CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 330 enrolled
Drug / intervention
Vareniclinedrug
Likely dose
Varenicline 0.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00794365
NCT00794365N/ACompleted

Post-Marketing Surveillance Study To Observe The Safety And Effectiveness Of Varenicline (Champix) Tablets In Smoking Cessation Among Filipino Subjects

Pfizer·observational·Posted Nov 20, 2008·Updated Dec 20, 2010

In Brief

An observational study evaluating Varenicline for Smoking Cessation. Completed, enrolled 330 participants.

Detailed Summary

The primary objective of this Post-Marketing Study is to monitor the safety of a novel smoking cessation drug Varenicline (Champix™) 0.5 mg and 1 mg tablets as used in clinical practice for 12 weeks among Filipino smokers. The secondary objective is to further evaluate the effectiveness of Varenicline (Champix™) as an aid in smoking cessation based on the 7-day point prevalence of smoking cessation

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 20, 2008
Enrollment StartJul 1, 2008
Primary CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.6 years ago

Interventions

Vareniclinedrug

There are two packs available for Varenicline (Champix™). The titration pack is prescribed initially to subjects with the recommended 1-week titration phase schedule as follows: Days 1-3 0.5 mg once daily Days 4-7 0.5 mg twice daily Day 8 - End of treatment 1 mg twice daily Following the titration period, Varenicline (Champix™) dosing is increased to 1mg twice daily for the remainder of the treatment period. Patient should set the target quit date to coincide with the start of 1 mg twice daily dosing. It should be taken after eating and with a full glass of water.