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NCT00064389 · ClinicalTrials.gov registry record · Phase 3

Long Term Safety Study of Levalbuterol and Racemic Albuterol in Subjects Twelve Years of Age and Older With Asthma

A Phase 3 study, sponsored by Sumitomo Pharma America.

Completed
Registry status
Phase 3
Development phase
746
Enrollment target

NCT00064389 is a Phase 3 study that has completed, run by Sumitomo Pharma America. The registered enrollment target is 746 participants.

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The verdict

NCT00064389, a Phase 3 study, has completed, sponsored by Sumitomo Pharma America.

COMPLETED
Registry status
Phase 3
Development phase
746 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the safety of levalbuterol as compared to racemic albuterol based on the frequencies of adverse events reporting during a 12-month period of chronic dosing of adolescent and adult subjects with asthma.

Interventions

  • DRUG levalbuterol tartrate HFA MDI
  • DRUG racemic albuterol

Trial Details

FieldValue
Enrollment Target 746 participants
Start Date 2003-01
Est. Completion 2005-07
Phase Phase 3

Sponsor

Sumitomo Pharma America

168 total trials

What the Registry Record Tells You About NCT00064389

The ClinicalTrials.gov registry entry for NCT00064389 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 746 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sumitomo Pharma America, which has 168 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which levalbuterol tartrate HFA MDI is the first listed.

NCT00064389 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00064389 about?

NCT00064389 is a clinical study titled "Long Term Safety Study of Levalbuterol and Racemic Albuterol in Subjects Twelve Years of Age and Older With Asthma". The purpose of this study is to evaluate the safety of levalbuterol as compared to racemic albuterol based on the frequencies of adverse events reporting during a 12-month period of chronic dosing of adolescent and adult subjects with asthma.

What is the current status of trial NCT00064389?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 746 participants. The study started on 2003-01. Estimated completion is 2005-07.

What interventions are being tested in trial NCT00064389?

The interventions under investigation include: levalbuterol tartrate HFA MDI (DRUG), racemic albuterol (DRUG).

Who is sponsoring clinical trial NCT00064389?

This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.

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.