Trials / Completed
CompletedNCT00790400
Efficacy and Safety of RAD001 in Patients Aged 18 and Over With Angiomyolipoma Associated With Either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)
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
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 118 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the safety and efficacy of RAD001 in treating patients with Angiomyolipoma associated with Tuberous Sclerosis Complex or Sporadic Lymphangioleiomyomatosis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Everolimus (RAD001) | 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. |
| DRUG | Everolimus Placebo | Matching placebo was provided as a matching tablet and was also blister-packed under aluminum foil in units of ten. |
Timeline
- Start date
- 2009-04-01
- Primary completion
- 2011-06-01
- Completion
- 2015-11-01
- First posted
- 2008-11-13
- Last updated
- 2017-02-17
- Results posted
- 2012-08-28
Locations
25 sites across 11 countries: United States, Canada, France, Germany, Italy, Japan, Netherlands, Poland, Russia, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT00790400. Inclusion in this directory is not an endorsement.