CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 118 enrolled
Drug / intervention
Everolimus (RAD001) +1 moredrug
Likely dose
Everolimus (RAD001) 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00790400
NCT00790400Phase 3Completed
CompareCT.gov

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)

Novartis Pharmaceuticals·interventional·Posted Nov 13, 2008·Updated Feb 17, 2017

In Brief

A Phase 3 clinical trial evaluating Everolimus (RAD001) and Everolimus Placebo for Tuberous Sclerosis Complex (TSC) and Lymphangioleiomyomatosis (LAM). Completed, enrolled 118 participants across 25 sites in 11 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberous Sclerosis Complex (TSC), Lymphangioleiomyomatosis (LAM)
CountriesCanada, France, Germany, Italy, Japan, Netherlands, Poland, Russia, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 13, 2008
Enrollment StartApr 1, 2009
Primary CompletionJun 1, 2011
Study CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 17.6 years ago

Interventions

Everolimus (RAD001)drug

Everolimus is used in 5 mg strength tablets, blister-packed under aluminum foil in units of ten tablets and dosed on a daily basis. 10mg daily dosing throughout the trial.

Everolimus Placebodrug

Matching placebo was provided as a matching tablet and was also blister-packed under aluminum foil in units of ten.