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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 1,714 participants |
| Start Date | 2017-01-13 |
| Est. Completion | 2018-05-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗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.
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