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

NCT01574703 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 4595

Last updated 2016-12-29

Study results available
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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.

Conditions

  • Smoking Cessation

Interventions

DRUG

placebo

All dosing to have taken place per study A3051123

DRUG

varenicline tartrate

All dosing to have taken place per study A3051123

DRUG

bupropion hydrochloride

All dosing to have taken place per study A3051123

DRUG

Nicotine Replacement Therapy Patch

All dosing to have taken place per study A3051123

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • Denmark
  • Finland
  • Germany
  • Mexico
  • New Zealand
  • Russia
  • Slovakia
  • South Africa
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01574703 on ClinicalTrials.gov