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NCT00925301 · ClinicalTrials.gov registry record · Phase 3

Study of the Effects of Oral AT1001 (Migalastat Hydrochloride) in Patients With Fabry Disease

A Phase 3 study of Fabry Disease, sponsored by Amicus Therapeutics.

Completed
Registry status
Phase 3
Development phase
67
Enrollment target
20
Study locations

NCT00925301 is a Phase 3 study of Fabry Disease that has completed, run by Amicus Therapeutics. The registered enrollment target is 67 participants, below the 541-participant average among 32 other Fabry Disease trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 14 states.

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The verdict

NCT00925301, a Phase 3 study of Fabry Disease, has completed, sponsored by Amicus Therapeutics.

COMPLETED
Registry status
Phase 3
Development phase
67 participants
Enrollment target
20
Study locations

Study Summary

The primary objective of this study was to compare the effect of migalastat (123 milligrams \[mg\] of migalastat \[equivalent to 150 mg of migalastat hydrochloride\]) (migalastat) versus placebo on kidney globotriaosylceramide (GL-3).

Conditions Studied

Fabry Disease

Interventions

  • DRUG Placebo
  • DRUG migalastat hydrochloride

Study Locations (20)

Other

  • - Buenos Aires
  • - Adelaide
  • - Parkville
  • - Porto Alegre
  • - São Paulo
  • - Copenhagen

California

  • - Los Angeles
  • - San Francisco

Georgia

  • - Decatur

Illinois

  • - Chicago

Kansas

  • - Kansas City

Massachusetts

  • - Boston

Michigan

  • - Grand Rapids

New York

  • - New York

Trial Details

FieldValue
Enrollment Target 67 participants
Start Date 2009-10-23
Est. Completion 2014-01-29
Phase Phase 3

Sponsor

Amicus Therapeutics

34 total trials

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What the Registry Record Tells You About NCT00925301

The ClinicalTrials.gov registry entry for NCT00925301 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 67 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 541-participant average among 32 other Fabry Disease trials with a reported enrollment target (88% lower). The listed sponsor is Amicus Therapeutics, which has 34 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Fabry Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT00925301 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Other, California, Georgia.

Frequently Asked Questions

What is clinical trial NCT00925301 about?

NCT00925301 is a clinical study titled "Study of the Effects of Oral AT1001 (Migalastat Hydrochloride) in Patients With Fabry Disease". The primary objective of this study was to compare the effect of migalastat (123 milligrams \[mg\] of migalastat \[equivalent to 150 mg of migalastat hydrochloride\]) (migalastat) versus placebo on kidney globotriaosylceramide (GL-3).

What is the current status of trial NCT00925301?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 67 participants. The study started on 2009-10-23. Estimated completion is 2014-01-29.

What conditions does trial NCT00925301 study?

This clinical trial studies the following conditions: Fabry Disease.

What interventions are being tested in trial NCT00925301?

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

Who is sponsoring clinical trial NCT00925301?

This trial is sponsored by Amicus Therapeutics, which has 34 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00925301 being conducted?

This trial has 20 study locations across California, Georgia, Illinois, Kansas, Massachusetts. 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.