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| ID | Type | Description | Link |
|---|---|---|---|
| 176004 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Esmirtazapine | Experimental | One tablet of Esmirtazapine, 4.5 mg orally, daily for up to 52 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Org 50081 | Drug | One tablet daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Total Sleep Time at Week 52 | Total Sleep Time (TST) is a subjective time recorded by the participant in an electronic sleep diary in response to the question "How much time did you actually spend sleeping?". Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the last observation carried forward (LOCF) method, where the last available assessments prior to the scheduled observation were averaged. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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Participants who completed base studies P05706 (NCT00482612) and P05707 (NCT00506389) were eligible to enroll in follow-up study P05708
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| ID | Title | Description |
|---|---|---|
| FG000 | Esmirtazapine | One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants treated with Esmirtazapine in Follow up trial P05708
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| ID | Title | Description |
|---|---|---|
| BG000 | Esmirtazapine | One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All subjects treated (AST) population consisting of all enrolled participants who received at least one dose of trial medication | Posted | Number | Participants | Up to 57 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Esmirtazapine | One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Biliary colic | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000078785 | Mirtazapine |
| ID | Term |
|---|---|
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Baseline and Week 52 |
| Change From Baseline in Sleep Latency at Week 52 | Sleep Latency (SL) is the time from when the participant went to bed up to the the time the participant actually fell asleep, recorded by the participant in an electronic sleep diary. Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the LOCF method, where the last available assessments prior to the scheduled observation were averaged. | Baseline and Week 52 |
| Change From Baseline in Wake Time After Sleep Onset at Week 52 | Wake time after sleep onset (WASO) is, if the planned waking time is on or after the time of final awakening, as follows: total time from falling asleep to the time of planned wake up minus the total sleep time. If the planned waking time is before the time of final awakening then WASO is as follows: total time from falling asleep to the time of actual final awakening minus the total sleep time. All times were recorded by the participant in an electronic sleep diary. Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the LOCF method, where the last available assessments prior to the scheduled observation were averaged. | Baseline and Week 52 |
| Change From Baseline in Number of Awakenings at Week 52 | Number of awakenings is a subjective number recorded by the participant in an electronic sleep diary. Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the LOCF method, where the last available assessments prior to the scheduled observation were averaged. | Baseline and Week 52 |
| Change From Baseline in Quality of Sleep Scale at Week 52 | Quality of Sleep is a subjective number on a Visual Analog Scale recorded by the participant in an electronic sleep diary. The scale ranges from 0 to 100, where very poor is rated at 0, up to excellent, rated at 100. Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the LOCF method, where the last available assessments prior to the scheduled observation were averaged. | Baseline and Week 52 |
| Change From Baseline in Satisfaction With Sleep Duration Scale at Week 52 | Satisfaction with Sleep Duration is a subjective number on a Visual Analog Scale recorded by the participant in an electronic sleep diary. The scale ranges from 0 to 100, where very unsatisfied is rated at 0, up to fully satisfied, rated at 100. Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the LOCF method, where the last available assessments prior to the scheduled observation were averaged. | Baseline and Week 52 |
| Withdrawal by Subject |
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| Reasons unrelated to trial |
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| Lack of Compliance |
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| Lost to Follow-up |
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| Other reason (not specified) |
|
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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. | AST population consisting of all enrolled participants who received at least one dose of trial medication | Posted | Number | Participants | Up to 52 weeks |
|
|
|
| Secondary | Change From Baseline in Total Sleep Time at Week 52 | Total Sleep Time (TST) is a subjective time recorded by the participant in an electronic sleep diary in response to the question "How much time did you actually spend sleeping?". Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the last observation carried forward (LOCF) method, where the last available assessments prior to the scheduled observation were averaged. | AST participants who received at least one dose of trial medication and provided adequate data entries in their electronic sleep diary | Posted | Mean | Standard Deviation | Minutes | Baseline and Week 52 |
|
|
|
| Secondary | Change From Baseline in Sleep Latency at Week 52 | Sleep Latency (SL) is the time from when the participant went to bed up to the the time the participant actually fell asleep, recorded by the participant in an electronic sleep diary. Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the LOCF method, where the last available assessments prior to the scheduled observation were averaged. | AST participants who received at least one dose of trial medication and provided adequate data entries in their electronic sleep diary | Posted | Mean | Standard Deviation | Minutes | Baseline and Week 52 |
|
|
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| Secondary | Change From Baseline in Wake Time After Sleep Onset at Week 52 | Wake time after sleep onset (WASO) is, if the planned waking time is on or after the time of final awakening, as follows: total time from falling asleep to the time of planned wake up minus the total sleep time. If the planned waking time is before the time of final awakening then WASO is as follows: total time from falling asleep to the time of actual final awakening minus the total sleep time. All times were recorded by the participant in an electronic sleep diary. Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the LOCF method, where the last available assessments prior to the scheduled observation were averaged. | AST participants who received at least one dose of trial medication and provided adequate data entries in their electronic sleep diary | Posted | Mean | Standard Deviation | Minutes | Baseline and Week 52 |
|
|
|
| Secondary | Change From Baseline in Number of Awakenings at Week 52 | Number of awakenings is a subjective number recorded by the participant in an electronic sleep diary. Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the LOCF method, where the last available assessments prior to the scheduled observation were averaged. | AST participants who received at least one dose of trial medication and provided adequate data entries in their electronic sleep diary | Posted | Mean | Standard Deviation | Awakenings | Baseline and Week 52 |
|
|
|
| Secondary | Change From Baseline in Quality of Sleep Scale at Week 52 | Quality of Sleep is a subjective number on a Visual Analog Scale recorded by the participant in an electronic sleep diary. The scale ranges from 0 to 100, where very poor is rated at 0, up to excellent, rated at 100. Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the LOCF method, where the last available assessments prior to the scheduled observation were averaged. | AST participants who received at least one dose of trial medication and provided adequate data entries in their electronic sleep diary | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 52 |
|
|
|
| Secondary | Change From Baseline in Satisfaction With Sleep Duration Scale at Week 52 | Satisfaction with Sleep Duration is a subjective number on a Visual Analog Scale recorded by the participant in an electronic sleep diary. The scale ranges from 0 to 100, where very unsatisfied is rated at 0, up to fully satisfied, rated at 100. Baseline values were calculated by averaging baseline values from base trials P05706 and P05707. Data at baseline and at week 52 were collected every morning and evening for 7 consecutive days, and these data were then averaged. Missing values were imputed by the LOCF method, where the last available assessments prior to the scheduled observation were averaged. | AST participants who received at least one dose of trial medication and provided adequate data entries in their electronic sleep diary | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 52 |
|
|
|
| 8 |
| 342 |
| 118 |
| 342 |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
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| Skin laceration | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
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| Traumatic shock | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
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| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Victim of crime | Social circumstances | MedDRA 12.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Weight increased | Investigations | MedDRA 12.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| D001523 |
| Mental Disorders |