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A Study to Determine the Safety and Effectiveness of RAD001 (Everolimus) in Patients With Lymphangioleiomyomatosis

Lymphangioleiomyomatosis Clinical Trial

Official title:
An Exploratory, Open-label, Non-randomized, Within-patient Multiple Dose-escalation Safety, Tolerability, PK and Efficacy Trial of RAD001 (Everolimus) in Patients With Lymphangioleiomyomatosis

Clinical Trial Summary

This was an exploratory study to determine whether escalating doses of RAD001 (everolimus) were safe and effective in patients with Lymphangioleiomyomatosis

Clinical Trial Description

In addition to the data collected in this study, historical data from 43 patients treated with placebo from the multicenter trial of sirolimus in LAM (MILES) study (NCT00414648) were down weighted to an effective sample size of 18 for comparison of FEV1 and FVC endpoints. Reference to the publication of the MILES study has been provided under "Result Publication". ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01059318
Study type Interventional
Source Novartis
Contact
Status Completed
Phase Phase 2
Start date January 2010
Completion date June 2012
View Details
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