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COMPLETED Phase 3

A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline for the Maintenance of Smoking Cessation

NCT00143286 · View on ClinicalTrials.gov ↗

Study Summary

The primary purpose of this study is a comparison of abstinence maintenance in subjects randomized to double-blind varenicline or placebo from Weeks 13 -24 in subjects who responded to an intial 12-week open label course of varenicline, with post-treatment follow-up of smoking status to Week 52.

Conditions Studied

Interventions

  • DRUG varenicline (CP-526,555)

Study Locations (20)

Other

  • Pfizer Investigational Site — Prague
  • Pfizer Investigational Site — Aarhus C
  • Pfizer Investigational Site — Frederikssund
  • Pfizer Investigational Site — Bergen
  • Pfizer Investigational Site — Hønefoss
  • Pfizer Investigational Site — Oslo
  • Pfizer Investigational Site — Gothenburg

Ontario

  • Pfizer Investigational Site — Ottawa
  • Pfizer Investigational Site — Toronto

California

  • Pfizer Investigational Site — Santa Ana

Florida

  • Pfizer Investigational Site — West Palm Beach

Kentucky

  • Pfizer Investigational Site — Lexington

Ohio

  • Pfizer Investigational Site — Mogadore

Texas

  • Pfizer Investigational Site — Dallas

Washington

  • Pfizer Investigational Site — Seattle

Trial Details

FieldValue
Enrollment Target 2,000 participants
Start Date 2003-04
Est. Completion 2005-03
Phase Phase 3

Sponsor

Pfizer

769 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00143286

The ClinicalTrials.gov registry entry for NCT00143286 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 769 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Smoking Cessation appearing as the primary indexed condition, and to 1 intervention — of which varenicline (CP-526,555) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00143286 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Other, Ontario, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00143286 about?

NCT00143286 is a clinical study titled "A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline for the Maintenance of Smoking Cessation". The primary purpose of this study is a comparison of abstinence maintenance in subjects randomized to double-blind varenicline or placebo from Weeks 13 -24 in subjects who responded to an intial 12-week open label course of varenicline, with post-treatment follow-up of smoking status to Week 52.

What is the current status of trial NCT00143286?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,000 participants. The study started on 2003-04. Estimated completion is 2005-03.

What conditions does trial NCT00143286 study?

This clinical trial studies the following conditions: Smoking Cessation. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00143286?

The interventions under investigation include: varenicline (CP-526,555) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00143286?

This trial is sponsored by Pfizer, which has 769 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00143286 being conducted?

This trial has 20 study locations across California, Florida, Kentucky, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial