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

NCT00610675 | Completed Phase 3 Results

• 2 other identifiers: P05708176004
• Study Type: interventional
• Target: 346
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Insomnia

Keywords

Fifty two weeks; Open label; extension

Outcome Measures

Primary Outcomes (2)

• Number of Participants With an Adverse Event

  An Adverse Event (AE) is any untoward occurrence in a participant who is administered any pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding) symptom, or disease temporarily associated with the use of an investigational medicinal product (IMP), whether or not it is related to the IMP.

  Up to 57 weeks

• Number of Participants Who Discontinued Treatment Due to an Adverse Event

  An Adverse Event (AE) is any untoward occurrence in a participant who is administered any pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding) symptom, or disease temporarily associated with the use of an IMP, whether or not it is related to the IMP.

  Up to 52 weeks

Secondary Outcomes (6)

• Change From Baseline in Total Sleep Time at Week 52

  Baseline and Week 52

• Change From Baseline in Sleep Latency at Week 52

  Baseline and Week 52

• Change From Baseline in Wake Time After Sleep Onset at Week 52

  Baseline and Week 52

• Change From Baseline in Number of Awakenings at Week 52

  Baseline and Week 52

• Change From Baseline in Quality of Sleep Scale at Week 52

  Baseline and Week 52

Study Arms (1)

Esmirtazapine

EXPERIMENTAL

One tablet of Esmirtazapine, 4.5 mg orally, daily for up to 52 weeks

Drug: Org 50081

Interventions

Org 50081 DRUG

One tablet daily

Esmirtazapine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• clinically relevant electrocardiogram (ECG) abnormalities as judged by the investigator;
• clinically relevant abnormal laboratory values as judged by the investigator;
• were significantly non compliant with protocol criteria and procedures of Protocol P05706 or P05707, as judged by the investigator.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Mirtazapine

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2008
• First Posted: February 8, 2008
• Study Start: December 7, 2006
• Primary Completion: August 17, 2009
• Study Completion: August 17, 2009
• Last Updated: October 3, 2018
• Results First Posted: July 30, 2014

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share