Trial · NCT00561574
A Long-Term Safety Study of Org 50081 (Esmirtazapine) in Elderly Outpatients With Chronic Primary Insomnia (176005/P05697/MK-8265-001)
NCT00561574, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2014-07-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Long-Term Safety Study of Org 50081 (Esmirtazapine) in Elderly Outpatients With Chronic Primary Insomnia (176005/P05697/MK-8265-001). Trials, record NCT00561574. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00561574
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Long-Term Safety Study of Org 50081 (Esmirtazapine) in Elderly Outpatients With Chronic Primary Insomnia (176005/P05697/MK-8265-001)
- NCT number
- NCT00561574
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 259 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Sleep Initiation and Maintenance Disorder; Elderly, Mental Disorder, Dyssomnias, Sleep Disorders, Sleep Disorder, Intrinsic
- Interventions
- Esmirtazapine
- First posted
- 2007-11-21
- Last updated
- 2021-01-27
- Other registries' IDs
- eudract:2007-003636-35
- Results first posted
- 2014-07-07
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Experience at Least One Adverse Event (AE) | Up to 53 weeks | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to the study drug. |
| Primary | Number of Participants Who Discontinue Study Drug Due to an AE | Up to 52 weeks | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to the study drug. |
| Primary | Change From Baseline in Alertness at Awakening | Baseline and Week 52 | Alertness at awakening was assessed by participants using a 0-100 mm visual analog scale (VAS) in response to Weekly Sleep Diary question 6 "How did you feel upon awakening over the past 7 days?". Scores could range from 0=Tired to 100=Alert. Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using an observed cases (OC) approach. |
| Primary | Change From Baseline in Feeling Full of Energy | Baseline and Week 52 | Feeling full of energy was assessed by participants using a 0-100 mm visual analog scale (VAS) in response to Weekly Sleep Diary question 7 "How full of energy have you felt over the past 7 days?". Scores could range from 0=Terribly tired to 100=Full of energy. Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using an OC approach. |
| Primary | Change From Baseline in Ability to Work/Function | Baseline and Week 52 | Ability to work/function was assessed by participants using a 0-100 mm visual analog scale (VAS) in response to Weekly Sleep Diary question 8 "How were you able to work or function over the past 7 days?". Scores could range from 0=Not at all to 100=Very well. Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using an OC approach. |
| Primary | Change From Baseline in Total Nap Time | Baseline and Week 52 | Total nap time was assessed by participants in response to Weekly Sleep Diary question 9a "How much time per day did you nap, on average?". Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using an OC approach. |
| Secondary | Change From Baseline in Total Sleep Time (TST) | Baseline and Week 52 | TST was defined as the time recorded by participants in response to Weekly Sleep Diary question 4 "During the past 7 nights, how much time did you actually spend sleeping, on average?". Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using a last observation carried forward (LOCF) approach. |
| Secondary | Change From Baseline in Wake Time After Sleep Onset (WASO) | Baseline and Week 52 | WASO was defined as the time recorded by participants in response to Weekly Sleep Diary question 4 "During the past 7 nights, how much time were you awake, on average, after falling asleep initially?" Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using a LOCF approach. |
| Secondary | Change From Baseline in Sleep Latency (SL) | Baseline and Week 52 | SL was defined as the time recorded by participants in response to Weekly Sleep Diary question 4 "During the past 7 nights, how long did it take you to fall asleep, on average?" Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using a LOCF approach. |
| Secondary | Change From Baseline in Number of Awakenings (NAW) | Baseline and Week 52 | NAW was defined as the time recorded by participants in response to Weekly Sleep Diary question 2a "During the past 7 nights, how many times did you wake up, on average?" Baseline was defined as the Day 1 assessment of Days -7 to 1 before any study drug was taken. Change from Baseline was calculated using a LOCF approach. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Experience at Least One Adverse Event (AE) | Up to 53 weeks | The All-Subjects-Treated (AST) population consisted of all participants who received at least one dose of study drug. | Participants | NUMBER |
| PRIMARY | Number of Participants Who Discontinue Study Drug Due to an AE | Up to 52 weeks | The AST population consisted of all participants who received at least one dose of study drug. | Participants | NUMBER |
| PRIMARY | Change From Baseline in Alertness at Awakening | Baseline and Week 52 | The AST population consisted of all participants who received at least one dose of study drug. | Score on a Scale | MEAN |
| PRIMARY | Change From Baseline in Feeling Full of Energy | Baseline and Week 52 | The AST population consisted of all participants who received at least one dose of study drug. | Score on a Scale | MEAN |
| PRIMARY | Change From Baseline in Ability to Work/Function | Baseline and Week 52 | The AST population consisted of all participants who received at least one dose of study drug. | Score on a Scale | MEAN |
| PRIMARY | Change From Baseline in Total Nap Time | Baseline and Week 52 | The AST population consisted of all participants who received at least one dose of study drug. | Minutes | MEAN |
| SECONDARY | Change From Baseline in Total Sleep Time (TST) | Baseline and Week 52 | The Intent-To-Treat (ITT) population consisted of all participants who received at least one dose of study drug and had at least one postbaseline TST assessment. | Minutes | MEAN |
| SECONDARY | Change From Baseline in Wake Time After Sleep Onset (WASO) | Baseline and Week 52 | The ITT population consisted of all participants who received at least one dose of study drug and had at least one postbaseline WASO assessment. | Minutes | MEAN |
| SECONDARY | Change From Baseline in Sleep Latency (SL) | Baseline and Week 52 | The ITT population consisted of all participants who received at least one dose of study drug and had at least one postbaseline SL assessment. | Minutes | MEAN |
| SECONDARY | Change From Baseline in Number of Awakenings (NAW) | Baseline and Week 52 | The ITT population consisted of all participants who received at least one dose of study drug and had at least one postbaseline NAW assessment. | Number of Awakenings | MEAN |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Experience at Least One Adverse Event (AE) | Esmirtazapine 1.5 mg | 115 | Participants | ||
| Number of Participants Who Experience at Least One Adverse Event (AE) | Esmirtazapine 3.0 mg | 116 | Participants | ||
| Number of Participants Who Discontinue Study Drug Due to an AE | Esmirtazapine 1.5 mg | 21 | Participants | ||
| Number of Participants Who Discontinue Study Drug Due to an AE | Esmirtazapine 3.0 mg | 24 | Participants | ||
| Change From Baseline in Alertness at Awakening | Esmirtazapine 1.5 mg | Baseline (BL) (n=121, 123) | 38.3 | Standard Deviation 17.2 | Score on a Scale |
| Change From Baseline in Alertness at Awakening | Esmirtazapine 3.0 mg | Baseline (BL) (n=121, 123) | 38.3 | Standard Deviation 18.3 | Score on a Scale |
| Change From Baseline in Alertness at Awakening | Esmirtazapine 1.5 mg | Change from BL at Week 52 (n=61, 53) | 25.6 | Standard Deviation 29.1 | Score on a Scale |
| Change From Baseline in Alertness at Awakening | Esmirtazapine 3.0 mg | Change from BL at Week 52 (n=61, 53) | 21.7 | Standard Deviation 25.1 | Score on a Scale |
| Change From Baseline in Feeling Full of Energy | Esmirtazapine 1.5 mg | BL (n=121, 123) | 42.6 | Standard Deviation 16.8 | Score on a Scale |
| Change From Baseline in Feeling Full of Energy | Esmirtazapine 3.0 mg | BL (n=121, 123) | 43.3 | Standard Deviation 18.2 | Score on a Scale |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Esmirtazapine 1.5 mg | 128 | |
| Overall Study | STARTED | Esmirtazapine 3.0 mg | 131 | |
| Overall Study | COMPLETED | Esmirtazapine 1.5 mg | 80 | |
| Overall Study | COMPLETED | Esmirtazapine 3.0 mg | 73 | |
| Overall Study | NOT COMPLETED | Esmirtazapine 1.5 mg | 48 | |
| Overall Study | NOT COMPLETED | Esmirtazapine 3.0 mg | 58 |
Source ClinicalTrials.gov
Adverse events66
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Esmirtazapine 1.5 mg | 7 | 128 | 7 |
| other | Diarrhoea | Gastrointestinal disorders | Esmirtazapine 3.0 mg | 9 | 131 | 9 |
| other | Dry mouth | Gastrointestinal disorders | Esmirtazapine 1.5 mg | 10 | 128 | 13 |
| other | Dry mouth | Gastrointestinal disorders | Esmirtazapine 3.0 mg | 14 | 131 | 15 |
| other | Fatigue | General disorders | Esmirtazapine 1.5 mg | 17 | 128 | 18 |
| other | Fatigue | General disorders | Esmirtazapine 3.0 mg | 15 | 131 | 18 |
| other | Nasopharyngitis | Infections and infestations | Esmirtazapine 1.5 mg | 21 | 128 | 26 |
| other | Nasopharyngitis | Infections and infestations | Esmirtazapine 3.0 mg | 17 | 131 | 21 |
| other | Urinary tract infection | Infections and infestations | Esmirtazapine 1.5 mg | 2 | 128 | 3 |
| other | Urinary tract infection | Infections and infestations | Esmirtazapine 3.0 mg | 10 | 131 | 10 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Esmirtazapine 1.5 mg | ||
| Total, all-cause mortality | Esmirtazapine 3.0 mg | ||
| Total, other adverse events | Esmirtazapine 1.5 mg | 83 | 128 |
| Total, other adverse events | Esmirtazapine 3.0 mg | 102 | 131 |
| Total, serious adverse events | Esmirtazapine 1.5 mg | 9 | 128 |
| Total, serious adverse events | Esmirtazapine 3.0 mg | 6 | 131 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Esmirtazapine 1.5 mg vs Esmirtazapine 3.0 mg: Number of Participants Who Discontinue Study Drug Due to an AE | Trial comparisons |
| Esmirtazapine 1.5 mg vs Esmirtazapine 3.0 mg: Number of Participants Who Experience at Least One Adverse Event (AE) | Trial comparisons |
| Esmirtazapine 1.5 mg vs Esmirtazapine 3.0 mg: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00561574
GET https://conductscience.org/api/trials/v1/NCT00561574/results?page=2