Safety of Simvastatin in LAM and TSC

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

March 31, 2014

Primary Completion Date

December 13, 2019

Study Completion Date

December 13, 2019

Conditions
LymphangioleiomyomatosisTuberous Sclerosis Complex
Interventions
DRUG

Simvastatin

Eligible patients on sirolimus or everolimus will be assigned to receive 20 mg of simvastatin once daily for a period of two months. If tolerated, the dosage of simvastatin will be advanced to 40 mg once daily in months 3 and 4.

DRUG

Sirolimus Oral Product

Eligible patients on sirolimus will be assigned to receive 20 mg of simvastatin once daily for a period of two months. If tolerated, the dosage of simvastatin will be advanced to 40 mg once daily in months 3 and 4.

DRUG

Everolimus Oral Product

Eligible patients on everolimus will be assigned to receive 20 mg of simvastatin once daily for a period of two months. If tolerated, the dosage of simvastatin will be advanced to 40 mg once daily in months 3 and 4.

Trial Locations (1)

19104

University of Pennsylvania, Philadelphia

All Listed Sponsors
collaborator

The LAM Foundation

OTHER

lead

University of Pennsylvania

OTHER

NCT02061397 - Safety of Simvastatin in LAM and TSC | Biotech Hunter | Biotech Hunter