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NCT01854658 · ClinicalTrials.gov registry record · Phase 3
Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD (PINNACLE 2)
A Phase 3 study, sponsored by Pearl Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,615
- Enrollment target
NCT01854658 is a Phase 3 study that has completed, run by Pearl Therapeutics. The registered enrollment target is 1,615 participants.
The verdict
NCT01854658, a Phase 3 study, has completed, sponsored by Pearl Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,615 participants
- Enrollment target
Study Summary
This is a multicenter, randomized, double-blind, parallel group, chronic-dosing (24 weeks), placebo-controlled study to assess the efficacy and safety of Glycopyrrolate (GP and Formoterol Fumarate (FF) combination metered-dose inhaler (MDI) (GFF; PT003), GP MDI (PT001), and FF MDI (PT005) compared with Placebo MDI in subjects with moderate to very severe COPD.
Interventions
- DRUG Placebo
- DRUG GFF MDI (PT003)
- DRUG FF MDI (PT005)
- DRUG GP MDI (PT001)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,615 participants |
| Start Date | 2013-07 |
| Est. Completion | 2015-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01854658
The ClinicalTrials.gov registry entry for NCT01854658 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,615 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pearl Therapeutics, which has 31 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01854658 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01854658 about?
NCT01854658 is a clinical study titled "Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD (PINNACLE 2)". This is a multicenter, randomized, double-blind, parallel group, chronic-dosing (24 weeks), placebo-controlled study to assess the efficacy and safety of Glycopyrrolate (GP and Formoterol Fumarate (FF) combination metered-dose inhaler (MDI) (GFF; PT003), GP MDI (PT001), and FF MDI (PT005) compared w...
What is the current status of trial NCT01854658?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,615 participants. The study started on 2013-07. Estimated completion is 2015-03.
What interventions are being tested in trial NCT01854658?
The interventions under investigation include: Placebo (DRUG), GFF MDI (PT003) (DRUG), FF MDI (PT005) (DRUG), GP MDI (PT001) (DRUG).
Who is sponsoring clinical trial NCT01854658?
This trial is sponsored by Pearl Therapeutics, which has 31 total clinical trials registered on ClinicalTrials.gov.
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