Phase 3
Completed N=346
Fifty Two Week Extension Trial of Org 50081 (Esmirtazapine) in the Treatment of Insomnia (P05708)
Source: ClinicalTrials.gov NCT00610675 ↗Enrolled (actual)
346
Serious AEs
2.3%
Results posted
Jul 2014
Primary outcomePrimary: Number of Participants With an Adverse Event — 235 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With an Adverse Event |
235 | — |
| PRIMARY Number of Participants Who Discontinued Treatment Due to an Adverse Event |
67 | — |
| SECONDARY Change From Baseline in Total Sleep Time at Week 52 |
331.7; 73.0 | — |
| SECONDARY Change From Baseline in Sleep Latency at Week 52 |
70.9; -24.5 | — |
| SECONDARY Change From Baseline in Wake Time After Sleep Onset at Week 52 |
85.0; -34.8 | — |
| SECONDARY Change From Baseline in Number of Awakenings at Week 52 |
2.0; -0.7 | — |
| SECONDARY Change From Baseline in Quality of Sleep Scale at Week 52 |
43.9; 17.3 | — |
| SECONDARY Change From Baseline in Satisfaction With Sleep Duration Scale at Week 52 |
41.3; 19.2 | — |
Eligibility Criteria
Inclusion Criteria
- sign written informed consent after the scope and nature of the investigation have been explained to them, before any trial-related evaluations;
- completed Protocol P05706 or P05707;
- Have safety and efficacy assessments conducted per protocol P05706 or P05707.
Exclusion Criteria
- clinically relevant electrocardiogram (ECG) abnormalities as judged by the investigator;
- clinically relevant abnormal laboratory values as judged by the investigator;
- any adverse event deemed relevant for exclusion in Protocol P05708 as judged by the investigator or,
- were significantly non compliant with protocol criteria and procedures of Protocol P05706 or P05707, as judged by the investigator.
Data sourced from ClinicalTrials.gov (NCT00610675). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.