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NCT01574703 · ClinicalTrials.gov registry record · Phase 4

Study To Evaluate Cardiac Assessments Following Different Treatments Of Smoking Cessation Medications In Subjects With And Without Psychiatric Disorders.

A Phase 4 study, sponsored by Pfizer.

Completed
Registry status
Phase 4
Development phase
4,595
Enrollment target

NCT01574703: Completed Phase 4 study, sponsored by Pfizer.

NCT01574703 is a Phase 4 study that has completed, run by Pfizer. The registered enrollment target is 4,595 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (787% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01574703, a Phase 4 study, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 4
Development phase
4,595 participants
Enrollment target

Study Summary

Non-treatment extension to study A3051123, aimed at collecting data on cardiovascular safety for all participants in the A3051123 trial for an additional 28 weeks, allowing for a total of 52 weeks of cardiovascular safety data collection.

Primary Outcome

This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug). The measure type mentioned in the outcome data table is Hazard Ratio relative to Placebo.

Interventions

  • DRUG placebo
  • DRUG Nicotine Replacement Therapy Patch
  • DRUG bupropion hydrochloride
  • DRUG varenicline tartrate

Trial Details

FieldValue
Enrollment Target 4,595 participants
Start Date 2012-05
Est. Completion 2015-07
Phase Phase 4
Pfizer

1,845 total trials

What the finished NCT01574703 record still lists

NCT01574703 is an interventional study that assigns participants to a tested intervention. Its 4,595 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 (787% higher).

The record links to 0 conditions, and to 4 interventions - of which placebo is the first listed.

NCT01574703 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01574703 about?

NCT01574703 is a clinical study titled "Study To Evaluate Cardiac Assessments Following Different Treatments Of Smoking Cessation Medications In Subjects With And Without Psychiatric Disorders.". Non-treatment extension to study A3051123, aimed at collecting data on cardiovascular safety for all participants in the A3051123 trial for an additional 28 weeks, allowing for a total of 52 weeks of cardiovascular safety data collection.

What is the current status of trial NCT01574703?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 4,595 participants. The study started on 2012-05. Estimated completion is 2015-07.

What interventions are being tested in trial NCT01574703?

The interventions under investigation include: placebo (DRUG), Nicotine Replacement Therapy Patch (DRUG), bupropion hydrochloride (DRUG), varenicline tartrate (DRUG).

Who is sponsoring clinical trial NCT01574703?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01574703's enrollment target sits among peer trials

4,595 18th of 2000 higher than 1,983 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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Source: ClinicalTrials.gov NCT01574703, the US trial registry maintained by the National Library of Medicine. NCT01574703 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.