Trial Outcomes & Findings for Study of the Safety and Effectiveness of Esmirtazapine in Participants With Chronic Primary Insomnia (P05706) (NCT NCT00482612)
NCT ID: NCT00482612
Last Updated: 2018-10-03
Results Overview
TST was defined as the total amount of time (measured in minutes) that was actually spent sleeping the previous night as recorded daily in the participant's sleep diary. TST values over the 14-day active treatment period were averaged for each participant, and average TST was then reported by treatment arm. For participants with missing data, the average of the nights for which TST data were present was used in the analysis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
526 participants
Primary outcome timeframe
Day 1 to Day 15
Results posted on
2018-10-03
Participant Flow
Participant milestones
| Measure |
Esmirtazapine 1.5 mg
Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period. Participants were followed for safety during a Follow-up Period, in which no study medication was administered.
|
Esmirtazapine 3.0 mg
Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period. Participants were followed for safety during a Follow-up Period, in which no study medication was administered.
|
Esmirtazapine 4.5 mg
Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period. Participants were followed for safety during a Follow-up Period, in which no study medication was administered.
|
Placebo
Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period. Participants were followed for safety during a Follow-up Period, in which no study medication was administered.
|
|---|---|---|---|---|
|
In-treatment Period
STARTED
|
137
|
125
|
129
|
135
|
|
In-treatment Period
Treated
|
137
|
125
|
128
|
135
|
|
In-treatment Period
COMPLETED
|
137
|
125
|
128
|
135
|
|
In-treatment Period
NOT COMPLETED
|
0
|
0
|
1
|
0
|
|
Follow-up Period
STARTED
|
137
|
125
|
128
|
135
|
|
Follow-up Period
COMPLETED
|
123
|
107
|
106
|
127
|
|
Follow-up Period
NOT COMPLETED
|
14
|
18
|
22
|
8
|
Reasons for withdrawal
| Measure |
Esmirtazapine 1.5 mg
Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period. Participants were followed for safety during a Follow-up Period, in which no study medication was administered.
|
Esmirtazapine 3.0 mg
Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period. Participants were followed for safety during a Follow-up Period, in which no study medication was administered.
|
Esmirtazapine 4.5 mg
Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period. Participants were followed for safety during a Follow-up Period, in which no study medication was administered.
|
Placebo
Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period. Participants were followed for safety during a Follow-up Period, in which no study medication was administered.
|
|---|---|---|---|---|
|
In-treatment Period
No study medication administered
|
0
|
0
|
1
|
0
|
|
Follow-up Period
Other
|
4
|
2
|
1
|
2
|
|
Follow-up Period
Lack of compliance
|
0
|
0
|
1
|
0
|
|
Follow-up Period
Lost to Follow-up
|
0
|
4
|
2
|
1
|
|
Follow-up Period
Adverse Event
|
4
|
7
|
9
|
0
|
|
Follow-up Period
Lack of Efficacy
|
2
|
0
|
1
|
0
|
|
Follow-up Period
Withdrawal by Subject
|
3
|
5
|
7
|
2
|
|
Follow-up Period
Reasons not related to trial
|
1
|
0
|
1
|
3
|
Baseline Characteristics
Study of the Safety and Effectiveness of Esmirtazapine in Participants With Chronic Primary Insomnia (P05706)
Baseline characteristics by cohort
| Measure |
Esmirtazapine 1.5 mg
n=137 Participants
Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period. No study medication was administered during the Follow-up Period.
|
Esmirtazapine 3.0 mg
n=125 Participants
Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period. No study medication was administered during the Follow-up Period.
|
Esmirtazapine 4.5 mg
n=128 Participants
Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period. No study medication was administered during the Follow-up Period.
|
Placebo
n=135 Participants
Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period. No study medication was administered during the Follow-up Period.
|
Total
n=525 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
44.8 Years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
45.6 Years
STANDARD_DEVIATION 12.0 • n=7 Participants
|
44.5 Years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
46.2 Years
STANDARD_DEVIATION 11.3 • n=4 Participants
|
45.3 Years
STANDARD_DEVIATION 12.0 • n=21 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
339 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
186 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 15Population: The Intent-To-Treat Group consisted of all randomized participants who received at least one dose of double-blind trial medication, and had baseline and at least one post-baseline measurement for at least one efficacy assessment.
TST was defined as the total amount of time (measured in minutes) that was actually spent sleeping the previous night as recorded daily in the participant's sleep diary. TST values over the 14-day active treatment period were averaged for each participant, and average TST was then reported by treatment arm. For participants with missing data, the average of the nights for which TST data were present was used in the analysis.
Outcome measures
| Measure |
Esmirtazapine 1.5 mg
n=135 Participants
Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
|
Esmirtazapine 3.0 mg
n=121 Participants
Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period.
|
Esmirtazapine 4.5 mg
n=126 Participants
Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
|
Placebo
n=133 Participants
Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period.
|
|---|---|---|---|---|
|
Average Total Sleep Time (TST) as Recorded Daily in the Sleep Diary During the 14-day In-treatment Period
|
382.14 Minutes
Standard Deviation 68.155
|
382.77 Minutes
Standard Deviation 81.172
|
394.83 Minutes
Standard Deviation 85.575
|
351.40 Minutes
Standard Deviation 78.551
|
SECONDARY outcome
Timeframe: Day 1 to Day 15Population: The Intent-To-Treat Group consisted of all randomized participants who received at least one dose of double-blind trial medication and had baseline and at least one post-baseline measurement for at least one efficacy assessment.
SL was defined as the duration of time measured in minutes that it took a participant to fall asleep as recorded daily in the participant's sleep diary. SL values over the 14-day active treatment period were averaged for each participant, and average SL was then reported by treatment arm. For participants with missing data, the average of the nights for which TST data were present were used in the analysis.
Outcome measures
| Measure |
Esmirtazapine 1.5 mg
n=135 Participants
Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
|
Esmirtazapine 3.0 mg
n=121 Participants
Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period.
|
Esmirtazapine 4.5 mg
n=126 Participants
Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
|
Placebo
n=133 Participants
Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period.
|
|---|---|---|---|---|
|
Average Sleep Latency (SL) as Recorded Daily in the Sleep Diary During the 14-day In-treatment Period
|
48.93 Minutes
Standard Deviation 34.59
|
52.02 Minutes
Standard Deviation 38.95
|
50.80 Minutes
Standard Deviation 45.76
|
60.13 Minutes
Standard Deviation 42.98
|
SECONDARY outcome
Timeframe: Day 1 to Day 15Population: The All-Subjects-Treated Group consisted of all participants who received at least 1 dose of trial medication.
The total number of participants with an AE during the 14-day In-treatment Period was tallied for each treatment arm. An AE was defined as any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Outcome measures
| Measure |
Esmirtazapine 1.5 mg
n=137 Participants
Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
|
Esmirtazapine 3.0 mg
n=125 Participants
Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period.
|
Esmirtazapine 4.5 mg
n=128 Participants
Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
|
Placebo
n=135 Participants
Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period.
|
|---|---|---|---|---|
|
Number of Participants Experiencing an Adverse Event (AE) During the 14-day In-treatment Period
|
35 Number of participants
|
41 Number of participants
|
41 Number of participants
|
28 Number of participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 15Population: The All-Subjects-Treated Group consisted of all participants who received at least 1 dose of trial medication.
The total number of participants discontinuing from study treatment due to experiencing an AE was tallied for each treatment arm. An AE was defined as any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Outcome measures
| Measure |
Esmirtazapine 1.5 mg
n=137 Participants
Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
|
Esmirtazapine 3.0 mg
n=125 Participants
Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period.
|
Esmirtazapine 4.5 mg
n=128 Participants
Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
|
Placebo
n=135 Participants
Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period.
|
|---|---|---|---|---|
|
Number of Participants Who Discontinued From Study Treatment Due to an AE During the 14-day In-Treatment Period
|
4 Number of participants
|
7 Number of participants
|
9 Number of participants
|
0 Number of participants
|
Adverse Events
Esmirtazapine 1.5 mg In-treatment
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Esmirtazapine 3.0 mg In-Treatment
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Esmirtazapine 4.5 mg In-treatment
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo In-treatment
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Esmirtazapine 1.5 mg Follow-up
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Esmirtazapine 3.0 mg Folow-up
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Esmirtazapine 4.5 mg Follow-up
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Follow-up
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Esmirtazapine 1.5 mg In-treatment
n=137 participants at risk
Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
|
Esmirtazapine 3.0 mg In-Treatment
n=125 participants at risk
Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period.
|
Esmirtazapine 4.5 mg In-treatment
n=128 participants at risk
Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
|
Placebo In-treatment
n=135 participants at risk
Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period.
|
Esmirtazapine 1.5 mg Follow-up
n=137 participants at risk
After receiving 1.5 mg esmirtazipine in the In-Treatment Period, participants were followed for safety during a Follow-up Period in which no study medication was administered.
|
Esmirtazapine 3.0 mg Folow-up
n=125 participants at risk
After receiving 3.0 mg esmirtazipine in the In-Treatment Period, participants were followed for safety during a Follow-up Period in which no study medication was administered.
|
Esmirtazapine 4.5 mg Follow-up
n=128 participants at risk
After receiving 4.5 mg esmirtazipine in the In-Treatment Period, participants were followed for safety during a Follow-up Period in which no study medication was administered.
|
Placebo Follow-up
n=135 participants at risk
After receiving placebo in the In-Treatment Period, participants were followed for safety during a Follow-up Period in which no study medication was administered.
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/137 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
0.00%
0/125 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
0.78%
1/128 • Number of events 1 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
0.00%
0/135 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
0.00%
0/137 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
0.00%
0/125 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
0.00%
0/128 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
0.00%
0/135 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
|
Infections and infestations
Bronchitis
|
0.73%
1/137 • Number of events 1 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
0.00%
0/125 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
0.00%
0/128 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
0.00%
0/135 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
0.00%
0/137 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
0.00%
0/125 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
0.00%
0/128 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
0.00%
0/135 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
|
Infections and infestations
Staphylococcal infection
|
0.73%
1/137 • Number of events 1 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
0.00%
0/125 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
0.00%
0/128 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
0.00%
0/135 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
0.00%
0/137 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
0.00%
0/125 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
0.00%
0/128 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
0.00%
0/135 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.73%
1/137 • Number of events 1 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
0.00%
0/125 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
0.00%
0/128 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
0.00%
0/135 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
0.00%
0/137 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
0.00%
0/125 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
0.00%
0/128 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
0.00%
0/135 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.73%
1/137 • Number of events 1 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
0.00%
0/125 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
0.00%
0/128 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
0.00%
0/135 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
0.00%
0/137 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
0.00%
0/125 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
0.00%
0/128 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
0.00%
0/135 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
|
Surgical and medical procedures
Abdominoplasty
|
0.00%
0/137 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
0.80%
1/125 • Number of events 1 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
0.00%
0/128 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
0.00%
0/135 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
0.00%
0/137 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
0.00%
0/125 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
0.00%
0/128 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
0.00%
0/135 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
Other adverse events
| Measure |
Esmirtazapine 1.5 mg In-treatment
n=137 participants at risk
Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
|
Esmirtazapine 3.0 mg In-Treatment
n=125 participants at risk
Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period.
|
Esmirtazapine 4.5 mg In-treatment
n=128 participants at risk
Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
|
Placebo In-treatment
n=135 participants at risk
Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period.
|
Esmirtazapine 1.5 mg Follow-up
n=137 participants at risk
After receiving 1.5 mg esmirtazipine in the In-Treatment Period, participants were followed for safety during a Follow-up Period in which no study medication was administered.
|
Esmirtazapine 3.0 mg Folow-up
n=125 participants at risk
After receiving 3.0 mg esmirtazipine in the In-Treatment Period, participants were followed for safety during a Follow-up Period in which no study medication was administered.
|
Esmirtazapine 4.5 mg Follow-up
n=128 participants at risk
After receiving 4.5 mg esmirtazipine in the In-Treatment Period, participants were followed for safety during a Follow-up Period in which no study medication was administered.
|
Placebo Follow-up
n=135 participants at risk
After receiving placebo in the In-Treatment Period, participants were followed for safety during a Follow-up Period in which no study medication was administered.
|
|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Somnolence
|
7.3%
10/137 • Number of events 10 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
8.8%
11/125 • Number of events 11 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
7.0%
9/128 • Number of events 9 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
1.5%
2/135 • Number of events 2 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
0.00%
0/137 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
0.00%
0/125 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
0.00%
0/128 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
0.00%
0/135 • From Day 1 of the Treatment Period up to 30 days after completion of the Treatment Period (up to 45 days). AE data were not reported for the 1 enrolled participant who did not receive study medication.
AEs were collected for 525 treated participants separately during the In-Treatment Period (Days 1-15) and during the Follow-up Period (up to Day 45).
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee All publications must be based on data validated and released by the Sponsor. Any such scientific paper, presentation, or other communication concerning the clinical trial will first be submitted to the Sponsor, at least 6 weeks ahead of estimated publication or presentation, for written consent, which shall not be withheld unreasonably.
- Publication restrictions are in place
Restriction type: OTHER