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NCT02495168 · ClinicalTrials.gov registry record · Phase 3

Randomized, Placebo-Controlled, Multidose, Study Comparing Generic Budesonide/Formoterol Fumarate Dihydrate to Symbicort® in Asthmatic Participants

A Phase 3 study, sponsored by Actavis.

Completed
Registry status
Phase 3
Development phase
1,714
Enrollment target

NCT02495168 is a Phase 3 study that has completed, run by Actavis. The registered enrollment target is 1,714 participants.

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The verdict

NCT02495168, a Phase 3 study, has completed, sponsored by Actavis.

COMPLETED
Registry status
Phase 3
Development phase
1,714 participants
Enrollment target

Study Summary

This study has a randomized multiple-dose, placebo-controlled, parallel group design consisting of a 2-week open placebo Run-in Period followed by a 6-week Treatment Period with placebo, test product (budesonide 80 microgram \[μg\]/formoterol fumarate dihydrate 4.5 μg), or reference product (Symbicort® inhalation aerosol).

Interventions

  • DRUG Placebo
  • DRUG Generic Budesonide/Formoterol Fumarate Dihydrate
  • DRUG Symbicort® (Budesonide/Formoterol Fumarate Dihydrate)

Trial Details

FieldValue
Enrollment Target 1,714 participants
Start Date 2017-01-13
Est. Completion 2018-05-31
Phase Phase 3

Sponsor

Actavis

79 total trials

What the Registry Record Tells You About NCT02495168

The ClinicalTrials.gov registry entry for NCT02495168 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,714 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Actavis, which has 79 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT02495168 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02495168 about?

NCT02495168 is a clinical study titled "Randomized, Placebo-Controlled, Multidose, Study Comparing Generic Budesonide/Formoterol Fumarate Dihydrate to Symbicort® in Asthmatic Participants". This study has a randomized multiple-dose, placebo-controlled, parallel group design consisting of a 2-week open placebo Run-in Period followed by a 6-week Treatment Period with placebo, test product (budesonide 80 microgram \[μg\]/formoterol fumarate dihydrate 4.5 μg), or reference product (Symbico...

What is the current status of trial NCT02495168?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,714 participants. The study started on 2017-01-13. Estimated completion is 2018-05-31.

What interventions are being tested in trial NCT02495168?

The interventions under investigation include: Placebo (DRUG), Generic Budesonide/Formoterol Fumarate Dihydrate (DRUG), Symbicort® (Budesonide/Formoterol Fumarate Dihydrate) (DRUG).

Who is sponsoring clinical trial NCT02495168?

This trial is sponsored by Actavis, which has 79 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.