Trial Outcomes & Findings for An Investigational Drug Study In Patients With COPD (Chronic Obstructive Pulmonary Disease) (MK-0873-005) (NCT NCT00132730)
NCT ID: NCT00132730
Last Updated: 2018-10-12
Results Overview
FEV1 is a measure, in liters, of the amount of air expired in 1 second. Measured values were averaged during the placebo run-in period for baseline and over the last 4 weeks of the 12-week treatment period for on-treatment. For participants who did not have any measurements over the last 4 weeks of the 12-week treatment period, the last available on-treatment measurement was carried forward.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
604 participants
Primary outcome timeframe
Pre-dose at Baseline and Treatment Weeks 8, 10 and 12
Results posted on
2018-10-12
Participant Flow
Participant milestones
| Measure |
MK-0873 0.75 mg Base Study
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), and MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base)
|
MK-0873 1.25 mg Base Study
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), and MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base)
|
MK-0873 2.5 mg Base Study
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
|
Placebo Base Study
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
|
MK-0873 2.5 mg + Usual Care
Participants receive MK-0873 2.5 mg tablets once daily plus usual care (inhaled short- or long-acting beta-agonists, inhaled corticosteroids, or short- or long-acting anticholinergics) for 28 weeks in Periods IV and V (EXT2)
|
Usual Care
Participants receive usual care (inhaled short- or long-acting beta-agonists, inhaled corticosteroids, or short- or long-acting anticholinergics) for 28 weeks in Periods IV and V (EXT2)
|
|---|---|---|---|---|---|---|
|
Period I - Placebo Run-in (Base)
STARTED
|
150
|
148
|
153
|
153
|
0
|
0
|
|
Period I - Placebo Run-in (Base)
COMPLETED
|
150
|
148
|
153
|
153
|
0
|
0
|
|
Period I - Placebo Run-in (Base)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period II - 12-week Treatment (Base)
STARTED
|
150
|
148
|
153
|
153
|
0
|
0
|
|
Period II - 12-week Treatment (Base)
COMPLETED
|
127
|
133
|
135
|
131
|
0
|
0
|
|
Period II - 12-week Treatment (Base)
NOT COMPLETED
|
23
|
15
|
18
|
22
|
0
|
0
|
|
Period III - Blinded Extension (EXT1)
STARTED
|
0
|
0
|
317
|
107
|
0
|
0
|
|
Period III - Blinded Extension (EXT1)
COMPLETED
|
0
|
0
|
235
|
82
|
0
|
0
|
|
Period III - Blinded Extension (EXT1)
NOT COMPLETED
|
0
|
0
|
82
|
25
|
0
|
0
|
|
Period IV - Open-label Extension (EXT2)
STARTED
|
0
|
0
|
0
|
0
|
187
|
71
|
|
Period IV - Open-label Extension (EXT2)
COMPLETED
|
0
|
0
|
0
|
0
|
8
|
3
|
|
Period IV - Open-label Extension (EXT2)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
179
|
68
|
|
Period V - Open-label Extension (EXT2)
STARTED
|
0
|
0
|
0
|
0
|
7
|
2
|
|
Period V - Open-label Extension (EXT2)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period V - Open-label Extension (EXT2)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
7
|
2
|
Reasons for withdrawal
| Measure |
MK-0873 0.75 mg Base Study
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), and MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base)
|
MK-0873 1.25 mg Base Study
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), and MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base)
|
MK-0873 2.5 mg Base Study
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
|
Placebo Base Study
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
|
MK-0873 2.5 mg + Usual Care
Participants receive MK-0873 2.5 mg tablets once daily plus usual care (inhaled short- or long-acting beta-agonists, inhaled corticosteroids, or short- or long-acting anticholinergics) for 28 weeks in Periods IV and V (EXT2)
|
Usual Care
Participants receive usual care (inhaled short- or long-acting beta-agonists, inhaled corticosteroids, or short- or long-acting anticholinergics) for 28 weeks in Periods IV and V (EXT2)
|
|---|---|---|---|---|---|---|
|
Period II - 12-week Treatment (Base)
Clinical adverse experience
|
11
|
4
|
9
|
9
|
0
|
0
|
|
Period II - 12-week Treatment (Base)
Laboratory adverse experience
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Period II - 12-week Treatment (Base)
Other reasons
|
11
|
10
|
9
|
13
|
0
|
0
|
|
Period III - Blinded Extension (EXT1)
Site terminated
|
0
|
0
|
57
|
20
|
0
|
0
|
|
Period III - Blinded Extension (EXT1)
Clinical adverse experience
|
0
|
0
|
11
|
1
|
0
|
0
|
|
Period III - Blinded Extension (EXT1)
Laboratory adverse experience
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Period III - Blinded Extension (EXT1)
Other reasons
|
0
|
0
|
14
|
3
|
0
|
0
|
|
Period IV - Open-label Extension (EXT2)
Site terminated
|
0
|
0
|
0
|
0
|
169
|
68
|
|
Period IV - Open-label Extension (EXT2)
Clinical adverse experience
|
0
|
0
|
0
|
0
|
3
|
0
|
|
Period IV - Open-label Extension (EXT2)
Laboratory adverse experience
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Period IV - Open-label Extension (EXT2)
Other reasons
|
0
|
0
|
0
|
0
|
6
|
0
|
|
Period V - Open-label Extension (EXT2)
Site terminated
|
0
|
0
|
0
|
0
|
7
|
2
|
Baseline Characteristics
An Investigational Drug Study In Patients With COPD (Chronic Obstructive Pulmonary Disease) (MK-0873-005)
Baseline characteristics by cohort
| Measure |
MK-0873 0.75 mg Base Study
n=150 Participants
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
|
MK-0873 1.25 mg Base Study
n=148 Participants
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
|
MK-0873 2.5 mg Base Study
n=153 Participants
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
|
Placebo Base Study
n=153 Participants
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
|
Total
n=604 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
|
150 participants
n=93 Participants
|
148 participants
n=4 Participants
|
153 participants
n=27 Participants
|
153 participants
n=483 Participants
|
604 participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=93 Participants
|
45 Participants
n=4 Participants
|
45 Participants
n=27 Participants
|
41 Participants
n=483 Participants
|
167 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
114 Participants
n=93 Participants
|
103 Participants
n=4 Participants
|
108 Participants
n=27 Participants
|
112 Participants
n=483 Participants
|
437 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Pre-dose at Baseline and Treatment Weeks 8, 10 and 12Population: The modified intention-to-treat (ITT) population includes all participants who had a baseline and at least one posttreatment measurement.
FEV1 is a measure, in liters, of the amount of air expired in 1 second. Measured values were averaged during the placebo run-in period for baseline and over the last 4 weeks of the 12-week treatment period for on-treatment. For participants who did not have any measurements over the last 4 weeks of the 12-week treatment period, the last available on-treatment measurement was carried forward.
Outcome measures
| Measure |
MK-0873 0.75 mg Base Study
n=147 Participants
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
|
MK-0873 1.25 mg Base Study
n=143 Participants
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
|
MK-0873 2.5 mg Base Study
n=153 Participants
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
|
Placebo Base Study
n=152 Participants
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
|
|---|---|---|---|---|
|
Change From Baseline in Pre-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1)
|
-0.005 liters
Interval -0.032 to 0.023
|
-0.037 liters
Interval -0.065 to -0.009
|
-0.015 liters
Interval -0.043 to 0.012
|
-0.010 liters
Interval -0.038 to 0.017
|
SECONDARY outcome
Timeframe: Baseline and Treatment Weeks 8, 10 and 12Population: The modified ITT population includes all participants who had a baseline and at least one posttreatment measurement.
On a daily diary card, participants rated their responses to the question "Overall, how much of the time did you have symptoms from your lung disease today?" (0=none of the time; 5=all of the time). Scores range from 0 to 5, with higher scores indicating more time with symptoms. The overall daytime symptoms score value was the mean daily diary score during the placebo run-in period for baseline and over the last 4 weeks of the 12-week treatment period for on-treatment.
Outcome measures
| Measure |
MK-0873 0.75 mg Base Study
n=145 Participants
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
|
MK-0873 1.25 mg Base Study
n=144 Participants
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
|
MK-0873 2.5 mg Base Study
n=149 Participants
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
|
Placebo Base Study
n=148 Participants
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
|
|---|---|---|---|---|
|
Change From Baseline in Overall Daytime Symptoms Score
|
-0.15 score on a scale
Interval -0.24 to -0.06
|
-0.11 score on a scale
Interval -0.21 to -0.02
|
-0.13 score on a scale
Interval -0.22 to -0.04
|
-0.14 score on a scale
Interval -0.23 to -0.05
|
SECONDARY outcome
Timeframe: Baseline and Treatment Weeks 8, 10 and 12Population: The modified ITT population includes all participants who had a baseline and at least one posttreatment measurement.
The total daily beta-agonist use was measured in puffs per day and was recorded on daily diary cards by participants. It is defined as the sum of beta-agonist use between when participants arose from and went to bed. The total daily beta-agonist use values were the recorded mean during the placebo run-in period for baseline and over the last 4 weeks of the 12-week treatment period for on-treatment.
Outcome measures
| Measure |
MK-0873 0.75 mg Base Study
n=141 Participants
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
|
MK-0873 1.25 mg Base Study
n=140 Participants
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
|
MK-0873 2.5 mg Base Study
n=146 Participants
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
|
Placebo Base Study
n=145 Participants
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
|
|---|---|---|---|---|
|
Change From Baseline in Total Daily Beta-agonist Use
|
-0.04 Puffs per day of beta-agonist
Interval -0.45 to 0.38
|
-0.14 Puffs per day of beta-agonist
Interval -0.56 to 0.27
|
0.04 Puffs per day of beta-agonist
Interval -0.38 to 0.46
|
0.07 Puffs per day of beta-agonist
Interval -0.35 to 0.48
|
SECONDARY outcome
Timeframe: Baseline and Treatment Weeks 8 and 12Population: The modified ITT population includes all participants who had a baseline and at least one posttreatment measurement.
The SGRQ consists of 76 items in 3 domains: Symptoms (frequency and severity), Activity (activities that cause or are limited by breathlessness) and Impacts (social functioning, psychological disturbances resulting from airways disease). Scores for each domain and a total score are calculated; each questionnaire response has a unique empirically dervied "weight". Scores range from 0 to 100, with higher scores indicating poor health. Each domain of the questionnaire is scored separately in 2 steps: 1) The weights for all items with a positive response are summed; 2) The score is calculated by dividing the summed weights by the maximum possible weight for that domain and expressing the results as a percentage. The mean SGRQ scores were calculated during the placebo run-in period for baseline and over the last 4 weeks of the 12-week treatment period for on-treatment.
Outcome measures
| Measure |
MK-0873 0.75 mg Base Study
n=141 Participants
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
|
MK-0873 1.25 mg Base Study
n=140 Participants
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
|
MK-0873 2.5 mg Base Study
n=144 Participants
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
|
Placebo Base Study
n=143 Participants
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
|
|---|---|---|---|---|
|
Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Response
|
-2.92 score on a scale
Interval -4.69 to -1.16
|
-3.26 score on a scale
Interval -5.03 to -1.49
|
-2.08 score on a scale
Interval -3.85 to -0.31
|
-3.22 score on a scale
Interval -4.99 to -1.46
|
SECONDARY outcome
Timeframe: Baseline and Treatment Week 12Population: The modified ITT population includes all participants who had a baseline and at least one posttreatment measurement.
The baseline dyspnea index (BDI) was measured at the randomization visit as a 3-domain score with a scale of 0 to 4 in each domain, with a total focal score of 12 indicating no dyspnea limitation and 0 indicating severe dyspnea. After 12 weeks of treatment, the investigator-administered TDI was completed, with a change in each of the 3 domains being rated from -3 (major deterioration) to +3 (major improvement), so that the TDI focal score could range from -9 to +9. A higher TDI focal score indicates improvement.
Outcome measures
| Measure |
MK-0873 0.75 mg Base Study
n=138 Participants
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
|
MK-0873 1.25 mg Base Study
n=140 Participants
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
|
MK-0873 2.5 mg Base Study
n=141 Participants
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
|
Placebo Base Study
n=137 Participants
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
|
|---|---|---|---|---|
|
Transition Dyspnea Index (TDI) Focal Score
|
1.41 score on a scale
95% Confidence Interval 3.04 • Interval 0.95 to 1.88
|
1.49 score on a scale
95% Confidence Interval 3.07 • Interval 1.03 to 1.94
|
1.41 score on a scale
95% Confidence Interval 2.55 • Interval 0.95 to 1.87
|
1.66 score on a scale
95% Confidence Interval 2.73 • Interval 1.2 to 2.12
|
SECONDARY outcome
Timeframe: Baseline and Treatment Weeks 8 and 12Population: The modified ITT population includes all participants who had a baseline and at least one posttreatment measurement.
The SOBQ is a validated 24-item measure of dyspnea associated with activities of daily living in patients with moderate to severe chronic lung disease. Twenty-one items ask patients about how frequently they experience shortness of breath (SOB) on a 6-point scale of 0 (never) to 5 (activity given up due to dyspnea) when performing various tasks. Three additional questions about limitations due to SOB, fear of harm from overexertion and fear of SOB are included for a total of 24 items. If patients do not routinely perform the activity indicated in the questionnaire, they are asked to estimate the degree of SOB anticipated. The SOBQ total score is calculated by summing responses across all 24 items. The total score ranges from 0 to 120, with a higher score indicating greater frequency of and limitations due to SOB. The score assessed at the baseline visit was used for the baseline score and the mean score assessed at Treatment Weeks 8 and 12 was used as the on-treatment score.
Outcome measures
| Measure |
MK-0873 0.75 mg Base Study
n=141 Participants
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
|
MK-0873 1.25 mg Base Study
n=140 Participants
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
|
MK-0873 2.5 mg Base Study
n=144 Participants
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
|
Placebo Base Study
n=143 Participants
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
|
|---|---|---|---|---|
|
Change From Baseline in Shortness of Breath Questionnaire (SOBQ) Response
|
-2.90 score on a scale
Interval -5.06 to -0.74
|
-3.12 score on a scale
Interval -5.29 to -0.96
|
-2.28 score on a scale
Interval -4.44 to -0.12
|
-1.08 score on a scale
Interval -3.24 to 1.07
|
SECONDARY outcome
Timeframe: Baseline through Treatment Week 12Population: The modified ITT population includes all participants who had a baseline and at least one posttreatment measurement.
COPD exacerbation is defined as any change in symptoms or functional status that leads to administration (at investigator's discretion) of systemic corticosteroids (above participant's usual dose) and/or antibiotics, or an unscheduled COPD-related hospitalization, emergency room visit, or doctor visit. The number of participants who experienced at least one COPD exacerbation during the 12-week treatment period is reported.
Outcome measures
| Measure |
MK-0873 0.75 mg Base Study
n=150 Participants
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
|
MK-0873 1.25 mg Base Study
n=148 Participants
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
|
MK-0873 2.5 mg Base Study
n=153 Participants
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
|
Placebo Base Study
n=153 Participants
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
|
|---|---|---|---|---|
|
Number of Participants With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
|
37 participants
|
37 participants
|
33 participants
|
38 participants
|
SECONDARY outcome
Timeframe: Predose at Baseline and Treatment Weeks 8, 10 and 12Population: The modified ITT population includes all participants who had a baseline and at least one posttreatment measurement.
FVC is a measure, in liters and using a spirometer, of the amount of air forcibly exhaled from the lungs after taking the deepest breath possible. The values averaged during the placebo run-in period were used for the baseline measurement and the values averaged over Treatment Weeks 8, 10 and 12 were used for the on-treatment measurement. A higher value indicates greater lung exiratory function.
Outcome measures
| Measure |
MK-0873 0.75 mg Base Study
n=147 Participants
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
|
MK-0873 1.25 mg Base Study
n=143 Participants
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
|
MK-0873 2.5 mg Base Study
n=153 Participants
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
|
Placebo Base Study
n=152 Participants
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
|
|---|---|---|---|---|
|
Change From Baseline in Predose (Trough) Forced Vital Capacity (FVC)
|
0.008 liters
Interval -0.053 to 0.069
|
-0.082 liters
Interval -0.144 to -0.021
|
-0.002 liters
Interval -0.062 to 0.058
|
-0.069 liters
Interval -0.129 to -0.009
|
Adverse Events
MK-0873 0.75 mg Base Study
Serious events: 10 serious events
Other events: 47 other events
Deaths: 0 deaths
MK-0873 1.25 mg Base Study
Serious events: 11 serious events
Other events: 42 other events
Deaths: 0 deaths
MK-0873 2.5 mg Base Study
Serious events: 10 serious events
Other events: 66 other events
Deaths: 0 deaths
Placebo Base Study
Serious events: 6 serious events
Other events: 43 other events
Deaths: 0 deaths
MK-0873 2.5 mg EXT 1
Serious events: 17 serious events
Other events: 72 other events
Deaths: 0 deaths
Placebo EXT 1
Serious events: 4 serious events
Other events: 19 other events
Deaths: 0 deaths
MK-0873 2.5 mg + Usual Care EXT 2
Serious events: 9 serious events
Other events: 37 other events
Deaths: 0 deaths
Usual Care EXT2
Serious events: 5 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MK-0873 0.75 mg Base Study
n=150 participants at risk
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), and MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base)
|
MK-0873 1.25 mg Base Study
n=148 participants at risk
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), and MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base)
|
MK-0873 2.5 mg Base Study
n=153 participants at risk
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
|
Placebo Base Study
n=153 participants at risk
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
|
MK-0873 2.5 mg EXT 1
n=317 participants at risk
Participants receive MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
|
Placebo EXT 1
n=107 participants at risk
Participants receive placebo tablets once daily for 12 weeks in Period III (EXT1)
|
MK-0873 2.5 mg + Usual Care EXT 2
n=187 participants at risk
Participants receive MK-0873 2.5 mg tablets once daily plus usual care (inhaled short- or long-acting beta-agonists, inhaled corticosteroids, or short- or long-acting anticholinergics) for 28 weeks in Periods IV and V (EXT2)
|
Usual Care EXT2
n=71 participants at risk
Participants receive usual care (inhaled short- or long-acting beta-agonists, inhaled corticosteroids, or short- or long-acting anticholinergics) for 28 weeks in Periods IV and V (EXT2)
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.67%
1/150 • Number of events 1 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/148 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/317 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/107 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.53%
1/187 • Number of events 1 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/71 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/150 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/148 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/317 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/107 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/187 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
1.4%
1/71 • Number of events 1 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/150 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/148 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.65%
1/153 • Number of events 1 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/317 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/107 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/187 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/71 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/150 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/148 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/317 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/107 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.53%
1/187 • Number of events 1 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/71 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/150 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/148 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.32%
1/317 • Number of events 1 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/107 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/187 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/71 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/150 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/148 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.32%
1/317 • Number of events 1 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/107 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/187 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/71 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
|
Gastrointestinal disorders
Abdominal pain
|
0.67%
1/150 • Number of events 1 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/148 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/317 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/107 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/187 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/71 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/150 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/148 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.65%
1/153 • Number of events 1 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/317 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/107 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/187 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/71 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/150 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/148 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.65%
1/153 • Number of events 1 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/317 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/107 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/187 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/71 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/150 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/148 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.32%
1/317 • Number of events 1 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/107 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/187 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/71 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/150 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/148 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.65%
1/153 • Number of events 1 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/317 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/107 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/187 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/71 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
|
Gastrointestinal disorders
Rectal polyp
|
0.00%
0/150 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/148 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.65%
1/153 • Number of events 1 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/317 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/107 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/187 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/71 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
|
General disorders
Chest pain
|
0.00%
0/150 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/148 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.65%
1/153 • Number of events 2 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/317 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/107 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/187 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/71 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/150 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.68%
1/148 • Number of events 1 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.32%
1/317 • Number of events 1 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/107 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/187 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/71 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/150 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/148 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/317 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/107 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/187 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
1.4%
1/71 • Number of events 1 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/150 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.68%
1/148 • Number of events 1 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.32%
1/317 • Number of events 1 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/107 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/187 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/71 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/150 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/148 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.32%
1/317 • Number of events 1 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/107 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/187 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/71 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
|
Infections and infestations
Pneumonia
|
0.67%
1/150 • Number of events 1 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.68%
1/148 • Number of events 1 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.65%
1/153 • Number of events 1 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/317 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/107 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/187 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
1.4%
1/71 • Number of events 1 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/150 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/148 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/317 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.93%
1/107 • Number of events 1 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/187 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/71 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
2.0%
3/150 • Number of events 3 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
2.7%
4/148 • Number of events 4 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
2.6%
4/153 • Number of events 4 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.65%
1/153 • Number of events 1 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
1.3%
4/317 • Number of events 4 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
1.9%
2/107 • Number of events 2 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
1.6%
3/187 • Number of events 3 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/71 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/150 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.68%
1/148 • Number of events 1 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/317 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/107 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/187 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/71 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/150 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/148 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.32%
1/317 • Number of events 1 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/107 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/187 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/71 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/150 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/148 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.65%
1/153 • Number of events 1 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/317 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/107 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/187 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/71 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/150 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/148 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.65%
1/153 • Number of events 1 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/317 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/107 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/187 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/71 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.67%
1/150 • Number of events 1 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/148 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/317 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/107 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/187 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/71 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/150 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/148 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/317 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/107 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.53%
1/187 • Number of events 1 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/71 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/150 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/148 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.32%
1/317 • Number of events 1 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/107 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/187 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/71 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/150 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/148 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.65%
1/153 • Number of events 1 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/317 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/107 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/187 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/71 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage III
|
0.00%
0/150 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/148 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/317 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/107 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.53%
1/187 • Number of events 1 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/71 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/150 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.68%
1/148 • Number of events 1 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/317 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/107 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/187 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/71 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/150 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/148 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.32%
1/317 • Number of events 1 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/107 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/187 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/71 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/150 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/148 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.32%
1/317 • Number of events 1 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/107 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/187 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/71 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/150 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/148 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/317 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/107 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/187 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
1.4%
1/71 • Number of events 1 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.7%
4/150 • Number of events 4 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
1.4%
2/148 • Number of events 2 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
2.0%
3/153 • Number of events 3 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
1.3%
2/153 • Number of events 2 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
1.9%
6/317 • Number of events 6 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
1.9%
2/107 • Number of events 3 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
1.6%
3/187 • Number of events 3 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
2.8%
2/71 • Number of events 4 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/150 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.68%
1/148 • Number of events 1 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/317 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/107 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/187 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/71 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/150 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/148 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/153 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.32%
1/317 • Number of events 1 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/107 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/187 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/71 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
Other adverse events
| Measure |
MK-0873 0.75 mg Base Study
n=150 participants at risk
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), and MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base)
|
MK-0873 1.25 mg Base Study
n=148 participants at risk
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), and MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base)
|
MK-0873 2.5 mg Base Study
n=153 participants at risk
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
|
Placebo Base Study
n=153 participants at risk
Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
|
MK-0873 2.5 mg EXT 1
n=317 participants at risk
Participants receive MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
|
Placebo EXT 1
n=107 participants at risk
Participants receive placebo tablets once daily for 12 weeks in Period III (EXT1)
|
MK-0873 2.5 mg + Usual Care EXT 2
n=187 participants at risk
Participants receive MK-0873 2.5 mg tablets once daily plus usual care (inhaled short- or long-acting beta-agonists, inhaled corticosteroids, or short- or long-acting anticholinergics) for 28 weeks in Periods IV and V (EXT2)
|
Usual Care EXT2
n=71 participants at risk
Participants receive usual care (inhaled short- or long-acting beta-agonists, inhaled corticosteroids, or short- or long-acting anticholinergics) for 28 weeks in Periods IV and V (EXT2)
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
8.0%
12/150 • Number of events 15 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
4.7%
7/148 • Number of events 9 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
13.1%
20/153 • Number of events 29 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
2.0%
3/153 • Number of events 3 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
5.0%
16/317 • Number of events 17 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
2.8%
3/107 • Number of events 5 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
4.3%
8/187 • Number of events 9 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/71 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
|
Gastrointestinal disorders
Nausea
|
2.0%
3/150 • Number of events 3 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.68%
1/148 • Number of events 1 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
5.9%
9/153 • Number of events 9 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
2.0%
3/153 • Number of events 3 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
1.6%
5/317 • Number of events 5 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/107 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
1.1%
2/187 • Number of events 2 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
0.00%
0/71 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
|
Infections and infestations
Nasopharyngitis
|
7.3%
11/150 • Number of events 13 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
9.5%
14/148 • Number of events 21 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
12.4%
19/153 • Number of events 22 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
8.5%
13/153 • Number of events 16 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
5.7%
18/317 • Number of events 22 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
3.7%
4/107 • Number of events 4 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
8.6%
16/187 • Number of events 21 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
5.6%
4/71 • Number of events 4 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
19.3%
29/150 • Number of events 34 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
17.6%
26/148 • Number of events 30 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
20.9%
32/153 • Number of events 42 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
18.3%
28/153 • Number of events 35 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
12.6%
40/317 • Number of events 52 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
12.1%
13/107 • Number of events 15 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
9.6%
18/187 • Number of events 21 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
9.9%
7/71 • Number of events 8 • Up to 14 weeks in the Base Study; up to 14 weeks in study EXT1; up to 80 weeks in study EXT2
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation.
- Publication restrictions are in place
Restriction type: OTHER