A twenty-six weeks, open-label extension trial to evaluate safety and efficacy of Org 50081 in outpatients with chronic primary insomnia who completed clinical trial protocol 21106. - Aquamarine
- Conditions
- Primary insomniaMedDRA version: 9.1 Level: LLT Classification code 10036701 Term: Primary insomnia
- Registration Number
- EUCTR2007-005237-10-FR
- Lead Sponsor
- V Organon
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 211
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method