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NCT01370356 · ClinicalTrials.gov registry record · Phase 4
A Study To Evaluate The Efficacy And Safety Of Varenicline Compared To Placebo For Smoking Cessation Through Reduction
A Phase 4 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 4
- Development phase
- 1,510
- Enrollment target
NCT01370356: Completed Phase 4 study, sponsored by Pfizer.
NCT01370356 is a Phase 4 study that has completed, run by Pfizer. The registered enrollment target is 1,510 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (192% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01370356, a Phase 4 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1,510 participants
- Enrollment target
Study Summary
This study will determine whether varenicline is safe and helps people to quit smoking through reduction when they are not willing/able to make an abrupt quit attempt.
Primary Outcome
Percentage of participants who remained abstinent from Week 15 to Week 24, inclusive, reporting no smoking and no use of nicotine-containing products since the last study visit or contact on the Nicotine Use Inventory (NUI) and confirmed by expired CO \< 10 ppm at any time point (CO measurements conducted at the clinic visits) during Weeks 15 through 24, inclusive. Missing CO was imputed as negative (CO ≤ 10 ppm).
Interventions
- DRUG Placebo
- DRUG Varenicline Tartrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,510 participants |
| Start Date | 2011-07 |
| Est. Completion | 2013-07 |
| Phase | Phase 4 |
What the finished NCT01370356 record still lists
NCT01370356 is an interventional study that assigns participants to a tested intervention. Its 1,510 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (192% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01370356 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01370356 about?
NCT01370356 is a clinical study titled "A Study To Evaluate The Efficacy And Safety Of Varenicline Compared To Placebo For Smoking Cessation Through Reduction". This study will determine whether varenicline is safe and helps people to quit smoking through reduction when they are not willing/able to make an abrupt quit attempt.
What is the current status of trial NCT01370356?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,510 participants. The study started on 2011-07. Estimated completion is 2013-07.
What interventions are being tested in trial NCT01370356?
The interventions under investigation include: Placebo (DRUG), Varenicline Tartrate (DRUG).
Who is sponsoring clinical trial NCT01370356?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01370356's enrollment target sits among peer trials
1,510 50th of 2000 higher than 1,951 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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