drugset / Trial / NCT00610675

Fifty Two Week Extension Trial of Org 50081 (Esmirtazapine) in the Treatment of Insomnia (P05708)

NCT00610675

Phase 3 Completed 346 enrolled Merck Sharp & Dohme LLC
NaSingle-groupOpen-labelTreatment

Summary

This trial is a 52-week, open-label extension trial to investigate safety and to explore efficacy of Org 50081 (Esmirtazapine) in participants who completed Protocol 176001 (P05706) (NCT00482612) or 176002 (P05707) (NCT00506389). Participants who have completed Protocol P05706 or P05707, and are willing to continue treatment with Esmirtazapine, can participate in Protocol 176004 (P05708) after signing informed consent.

Timeline

Start
2006-12-07
Primary completion
2009-08-17
Completion
2009-08-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Esmirtazapine Small molecule 4.5 mg Oral

Indications