Trial · NCT02061397
Safety of Simvastatin in LAM and TSC
NCT02061397, Phase 1, Phase 2, Completed, University of Pennsylvania; results first posted 2020-08-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety of Simvastatin in LAM and TSC. Trials, record NCT02061397. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02061397
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety of Simvastatin in LAM and TSC
- NCT number
- NCT02061397
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- University of Pennsylvania
- Conditions
- Lymphangioleiomyomatosis, Tuberous Sclerosis Complex
- Interventions
- Simvastatin, Sirolimus Oral Product, Everolimus Oral Product
- First posted
- 2014-02-12
- Last updated
- 2020-08-25
- Results first posted
- 2020-08-25
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety of Simvastatin in the Treatment of LAM-S and LAM-TS Patients | 5 months | Safety is a primary outcome measure which will be assessed by any major changes or deterioration in patient health. |
| Secondary | Percent Predicted FEV1 | 5 months | Lung function will be measured by FEV1: forced expiratory volume in 1s mean and calculated as % predicted +\_ SD (standard deviation). |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Safety of Simvastatin in the Treatment of LAM-S and LAM-TS Patients | 5 months | participants | NUMBER | |
| SECONDARY | Percent Predicted FEV1 | 5 months | percent predicted FEV1 | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety of Simvastatin in the Treatment of LAM-S and LAM-TS Patients | Single Simvastatin Treatment Arm | 0 | participants | ||
| Percent Predicted FEV1 | Single Simvastatin Treatment Arm | -2.9 | Standard Deviation 3.7 | percent predicted FEV1 |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Simvastatin 20 mg Oral Daily for 2 Month | STARTED | Single Simvastatin Treatment Arm | 10 | |
| Simvastatin 20 mg Oral Daily for 2 Month | COMPLETED | Single Simvastatin Treatment Arm | 10 | |
| Simvastatin 20 mg Oral Daily for 2 Month | NOT COMPLETED | Single Simvastatin Treatment Arm | 0 | |
| Simvastatin 40 mg Oral Daily for 2 Month | STARTED | Single Simvastatin Treatment Arm | 10 | |
| Simvastatin 40 mg Oral Daily for 2 Month | COMPLETED | Single Simvastatin Treatment Arm | 10 | |
| Simvastatin 40 mg Oral Daily for 2 Month | NOT COMPLETED | Single Simvastatin Treatment Arm | 0 |
Source ClinicalTrials.gov
Adverse events3
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Tachycardia | Cardiac disorders | Single Simvastatin Treatment Arm | 1 | 10 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Single Simvastatin Treatment Arm | 1 | 10 | 1 |
| other | Peripheral adema | Blood and lymphatic system disorders | Single Simvastatin Treatment Arm | 1 | 10 | 4 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Single Simvastatin Treatment Arm | 0 | 10 |
| Total, other adverse events | Single Simvastatin Treatment Arm | 3 | 10 |
| Total, serious adverse events | Single Simvastatin Treatment Arm | 0 | 10 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02061397
GET https://conductscience.org/api/trials/v1/NCT02061397/registered