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NCT00572585 · ClinicalTrials.gov registry record · Phase 2

Efficacy, Safety and Tolerability of AEB071 in Patients With Active, Moderate to Severe Ulcerative Colitis

A Phase 2 study of Ulcerative Colitis, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
60
Enrollment target
20
Study locations

NCT00572585 is a Phase 2 study of Ulcerative Colitis that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 60 participants, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 7 states.

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The verdict

NCT00572585, a Phase 2 study of Ulcerative Colitis, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
60 participants
Enrollment target
20
Study locations

Study Summary

This study will evaluate the efficacy, safety and tolerability of AEB071 in the treatment of active, moderate to severe ulcerative colitis in patients who have failed conventional therapy using mesalamine or steroids

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG AEB071

Study Locations (20)

Other

  • Novartis Investigative Site - Aarhus
  • Novartis Investigative Site - Odense C
  • Novartis Investigative Site - Berlin
  • Novartis Investigative Site - Hamburg
  • Novartis Investigative Site - Hanover
  • Novartis Investigative Site - Kiel
  • Novartis Investigative Site - Leipzig
  • Novartis Investigative Site - Lüneburg
  • Novartis Investigative Site - Minden
  • Novartis Investigative Site - Regensburg
  • Novartis Investigative Site - Stuttgart
  • Novartis Investigative Site - Krakow
  • Novartis Investigative Site - Poznan

Michigan

  • Novartis Investigative Site - Chesterfield Twp
  • Novartis Investigative Site - Troy

Alabama

  • Novartis Investigative Site - Mobile

Arizona

  • Novartis Investigative Site - Mesa

Kansas

  • Novartis Investigative Site - Topeka

Louisiana

  • Novartis Investigative Site - Lafayette

Oklahoma

  • Novartis Investigative Site - Oklahoma City

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2010-04
Est. Completion 2012-04
Phase Phase 2

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT00572585

The ClinicalTrials.gov registry entry for NCT00572585 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,057-participant average among 122 other Ulcerative Colitis 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 Ulcerative Colitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT00572585 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Other, Michigan, Alabama.

Frequently Asked Questions

What is clinical trial NCT00572585 about?

NCT00572585 is a clinical study titled "Efficacy, Safety and Tolerability of AEB071 in Patients With Active, Moderate to Severe Ulcerative Colitis". This study will evaluate the efficacy, safety and tolerability of AEB071 in the treatment of active, moderate to severe ulcerative colitis in patients who have failed conventional therapy using mesalamine or steroids

What is the current status of trial NCT00572585?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2010-04. Estimated completion is 2012-04.

What conditions does trial NCT00572585 study?

This clinical trial studies the following conditions: Ulcerative Colitis.

What interventions are being tested in trial NCT00572585?

The interventions under investigation include: Placebo (DRUG), AEB071 (DRUG).

Who is sponsoring clinical trial NCT00572585?

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

Where is trial NCT00572585 being conducted?

This trial has 20 study locations across Alabama, Arizona, Kansas, Louisiana, Michigan. 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

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.