Trial Outcomes & Findings for A Study of MK-7145 Compared to Placebo and Hydrochlorothiazide for Lowering Blood Pressure in Male Participants With Hypertension (MK-7145-009) (NCT NCT01370655)
NCT ID: NCT01370655
Last Updated: 2018-09-21
Results Overview
Each participant had their blood pressure monitored by continuous 24-hour ambulatory blood pressure monitoring (ABPM) on Days -1 and 28 of each treatment period. The average systolic blood pressure over the 24-hour monitoring period was calculated for baseline (Day -1) and Day 28. The difference between baseline and Day 28 was calculated and recorded.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
46 participants
Primary outcome timeframe
Baseline and Day 28
Results posted on
2018-09-21
Participant Flow
Participants were randomly assigned to 1 of 12 treatment sequences Each 4-week treatment period was separated by a wash-out of approximately 4 weeks
Participant milestones
| Measure |
Treatment A → Treatment C
Participants received 6 mg MK-7145 for 4 weeks and then after a 4 week washout, received HCTZ 25 mg, daily, for 4 weeks
|
Treatment C → Treatment A
Participants received HCTZ 25 mg daily for 4 weeks and then after a 4-week washout, received 6 mg MK-7145 daily for 4 weeks.
|
Treatment A → Treatment D
Participants received 6 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received Placebo MK-7145 daily for 4 weeks.
|
Treatment D → Treatment A
Participants received Placebo MK-7145 daily for 4 weeks and then after a 4-week washout, received 6 mg MK-7145 daily for 4 weeks.
|
Treament D → Treatment C
Participants received Placebo MK-7145 daily for 4 weeks and then after a 4-week washout, received HCTZ 25 mg placebo daily for 4 weeks.
|
Treatment C → Treatment D
Participants received HCTZ 25 mg daily for 4 weeks and then after a 4-week washout, received Placebo MK-7145 daily for 4 weeks.
|
Treatment A → Treatment B
Participants received 6 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received 3 mg MK-7145 daily for 4 weeks.
|
Treatment B → Treatment A
Participants received 3 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received 6 mg MK-7145 daily for 4 weeks.
|
Treatment B → Treatment C
Participants received 3 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received HCTZ 25 mg daily for 4 weeks.
|
Treatment C → Treatment B
Participants received HCTZ 25 mg daily for 4 weeks and then after a 4-week washout, received 3 mg MK-7145 daily for 4 weeks.
|
Treatment B → Treatment D
Participants received 3 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received Placebo MK-715 daily for 4 weeks.
|
Treatment D → Treament B
Participants received Placebo MK-7145 daily for 4 weeks and then after a 4-week washout, received 3 mg MK-7145 daily for 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
7
|
7
|
3
|
3
|
3
|
4
|
4
|
4
|
3
|
2
|
3
|
3
|
|
Period 1
COMPLETED
|
5
|
7
|
3
|
3
|
3
|
4
|
3
|
4
|
3
|
2
|
3
|
3
|
|
Period 1
NOT COMPLETED
|
2
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Period 2
STARTED
|
5
|
7
|
3
|
3
|
3
|
4
|
3
|
4
|
3
|
2
|
3
|
3
|
|
Period 2
COMPLETED
|
5
|
7
|
1
|
3
|
2
|
4
|
2
|
3
|
1
|
2
|
2
|
3
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
2
|
0
|
1
|
0
|
1
|
1
|
2
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Treatment A → Treatment C
Participants received 6 mg MK-7145 for 4 weeks and then after a 4 week washout, received HCTZ 25 mg, daily, for 4 weeks
|
Treatment C → Treatment A
Participants received HCTZ 25 mg daily for 4 weeks and then after a 4-week washout, received 6 mg MK-7145 daily for 4 weeks.
|
Treatment A → Treatment D
Participants received 6 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received Placebo MK-7145 daily for 4 weeks.
|
Treatment D → Treatment A
Participants received Placebo MK-7145 daily for 4 weeks and then after a 4-week washout, received 6 mg MK-7145 daily for 4 weeks.
|
Treament D → Treatment C
Participants received Placebo MK-7145 daily for 4 weeks and then after a 4-week washout, received HCTZ 25 mg placebo daily for 4 weeks.
|
Treatment C → Treatment D
Participants received HCTZ 25 mg daily for 4 weeks and then after a 4-week washout, received Placebo MK-7145 daily for 4 weeks.
|
Treatment A → Treatment B
Participants received 6 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received 3 mg MK-7145 daily for 4 weeks.
|
Treatment B → Treatment A
Participants received 3 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received 6 mg MK-7145 daily for 4 weeks.
|
Treatment B → Treatment C
Participants received 3 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received HCTZ 25 mg daily for 4 weeks.
|
Treatment C → Treatment B
Participants received HCTZ 25 mg daily for 4 weeks and then after a 4-week washout, received 3 mg MK-7145 daily for 4 weeks.
|
Treatment B → Treatment D
Participants received 3 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received Placebo MK-715 daily for 4 weeks.
|
Treatment D → Treament B
Participants received Placebo MK-7145 daily for 4 weeks and then after a 4-week washout, received 3 mg MK-7145 daily for 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Period 1
Adverse Event
|
2
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Period 2
Adverse Event
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Period 2
met protocol specified stopping criteria
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
1
|
0
|
|
Period 2
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study of MK-7145 Compared to Placebo and Hydrochlorothiazide for Lowering Blood Pressure in Male Participants With Hypertension (MK-7145-009)
Baseline characteristics by cohort
| Measure |
Treatment A → Treatment C
n=7 Participants
Participants received 6 mg MK-7145 for 4 weeks and then after a 4 week washout, received HCTZ 25 mg, daily, for 4 weeks
|
Treatment C → Treatment A
n=7 Participants
Participants received HCTZ 25 mg daily for 4 weeks and then after a 4-week washout, received 6 mg MK-7145 daily for 4 weeks.
|
Treatment A → Treatment D
n=3 Participants
Participants received 6 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received Placebo MK-7145 daily for 4 weeks.
|
Treatment D → Treatment A
n=3 Participants
Participants received Placebo MK-7145 daily for 4 weeks and then after a 4-week washout, received 6 mg MK-7145 daily for 4 weeks.
|
Treament D → Treatment C
n=3 Participants
Participants received Placebo MK-7145 daily for 4 weeks and then after a 4-week washout, received HCTZ 25 mg placebo daily for 4 weeks.
|
Treatment C → Treatment D
n=4 Participants
Participants received HCTZ 25 mg daily for 4 weeks and then after a 4-week washout, received Placebo MK-7145 daily for 4 weeks.
|
Treatment A → Treatment B
n=4 Participants
Participants received 6 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received 3 mg MK-7145 daily for 4 weeks.
|
Treatment B → Treatment A
n=4 Participants
Participants received 3 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received 6 mg MK-7145 daily for 4 weeks.
|
Treatment B → Treatment C
n=3 Participants
Participants received 3 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received HCTZ 25 mg daily for 4 weeks.
|
Treatment C → Treatment B
n=2 Participants
Participants received HCTZ 25 mg daily for 4 weeks and then after a 4-week washout, received 3 mg MK-7145 daily for 4 weeks.
|
Treatment B → Treatment D
n=3 Participants
Participants received 3 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received Placebo MK-715 daily for 4 weeks.
|
Treatment D → Treament B
n=3 Participants
Participants received Placebo MK-7145 daily for 4 weeks and then after a 4-week washout, received 3 mg MK-7145 daily for 4 weeks.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
49.1 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
56.1 years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
58.3 years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
60.7 years
STANDARD_DEVIATION 3.2 • n=4 Participants
|
59.3 years
STANDARD_DEVIATION 8.3 • n=21 Participants
|
54.8 years
STANDARD_DEVIATION 14.7 • n=8 Participants
|
60.0 years
STANDARD_DEVIATION 6.7 • n=8 Participants
|
52.0 years
STANDARD_DEVIATION 9.6 • n=24 Participants
|
48.3 years
STANDARD_DEVIATION 12.6 • n=42 Participants
|
60.5 years
STANDARD_DEVIATION 6.4 • n=42 Participants
|
50.0 years
STANDARD_DEVIATION 1.0 • n=42 Participants
|
49.0 years
STANDARD_DEVIATION 9.2 • n=42 Participants
|
54.4 years
STANDARD_DEVIATION 9.2 • n=36 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
46 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 28Population: All participants who received at least 1 dose of study drug, complied with protocol sufficiently and had available data for endpoint. Participants are grouped by study drug taken at the time of the evaluation and not by randomly assigned sequence.
Each participant had their blood pressure monitored by continuous 24-hour ambulatory blood pressure monitoring (ABPM) on Days -1 and 28 of each treatment period. The average systolic blood pressure over the 24-hour monitoring period was calculated for baseline (Day -1) and Day 28. The difference between baseline and Day 28 was calculated and recorded.
Outcome measures
| Measure |
MK-7145 3 mg
n=17 Participants
Participants received 3 mg MK-7145 daily for 4 weeks
|
MK-7145 6 mg
n=25 Participants
Participants received 6 mg MK-7145 for 4 weeks
|
HCTZ 25 mg
n=21 Participants
Participants received HCTZ 25 mg daily for 4 weeks
|
Placebo
n=16 Participants
Participants received Placebo MK-7145 daily for 4 weeks
|
|---|---|---|---|---|
|
Change From Baseline in Time-weighted Average Over 24 Hours Post Dose (TWA [0-24]) in Systolic Blood Pressure (SBP)
|
-9.5 mmHg
Interval -12.7 to -6.4
|
-10.2 mmHg
Interval -12.8 to -7.6
|
-4.8 mmHg
Interval -7.6 to -1.9
|
-2.8 mmHg
Interval -6.1 to 0.4
|
PRIMARY outcome
Timeframe: Baseline and Day 28Population: All participants who received at least 1 dose of study drug, complied with protocol sufficiently and had available data for endpoint. Participants are grouped by study drug taken at the time of the evaluation and not by randomly assigned sequence.
Each participant had their blood pressure monitored by continuous 24-hour ambulatory blood pressure monitoring (ABPM) on Days -1 and 28 of each treatment period. The average diastolic blood pressure over the 24-hour monitoring period was calculated for baseline (Day -1) and Day 28. The difference between baseline and Day 28 was calculated and recorded.
Outcome measures
| Measure |
MK-7145 3 mg
n=17 Participants
Participants received 3 mg MK-7145 daily for 4 weeks
|
MK-7145 6 mg
n=25 Participants
Participants received 6 mg MK-7145 for 4 weeks
|
HCTZ 25 mg
n=21 Participants
Participants received HCTZ 25 mg daily for 4 weeks
|
Placebo
n=16 Participants
Participants received Placebo MK-7145 daily for 4 weeks
|
|---|---|---|---|---|
|
Change From Baseline in Time-weighted Average Over 24 Hours Post Dose (TWA [0-24]) in Diastolic Blood Pressure (DBP)
|
-4.5 mmHg
Interval -6.7 to -2.3
|
-4.3 mmHg
Interval -6.2 to -2.5
|
-1.5 mmHg
Interval -3.5 to 0.6
|
-1.1 mmHg
Interval -3.4 to 1.2
|
PRIMARY outcome
Timeframe: Baseline (Day-1) and Day 1Population: All participants who received at least 1 dose of study drug, complied with protocol sufficiently and had available data for endpoint. Participants are grouped by study drug taken at the time of the evaluation and not by randomly assigned sequence.
Urine sodium (Na) levels were measured over 24-hours on Day -1 (baseline) and on Day 1. The total amount of Na excreted in the urine for Day-1 (baseline) and Day1 were calculated and the difference between the 2 values was recorded.
Outcome measures
| Measure |
MK-7145 3 mg
n=17 Participants
Participants received 3 mg MK-7145 daily for 4 weeks
|
MK-7145 6 mg
n=25 Participants
Participants received 6 mg MK-7145 for 4 weeks
|
HCTZ 25 mg
n=21 Participants
Participants received HCTZ 25 mg daily for 4 weeks
|
Placebo
n=16 Participants
Participants received Placebo MK-7145 daily for 4 weeks
|
|---|---|---|---|---|
|
Change From Baseline in Urine Sodium at 24 Hours Post-dose on Day 1
|
0.4 mmol/day
Interval -31.0 to 31.7
|
46.0 mmol/day
Interval 20.3 to 71.7
|
64.1 mmol/day
Interval 36.6 to 91.6
|
-30.5 mmol/day
Interval -61.0 to -0.1
|
PRIMARY outcome
Timeframe: Up to 14 days post last dose of each treatment period (total of 6 weeks for each treatment period)Population: All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence.
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who experienced an AE during the study was summarized by study drug taken at the time of the AE.
Outcome measures
| Measure |
MK-7145 3 mg
n=19 Participants
Participants received 3 mg MK-7145 daily for 4 weeks
|
MK-7145 6 mg
n=28 Participants
Participants received 6 mg MK-7145 for 4 weeks
|
HCTZ 25 mg
n=26 Participants
Participants received HCTZ 25 mg daily for 4 weeks
|
Placebo
n=19 Participants
Participants received Placebo MK-7145 daily for 4 weeks
|
|---|---|---|---|---|
|
Percentage of Participants Who Experienced at Least 1 Adverse Event (AE)
|
84.2 Percentage of Participants
|
78.6 Percentage of Participants
|
73.1 Percentage of Participants
|
47.4 Percentage of Participants
|
PRIMARY outcome
Timeframe: up to 4 weeks of each treatment periodPopulation: All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence.
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who had the administration of the study drug discontinued during the study was summarized by study drug taken at the time of the AE. Participants may or may not have completed the study.
Outcome measures
| Measure |
MK-7145 3 mg
n=19 Participants
Participants received 3 mg MK-7145 daily for 4 weeks
|
MK-7145 6 mg
n=28 Participants
Participants received 6 mg MK-7145 for 4 weeks
|
HCTZ 25 mg
n=26 Participants
Participants received HCTZ 25 mg daily for 4 weeks
|
Placebo
n=19 Participants
Participants received Placebo MK-7145 daily for 4 weeks
|
|---|---|---|---|---|
|
Percentage of Participants Who Had Study Discontinued During the Study Due to an Adverse Event (AE)
|
0 Percentage of Participants
|
10.7 Percentage of Participants
|
7.7 Percentage of Participants
|
5.3 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 14 days post last dose of each treatment period (total of 6 weeks for each treatment period)Population: All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence.
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who experienced an AE that was reported as at least possibly-related to the study was summarized by study drug taken at the time of the AE.
Outcome measures
| Measure |
MK-7145 3 mg
n=19 Participants
Participants received 3 mg MK-7145 daily for 4 weeks
|
MK-7145 6 mg
n=28 Participants
Participants received 6 mg MK-7145 for 4 weeks
|
HCTZ 25 mg
n=26 Participants
Participants received HCTZ 25 mg daily for 4 weeks
|
Placebo
n=19 Participants
Participants received Placebo MK-7145 daily for 4 weeks
|
|---|---|---|---|---|
|
Percentage of Participants Who Experienced at Least 1 Drug-related Adverse Event (AE)
|
52.6 Percentage of Participants
|
42.9 Percentage of Participants
|
42.3 Percentage of Participants
|
26.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline (Day -1) and Day 28Population: All participants who received at least 1 dose of study drug, complied with protocol sufficiently and had available data for endpoint. Participants are grouped by study drug taken at the time of the evaluation and not by randomly assigned sequence.
Urine potassium (K+) levels were measured over 24-hours on Day -1 and on Day 28. The total amount of K+ excreted in the urine for Day-1 (baseline) and Day 28 were calculated and the difference between the 2 values was recorded.
Outcome measures
| Measure |
MK-7145 3 mg
n=17 Participants
Participants received 3 mg MK-7145 daily for 4 weeks
|
MK-7145 6 mg
n=25 Participants
Participants received 6 mg MK-7145 for 4 weeks
|
HCTZ 25 mg
n=21 Participants
Participants received HCTZ 25 mg daily for 4 weeks
|
Placebo
n=16 Participants
Participants received Placebo MK-7145 daily for 4 weeks
|
|---|---|---|---|---|
|
Change From Baseline in Urine Potassium at 24 Hours Post-dose on Day 28
|
0.3 mmol/day
Interval -9.2 to 9.8
|
-6.5 mmol/day
Interval -14.3 to 1.3
|
-2.7 mmol/day
Interval -11.3 to 6.0
|
-7.6 mmol/day
Interval -17.4 to 2.2
|
Adverse Events
MK-7145 3 mg
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
MK-7145 6 mg
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
HCTZ 25 mg
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MK-7145 3 mg
n=19 participants at risk
Participants received 3 mg MK-7145 daily for 4 weeks
|
MK-7145 6 mg
n=28 participants at risk
Participants received 6 mg MK-7145 for 4 weeks
|
HCTZ 25 mg
n=26 participants at risk
Participants received HCTZ 25 mg daily for 4 weeks
|
Placebo
n=19 participants at risk
Participants received Placebo MK-7145 daily for 4 weeks
|
|---|---|---|---|---|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/19 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
3.6%
1/28 • Number of events 1 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/26 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/19 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
|
Nervous system disorders
Migraine
|
0.00%
0/19 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/28 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
3.8%
1/26 • Number of events 1 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/19 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/19 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/28 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
3.8%
1/26 • Number of events 1 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/19 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
Other adverse events
| Measure |
MK-7145 3 mg
n=19 participants at risk
Participants received 3 mg MK-7145 daily for 4 weeks
|
MK-7145 6 mg
n=28 participants at risk
Participants received 6 mg MK-7145 for 4 weeks
|
HCTZ 25 mg
n=26 participants at risk
Participants received HCTZ 25 mg daily for 4 weeks
|
Placebo
n=19 participants at risk
Participants received Placebo MK-7145 daily for 4 weeks
|
|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
5.3%
1/19 • Number of events 1 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/28 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/26 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/19 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
|
Eye disorders
Eye pain
|
5.3%
1/19 • Number of events 1 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/28 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/26 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/19 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
|
Eye disorders
Vision blurred
|
5.3%
1/19 • Number of events 1 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
7.1%
2/28 • Number of events 2 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/26 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
5.3%
1/19 • Number of events 1 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.3%
1/19 • Number of events 1 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
3.6%
1/28 • Number of events 1 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/26 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/19 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
1/19 • Number of events 1 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
17.9%
5/28 • Number of events 9 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
11.5%
3/26 • Number of events 3 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
5.3%
1/19 • Number of events 1 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/19 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
10.7%
3/28 • Number of events 3 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/26 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/19 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/19 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
7.1%
2/28 • Number of events 2 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/26 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/19 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
|
Gastrointestinal disorders
Vomiting
|
10.5%
2/19 • Number of events 2 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
7.1%
2/28 • Number of events 3 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/26 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/19 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
|
General disorders
Fatigue
|
5.3%
1/19 • Number of events 1 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/28 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
3.8%
1/26 • Number of events 1 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/19 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
|
General disorders
Thirst
|
0.00%
0/19 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
10.7%
3/28 • Number of events 3 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/26 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
5.3%
1/19 • Number of events 1 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
|
Infections and infestations
Bronchitis
|
5.3%
1/19 • Number of events 1 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/28 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/26 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/19 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/19 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
21.4%
6/28 • Number of events 6 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
19.2%
5/26 • Number of events 5 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
5.3%
1/19 • Number of events 1 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/19 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/28 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/26 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
5.3%
1/19 • Number of events 5 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
|
Investigations
Blood aldosterone increased
|
5.3%
1/19 • Number of events 1 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/28 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
3.8%
1/26 • Number of events 1 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/19 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
|
Investigations
Blood potassium decreased
|
0.00%
0/19 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
7.1%
2/28 • Number of events 2 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/26 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/19 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
|
Investigations
Blood pressure systolic increased
|
5.3%
1/19 • Number of events 1 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/28 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/26 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
10.5%
2/19 • Number of events 2 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
|
Investigations
Blood uric acid increased
|
10.5%
2/19 • Number of events 8 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
14.3%
4/28 • Number of events 15 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
3.8%
1/26 • Number of events 1 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/19 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
|
Investigations
Weight decreased
|
0.00%
0/19 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
7.1%
2/28 • Number of events 2 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/26 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/19 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/19 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
3.6%
1/28 • Number of events 1 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
3.8%
1/26 • Number of events 1 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
10.5%
2/19 • Number of events 2 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
|
Nervous system disorders
Dizziness
|
5.3%
1/19 • Number of events 1 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
7.1%
2/28 • Number of events 5 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
3.8%
1/26 • Number of events 2 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/19 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
|
Nervous system disorders
Headache
|
26.3%
5/19 • Number of events 8 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
28.6%
8/28 • Number of events 10 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
23.1%
6/26 • Number of events 13 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
10.5%
2/19 • Number of events 3 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
|
Nervous system disorders
Presyncope
|
0.00%
0/19 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
7.1%
2/28 • Number of events 2 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
3.8%
1/26 • Number of events 1 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/19 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/19 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/28 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/26 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
5.3%
1/19 • Number of events 2 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
|
Renal and urinary disorders
Haematuria
|
5.3%
1/19 • Number of events 1 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/28 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/26 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
5.3%
1/19 • Number of events 1 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
|
Renal and urinary disorders
Polyuria
|
10.5%
2/19 • Number of events 2 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
7.1%
2/28 • Number of events 2 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
7.7%
2/26 • Number of events 2 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
10.5%
2/19 • Number of events 2 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/19 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
3.6%
1/28 • Number of events 1 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/26 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
5.3%
1/19 • Number of events 1 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.3%
1/19 • Number of events 1 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/28 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/26 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/19 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.3%
1/19 • Number of events 1 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/28 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/26 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/19 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
|
Respiratory, thoracic and mediastinal disorders
Nocturnal dyspnoea
|
5.3%
1/19 • Number of events 1 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
3.6%
1/28 • Number of events 1 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/26 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/19 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.3%
1/19 • Number of events 1 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/28 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/26 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
0.00%
0/19 • up to 14 days post last dose of study drug for each treatment period
All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence
|
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. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER