Primary insomnia MedDRA version: 9.1 Level: LLT Classification code 10036701 Term: Primary insomnia
Conditions
Interventions
Product Name: Org 50081
Product Code: Org 50081
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: esmirtazapine
CAS Number: 6
Sponsors
NV Organon
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects are eligible to participate in the trial, if they: 1. sign written informed consent after the scope and nature of the investigation have been explained to them, before any trial-related evaluations; 2. completed trial 21106 i.e. completed 26 weeks of treatment and finished the 7-day discontinuation period Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Potential participants will be excluded if they have experienced any of the following during trial 21106: 3. any adverse event, medical condition or required concomitant medication deemed relevant for exclusion in trial 21106 as judged by the investigator; 4. were significantly non compliant with protocol criteria and procedures of trial 21106, as judged by the investigator; 5. pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To investigate safety and tolerability of long-term treatment with Org 50081 in adult patients with chronic primary insomnia.;Secondary Objective: • To collect exploratory efficacy data of long-term treatment with Org 50081 in adult patients with chronic primary insomnia.;Primary end point(s): Safety and tolerability of long-term treatment with Org 50081 | — |
Countries
France, Germany, Hungary, Netherlands, Sweden, United Kingdom
Outcome results
None listed