drugset / Trial / NCT00401726

Open-Label, Randomized Study Evaluating Treatment With Venlafaxine Extended-Release Plus Dialogues Time to Talk Program

NCT00401726 ↗

Phase 4 Completed 537 enrolled Wyeth is now a wholly owned subsidiary of Pfizer
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the effect of the Dialogues Time to Talk program in subjects treated with Venlafaxine Extended Release (ER). Dialogues Time to Talk Program is a patient management program, which aims to help patients achieve successful outcomes by reinforcing physician treatment efforts, providing feedback to treating physicians, and encouraging better physician-patient communications.

Timeline

Start
2006-06
Primary completion
—
Completion
2007-10

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Venlafaxine Extended Release (ER) vs Venlafaxine Extended Release (ER) Plus Dialogues; p = 0.218; Risk Difference (RD) 5.25; Chi-squared NCT00401726 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Venlafaxine Small molecule — —