Efficacy and Safety of RAD001 in Patients Aged 18 and Over With Angiomyolipoma Associated With Either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM) — EXIST-2

Lymphangioleiomyomatosis (LAM) Clinical Trial

Official title:
A Randomized, Double-blind, Placebo-controlled Study of RAD0001 in the Treatment of Angiomyolipoma in Patients With Either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)

Status Completed

Clinical Trial Summary

This study will evaluate the safety and efficacy of RAD001 in treating patients with Angiomyolipoma associated with Tuberous Sclerosis Complex or Sporadic Lymphangioleiomyomatosis.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00790400
Study type	Interventional
Source	Novartis
Contact
Status	Completed
Phase	Phase 3
Start date	April 2009
Completion date	September 2015

View Details

See also
	Status	Clinical Trial	Phase
	Completed	`NCT04388371` - Glutamine PET Imaging in LAM	Phase 1
	Completed	`NCT02484664` - COLA: A Pilot Clinical Trial of COX-2 Inhibition in LAM and TSC	Phase 2