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Twenty-six Week Extension Trial of Org 50081 (Esmirtazapine) in Outpatients With Chronic Primary Insomnia (176003/P05721/MK-8265-007)

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ClinicalTrials.gov Identifier: NCT00750919
Recruitment Status : Terminated (This trial was stopped prematurely due to the Sponsor's decision not to continue the development of esmertazapine for this indication.)
First Posted : September 11, 2008
Results First Posted : June 24, 2014
Last Update Posted : July 24, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Sleep Initiation and Maintenance Disorders
Mental Disorders
Dyssomnias
Sleep Disorders
Sleep Disorders, Intrinsic
Intervention: Drug: esmirtazapine

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants who completed P05701 (Base study NCT00631657) were eligible to enroll on P05721 (Extension study).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Esmirtazapine Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months

Participant Flow:   Overall Study
    Esmirtazapine
STARTED   184 
COMPLETED   126 
NOT COMPLETED   58 
Adverse Event                9 
Withdrawal by Subject                1 
Lack of Efficacy                8 
Could not cooperate, unrelated to trial                4 
Other                36 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Esmirtazapine Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months

Baseline Measures
   Esmirtazapine 
Overall Participants Analyzed 
[Units: Participants]
 184 
Age 
[Units: Years]
Mean (Standard Deviation)
 47.8  (11.5) 
Gender 
[Units: Participants]
 
Female   111 
Male   73 


  Outcome Measures

1.  Primary:   Change From Baseline in Total Sleep Time (TST)   [ Time Frame: Baseline and Week 26 ]

2.  Primary:   Number of Participants Experiencing Adverse Events (AEs)   [ Time Frame: Up to 30 weeks ]

3.  Primary:   Number of Participants Discontinuing Due to AEs   [ Time Frame: Up to 26 weeks ]

4.  Secondary:   Change From Baseline in Sleep Latency (SL)   [ Time Frame: Baseline and Week 26 ]

5.  Secondary:   Change From Baseline in Wake Time After Sleep Onset (WASO)   [ Time Frame: Baseline and Week 26 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This study was terminated due to the Sponsor's decision not to continue development of esmertazapine for this indication.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00750919     History of Changes
Other Study ID Numbers: P05721
176003 ( Other Identifier: Organon Protocol Number )
2007-005237-10 ( EudraCT Number )
First Submitted: September 10, 2008
First Posted: September 11, 2008
Results First Submitted: May 22, 2014
Results First Posted: June 24, 2014
Last Update Posted: July 24, 2015