simvastatin on vascular endothelial growth factor -D (VEGF-D) serum levels. * To assess the effect of simvastatin with questionnaire- based assessments of dyspnea, fatigue, and quality of life (QOL). * Assess signs of clinical benefit.
Interventions
- DRUG Simvastatin
- DRUG Sirolimus Oral Product
- DRUG Everolimus Oral Product
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2014-03 |
| Est. Completion | 2019-12-13 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02061397
The ClinicalTrials.gov registry entry for NCT02061397 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Simvastatin is the first listed.
NCT02061397 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02061397 about?
NCT02061397 is a clinical study titled "Safety of Simvastatin in LAM and TSC". The purpose of this research study is to see if simvastatin can be taken safely in patients with either LAM or TSC, who are already being treated with everolimus or sirolimus. This is the first step in looking at simvastatin as a drug that may help patients, by impacting the growth and survival of c...
What is the current status of trial NCT02061397?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2014-03. Estimated completion is 2019-12-13.
What interventions are being tested in trial NCT02061397?
The interventions under investigation include: Simvastatin (DRUG), Sirolimus Oral Product (DRUG), Everolimus Oral Product (DRUG).
Who is sponsoring clinical trial NCT02061397?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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