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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 : October 12, 2018
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
Enrollment 184
Recruitment Details Participants who completed P05701 (Base study NCT00631657) were eligible to enroll on P05721 (Extension study).
Pre-assignment Details  
Arm/Group Title Esmirtazapine
Hide Arm/Group Description Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months
Period Title: Overall Study
Started 184
Completed 126
Not Completed 58
Reason Not Completed
Adverse Event             9
Withdrawal by Subject             1
Lack of Efficacy             8
Could not cooperate, unrelated to trial             4
Other             36
Arm/Group Title Esmirtazapine
Hide Arm/Group Description Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months
Overall Number of Baseline Participants 184
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 184 participants
47.8  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 184 participants
Female
111
  60.3%
Male
73
  39.7%
1.Primary Outcome
Title Change From Baseline in Total Sleep Time (TST)
Hide Description TST was defined as the time recorded for sleep diary question 6 "how much time did you actually spend sleeping" as reported by the participants using a LogPad (hand-held electronic data capture device). Baseline was defined as the TST from the last week of the base study. Daily diary data were converted to weekly averages. For each treatment week the non-missing diary data of that week were taken into account; if a treatment week had three non-missing morning diaries or less, the data of the previous week were taken into account, weighing the data of both weeks, using the number of observed diaries as weights (weighted mean); if no diary data were available for a treatment week the data were considered as missing and were not imputed.
Time Frame Baseline and Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The All-Subjects-Treated (AST) population consisted of all participants who received at least one dose of esmertazapine in the extension study.
Arm/Group Title Esmirtazapine
Hide Arm/Group Description:
Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months
Overall Number of Participants Analyzed 184
Mean (Standard Deviation)
Unit of Measure: Minutes per night
Baseline measure (n=184) 368.1  (91.5)
Change from baseline at Week 26 (n=123) 9.7  (56.1)
2.Primary Outcome
Title Number of Participants Experiencing Adverse Events (AEs)
Hide Description An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
Time Frame Up to 30 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The AST population consisted of all participants who received at least one dose of esmertazapine in the extension study.
Arm/Group Title Esmirtazapine
Hide Arm/Group Description:
Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months
Overall Number of Participants Analyzed 184
Measure Type: Number
Unit of Measure: Participants
127
3.Primary Outcome
Title Number of Participants Discontinuing Due to AEs
Hide Description An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
Time Frame Up to 26 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The AST population consisted of all participants who received at least one dose of esmertazapine in the extension study.
Arm/Group Title Esmirtazapine
Hide Arm/Group Description:
Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months
Overall Number of Participants Analyzed 184
Measure Type: Number
Unit of Measure: Participants
9
4.Secondary Outcome
Title Change From Baseline in Sleep Latency (SL)
Hide Description SL was defined as the time recorded for sleep diary question 3 "how long did it take you to fall asleep’, " as reported by the participants using a LogPad (hand-held electronic data capture device). Baseline was defined as the SL from the last week of the base study. Daily diary data were converted to weekly averages. For each treatment week the non-missing diary data of that week were taken into account; if a treatment week had three non-missing morning diaries or less, the data of the previous week were taken into account, weighing the data of both weeks, using the number of observed diaries as weights (weighted mean); if no diary data were available for a treatment week the data were considered as missing and were not imputed.
Time Frame Baseline and Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The All-Subjects-Treated (AST) population consisted of all participants who received at least one dose of esmertazapine in the extension study.
Arm/Group Title Esmirtazapine
Hide Arm/Group Description:
Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months
Overall Number of Participants Analyzed 148
Mean (Standard Deviation)
Unit of Measure: Minutes per night
Baseline measure (n=184) 38.7  (32.0)
Change from baseline at Week 26 (n=123) -1.5  (39.1)
5.Secondary Outcome
Title Change From Baseline in Wake Time After Sleep Onset (WASO)
Hide Description WASO was defined as the time recorded for sleep diary question 5 "how much time were you awake, after falling asleep initially" as reported by the participants using a LogPad (hand-held electronic data capture device). Baseline was defined as the WASO from the last week of the base study. Daily diary data were converted to weekly averages. For each treatment week the non-missing diary data of that week were taken into account; if a treatment week had three non-missing morning diaries or less, the data of the previous week were taken into account, weighing the data of both weeks, using the number of observed diaries as weights (weighted mean); if no diary data were available for a treatment week the data were considered as missing and were not imputed.
Time Frame Baseline and Week 26
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The AST population consisted of all participants who received at least one dose of esmertazapine in the extension study.
Arm/Group Title Esmirtazapine
Hide Arm/Group Description:
Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months
Overall Number of Participants Analyzed 148
Mean (Standard Deviation)
Unit of Measure: Minutes per night
Baseline measure (n=184) 40.0  (43.5)
Change from baseline at Week 26 (n=123) -5.4  (32.3)
Time Frame Nonserious AEs were collected from first dispensing of study drug up to 7 days after last dose of study drug. Serious AEs were collected from first dispensing of study drug up to 30 days after last dose of study drug.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Esmirtazapine
Hide Arm/Group Description Participants receive esmirtazapine 4.5 mg tablet, orally, once daily (QD) for up to 6 months
All-Cause Mortality
Esmirtazapine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Esmirtazapine
Affected / at Risk (%) # Events
Total   3/184 (1.63%)    
Cardiac disorders   
Acute myocardial infarction  1  1/184 (0.54%)  1
Musculoskeletal and connective tissue disorders   
Intervertebral disc degeneration  1  1/184 (0.54%)  1
Surgical and medical procedures   
Strabismus correction  1  1/184 (0.54%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Esmirtazapine
Affected / at Risk (%) # Events
Total   59/184 (32.07%)    
Infections and infestations   
Nasopharyngitis  1  19/184 (10.33%)  20
Investigations   
Weight increased  1  11/184 (5.98%)  12
Nervous system disorders   
Headache  1  10/184 (5.43%)  13
Somnolence  1  10/184 (5.43%)  11
Psychiatric disorders   
Insomnia  1  23/184 (12.50%)  23
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
This study was terminated due to the Sponsor's decision not to continue development of esmertazapine for this indication.
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.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
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: October 12, 2018