Conditions: Insomnia
Keywords: Fifty two weeks Open label extension
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 346
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: One tablet of Esmirtazapine, 4.5 mg orally, daily for up to 52 weeks

Interventions: intervention 1: Org 50081
Intervention descriptions: intervention 1: One tablet daily

Protocol document: