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NCT01059318 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Lymphangioleiomyomatosis, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
24
Enrollment target
4
Study locations

NCT01059318 is a Phase 2 study of Lymphangioleiomyomatosis that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 24 participants, below the 828-participant average among 10 other Lymphangioleiomyomatosis trials with a reported enrollment target (97% lower). The trial reports 4 study locations across 3 states.

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The verdict

NCT01059318, a Phase 2 study of Lymphangioleiomyomatosis, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
24 participants
Enrollment target
4
Study locations

Study Summary

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

Conditions Studied

Lymphangioleiomyomatosis

Interventions

  • DRUG Everolimus

Study Locations (4)

Other

  • Novartis Investigative Site - Lyon
  • Novartis Investigative Site - Milan

Massachusetts

  • Center for LAM Research and Clinical Care - Boston

Ohio

  • University of Cincinnati, Department of Internal Medicine, Pulmonary, Critical Care & Sleep Medicine, - Cincinnati

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2010-01
Est. Completion 2012-06
Phase Phase 2

Sponsor

Novartis Pharmaceuticals

1,375 total trials

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What the Registry Record Tells You About NCT01059318

The ClinicalTrials.gov registry entry for NCT01059318 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 828-participant average among 10 other Lymphangioleiomyomatosis trials with a reported enrollment target (97% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Lymphangioleiomyomatosis appearing as the primary indexed condition, and to 1 intervention - of which Everolimus is the first listed.

NCT01059318 reports 4 study locations spanning 3 distinct geographic areas - top geographies include Other, Massachusetts, Ohio.

Frequently Asked Questions

What is clinical trial NCT01059318 about?

NCT01059318 is a clinical study titled "A Study to Determine the Safety and Effectiveness of RAD001 (Everolimus) in Patients With Lymphangioleiomyomatosis". This was an exploratory study to determine whether escalating doses of RAD001 (everolimus) were safe and effective in patients with Lymphangioleiomyomatosis

What is the current status of trial NCT01059318?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2010-01. Estimated completion is 2012-06.

What conditions does trial NCT01059318 study?

This clinical trial studies the following conditions: Lymphangioleiomyomatosis.

What interventions are being tested in trial NCT01059318?

The interventions under investigation include: Everolimus (DRUG).

Who is sponsoring clinical trial NCT01059318?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01059318 being conducted?

This trial has 4 study locations across Massachusetts, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.