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NCT01078298 · ClinicalTrials.gov registry record · Phase 4
Safety And Efficacy Of 12 Weeks Of Varenicline For Smoking Cessation In Smokers With Depression
A Phase 4 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 4
- Development phase
- 525
- Enrollment target
NCT01078298 is a Phase 4 study that has completed, run by Pfizer. The registered enrollment target is 525 participants.
The verdict
NCT01078298, a Phase 4 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 525 participants
- Enrollment target
Study Summary
Patients with depression tend to have a higher prevalence of smoking as well as increased severity of nicotine dependence. Phase 2 and Phase 3 varenicline clinical trials that demonstrated its efficacy and tolerability have not included subjects with depression. This smoking cessation study focuses on the depressed population and will assess the efficacy and safety of varenicline.
Interventions
- DRUG placebo
- DRUG varenicline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 525 participants |
| Start Date | 2010-03 |
| Est. Completion | 2012-06 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01078298
The ClinicalTrials.gov registry entry for NCT01078298 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 525 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01078298 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01078298 about?
NCT01078298 is a clinical study titled "Safety And Efficacy Of 12 Weeks Of Varenicline For Smoking Cessation In Smokers With Depression". Patients with depression tend to have a higher prevalence of smoking as well as increased severity of nicotine dependence. Phase 2 and Phase 3 varenicline clinical trials that demonstrated its efficacy and tolerability have not included subjects with depression. This smoking cessation study focuses ...
What is the current status of trial NCT01078298?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 525 participants. The study started on 2010-03. Estimated completion is 2012-06.
What interventions are being tested in trial NCT01078298?
The interventions under investigation include: placebo (DRUG), varenicline (DRUG).
Who is sponsoring clinical trial NCT01078298?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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