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NCT00463918 · ClinicalTrials.gov registry record · Phase 1

A Phase I Study to Evaluate the Pharmacokinetics of Multiple Doses of Varenicline in Healthy Adolescent Smokers

A Phase 1 study of Smoking Cessation, sponsored by Pfizer.

Completed
Registry status
Phase 1
Development phase
73
Enrollment target
16
Study locations

NCT00463918 is a Phase 1 study of Smoking Cessation that has completed, run by Pfizer. The registered enrollment target is 73 participants, below the 474-participant average among 188 other Smoking Cessation trials with a reported enrollment target (85% lower). The trial reports 16 study locations across 11 states.

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The verdict

NCT00463918, a Phase 1 study of Smoking Cessation, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 1
Development phase
73 participants
Enrollment target
16
Study locations

Study Summary

This study will investigate the multiple dose pharmacokinetics, safety, and tolerability of two dose strengths of varenicline in adolescents aged 12 to 16 years who regularly smoke at least three cigarettes per day.

Conditions Studied

Smoking Cessation

Interventions

  • DRUG varenicline

Study Locations (16)

Alabama

  • Pfizer Investigational Site - Anniston
  • Pfizer Investigational Site - Anniston

California

  • Pfizer Investigational Site - Anaheim
  • Pfizer Investigational Site - Los Angeles

Florida

  • Pfizer Investigational Site - DeLand
  • Pfizer Investigational Site - Gainesville

Hawaii

  • Pfizer Investigational Site - Honolulu
  • Pfizer Investigational Site - Honolulu

Kentucky

  • Pfizer Investigational Site - Bardstown
  • Pfizer Investigational Site - Lexington

Arizona

  • Pfizer Investigational Site - Phoenix

Arkansas

  • Pfizer Investigational Site - Hot Springs

Connecticut

  • Pfizer Investigational Site - New Haven

Trial Details

FieldValue
Enrollment Target 73 participants
Start Date 2007-05
Est. Completion 2007-12
Phase Phase 1

Sponsor

Pfizer

1,845 total trials

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What the Registry Record Tells You About NCT00463918

The ClinicalTrials.gov registry entry for NCT00463918 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 73 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 474-participant average among 188 other Smoking Cessation trials with a reported enrollment target (85% lower). The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Smoking Cessation appearing as the primary indexed condition, and to 1 intervention - of which varenicline is the first listed.

NCT00463918 reports 16 study locations spanning 11 distinct geographic areas - top geographies include Alabama, California, Florida.

Frequently Asked Questions

What is clinical trial NCT00463918 about?

NCT00463918 is a clinical study titled "A Phase I Study to Evaluate the Pharmacokinetics of Multiple Doses of Varenicline in Healthy Adolescent Smokers". This study will investigate the multiple dose pharmacokinetics, safety, and tolerability of two dose strengths of varenicline in adolescents aged 12 to 16 years who regularly smoke at least three cigarettes per day.

What is the current status of trial NCT00463918?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 73 participants. The study started on 2007-05. Estimated completion is 2007-12.

What conditions does trial NCT00463918 study?

This clinical trial studies the following conditions: Smoking Cessation.

What interventions are being tested in trial NCT00463918?

The interventions under investigation include: varenicline (DRUG).

Who is sponsoring clinical trial NCT00463918?

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

Where is trial NCT00463918 being conducted?

This trial has 16 study locations across Alabama, Arizona, Arkansas, California, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.