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NCT00790400 · ClinicalTrials.gov registry record · Phase 3
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 Phase 3 study of Lymphangioleiomyomatosis (LAM) and Tuberous Sclerosis Complex (TSC), sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 118
- Enrollment target
- 20
- Study locations
NCT00790400: Completed Phase 3 study of Lymphangioleiomyomatosis (LAM) and Tuberous Sclerosis Complex (TSC), sponsored by Novartis Pharmaceuticals.
NCT00790400 is a Phase 3 study of Lymphangioleiomyomatosis (LAM) and Tuberous Sclerosis Complex (TSC) that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 118 participants, above the 12-participant average among 3 other Lymphangioleiomyomatosis (LAM) trials with a reported enrollment target (883% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00790400, a Phase 3 study of Lymphangioleiomyomatosis (LAM) and Tuberous Sclerosis Complex (TSC), has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 118 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the safety and efficacy of RAD001 in treating patients with Angiomyolipoma associated with Tuberous Sclerosis Complex or Sporadic Lymphangioleiomyomatosis.
Primary Outcome
Angiomyolipoma response defined as the combination of the following criteria: reduction in angiomyolipoma volume of ≥ 50% relative to baseline, where angiomyolipoma volume was sum of volumes of all target lesions identified at baseline, and with a confirmatory scan performed approximately 12 weeks later (no sooner than 8 weeks later); no new angiomyolipoma lesions ≥ 1.0 cm in longest diameter were identified; there were no kidney increases in volume \> 20% from nadir. The patient did not have an
Conditions Studied
Interventions
- DRUG Everolimus (RAD001)
- DRUG Everolimus Placebo
Study Locations (20)
Other
- Novartis Investigative Site - Berlin
- Novartis Investigative Site - München
- Novartis Investigative Site - Roma
- Novartis Investigative Site - Warsaw
- Novartis Investigative Site - Warsaw
- Novartis Investigative Site - Moscow
Alabama
- University of Alabama at Birmingham - Birmingham
Arizona
- Barrow Tuberous Sclerosis Center - Phoenix
Massachusetts
- Massachusetts General Hospital Massachussetts General Hospita - Boston
Minnesota
- Minnesota Epilepsy Group - Saint Paul
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Tennessee
- LeBonheur Childrens Medical Group SC-2 - Memphis
Ontario
- Novartis Investigative Site - Torono
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2009-04 |
| Est. Completion | 2015-11 |
| Phase | Phase 3 |
What the finished NCT00790400 record still lists
NCT00790400 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, above the 12-participant average among 3 other Lymphangioleiomyomatosis (LAM) trials with a reported enrollment target (883% higher).
The record links to 2 conditions, with Lymphangioleiomyomatosis (LAM) appearing as the primary indexed condition, and to 2 interventions - of which Everolimus (RAD001) is the first listed.
NCT00790400 names 20 study sites across 15 states, led by Other, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT00790400 about?
NCT00790400 is a clinical study titled "Efficacy and Safety of RAD001 in Patients Aged 18 and Over With Angiomyolipoma Associated With Either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)". This study will evaluate the safety and efficacy of RAD001 in treating patients with Angiomyolipoma associated with Tuberous Sclerosis Complex or Sporadic Lymphangioleiomyomatosis.
What is the current status of trial NCT00790400?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 118 participants. The study started on 2009-04. Estimated completion is 2015-11.
What conditions does trial NCT00790400 study?
This clinical trial studies the following conditions: Lymphangioleiomyomatosis (LAM), Tuberous Sclerosis Complex (TSC).
What interventions are being tested in trial NCT00790400?
The interventions under investigation include: Everolimus (RAD001) (DRUG), Everolimus Placebo (DRUG).
Who is sponsoring clinical trial NCT00790400?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00790400 being conducted?
This trial has 20 study locations across Alabama, Arizona, Massachusetts, Minnesota, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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