Trial Outcomes & Findings for Acute Effects of Preladenant (SCH 420814) on Dyskinesia and Parkinsonism in Levodopa Treated Participants (P05550) (NCT NCT00845000)
NCT ID: NCT00845000
Last Updated: 2018-11-07
Results Overview
Dyskinesia was scored on a scale of 0 (absent), 1 (mild) , 2 (moderate), 3 (severe) and 4 (incapacitating) for seven body parts (face, neck, trunk, each arm and each leg) based on the worse dyskinesia noted during the entire measurement time. Scores were assessed at Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0. The dyskinesia score was the sum of the scores for the seven body parts. The peak dyskinesia score was recorded for each participant regardless of what timepoint the score was achieved. The total possible score for an individual at each timepoint could range from 0 to 28 with higher scores indicating greater effects of the dyskinesia. The mean peak dyskinesia score was calculated using the individual peak values.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 of each treatment period
Results posted on
2018-11-07
Participant Flow
Participant milestones
| Measure |
SCH 420814 10 mg→SCH 420814 100 mg→Placebo
Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
|
SCH 420814 100 mg→Placebo→ SCH 420814 10 mg
Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
|
Placebo→SCH 420814 10 mg→SCH 420814 100 mg
Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
|
SCH 420814 10 mg→ Placebo→ SCH 420814 100 mg
Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
|
SCH 420814 100 mg→ SCH 420814 10 mg→Placebo
Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
|
Placebo→ SCH 420814 100 mg→SCH 420814 10 mg
Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
|
|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Period 1
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2
STARTED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Period 2
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Period 3
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
2
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acute Effects of Preladenant (SCH 420814) on Dyskinesia and Parkinsonism in Levodopa Treated Participants (P05550)
Baseline characteristics by cohort
| Measure |
SCH 420814 10 mg→SCH 420814 100 mg→Placebo
n=2 Participants
Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
|
SCH 420814 100 mg→Placebo→ SCH 420814 10 mg
n=2 Participants
Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
|
Placebo→SCH 420814 10 mg→SCH 420814 100 mg
n=2 Participants
Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
|
SCH 420814 10 mg→ Placebo→ SCH 420814 100 mg
n=2 Participants
Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
|
SCH 420814 100 mg→ SCH 420814 10 mg→Placebo
n=2 Participants
Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
|
Placebo→ SCH 420814 100 mg→SCH 420814 10 mg
n=2 Participants
Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
57.5 Years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
59.5 Years
STANDARD_DEVIATION 3.5 • n=7 Participants
|
65.0 Years
STANDARD_DEVIATION 4.2 • n=5 Participants
|
63.5 Years
STANDARD_DEVIATION 6.4 • n=4 Participants
|
68.5 Years
STANDARD_DEVIATION 13.4 • n=21 Participants
|
57.5 Years
STANDARD_DEVIATION 3.5 • n=10 Participants
|
61.9 Years
STANDARD_DEVIATION 6.7 • n=115 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 of each treatment periodPopulation: All participants who received at least 1 dose of study drug and had available data for endpoint. Results pooled by study drug and not by randomly assigned sequence.
Dyskinesia was scored on a scale of 0 (absent), 1 (mild) , 2 (moderate), 3 (severe) and 4 (incapacitating) for seven body parts (face, neck, trunk, each arm and each leg) based on the worse dyskinesia noted during the entire measurement time. Scores were assessed at Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0. The dyskinesia score was the sum of the scores for the seven body parts. The peak dyskinesia score was recorded for each participant regardless of what timepoint the score was achieved. The total possible score for an individual at each timepoint could range from 0 to 28 with higher scores indicating greater effects of the dyskinesia. The mean peak dyskinesia score was calculated using the individual peak values.
Outcome measures
| Measure |
SCH 420814 10 mg
n=12 Participants
Participants who received single oral dose of SCH 420814 10 mg in either period 1, 2, or 3 regardless of randomly assigned treatment sequence
|
SCH 420814 100 mg
n=12 Participants
Participants who received single oral dose of SCH 420814 100 mg (four 25 mg capsules) in either period 1, 2, or 3 regardless of randomly assigned treatment
|
Placebo
n=12 Participants
Participants who received placebo in either period 1, 2, or 3 regardless of randomly assigned treatment
|
|---|---|---|---|
|
Mean Peak Dyskinesia Score
|
11.00 Score on a scale
Standard Deviation 5.15
|
11.42 Score on a scale
Standard Deviation 5.81
|
8.50 Score on a scale
Standard Deviation 3.92
|
SECONDARY outcome
Timeframe: Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 of each treatment periodPopulation: All participants who received at least 1 dose of study drug and had available data for endpoint. Results pooled by study drug and not by randomly assigned sequence.
Tapping was measured with two manual counters with keys that were depressed to register a count. The participant alternately tapped each counter using the index finger of the more affected hand for 60 seconds and was not allowed to use more than one finger to tap. The participant was instructed to tap as rapidly as possible while being timed for 60 seconds. The counts were recorded for the two counters at Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0. The peak tapping score was recorded for each participant regardless of what timepoint the score was achieved. The mean peak finger tapping score was calculated using the individual peak values.
Outcome measures
| Measure |
SCH 420814 10 mg
n=12 Participants
Participants who received single oral dose of SCH 420814 10 mg in either period 1, 2, or 3 regardless of randomly assigned treatment sequence
|
SCH 420814 100 mg
n=12 Participants
Participants who received single oral dose of SCH 420814 100 mg (four 25 mg capsules) in either period 1, 2, or 3 regardless of randomly assigned treatment
|
Placebo
n=12 Participants
Participants who received placebo in either period 1, 2, or 3 regardless of randomly assigned treatment
|
|---|---|---|---|
|
Mean Peak Finger Tapping Score
|
44.33 taps per 60 seconds
Standard Deviation 27.76
|
41.58 taps per 60 seconds
Standard Deviation 22.31
|
45.75 taps per 60 seconds
Standard Deviation 28.26
|
SECONDARY outcome
Timeframe: Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 of each treatment periodPopulation: All participants who received at least 1 dose of study drug and had available data for endpoint. Results pooled by study drug and not by randomly assigned sequence.
Tremor was scored on a scale of 0 (absent), 1 (mild, 2 (moderate), 3 (severe) and 4 (incapacitating) for seven body parts (face, neck, trunk, each arm and each leg) based on the worse tremor observed during the time spent with participant while taking other study measurements(vital signs, drawing samples, performing the tapping and walking tasks). Scores were assessed at Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0. The tremor score was the sum of scores for seven body parts. The peak tremor score was recorded for each participant regardless of what timepoint the score was achieved. The total possible score for an individual at each timepoint could range from 0 to 28 with higher scores indicating more effects of the tremors. The mean peak tremor score was calculated using the individual peak values.
Outcome measures
| Measure |
SCH 420814 10 mg
n=12 Participants
Participants who received single oral dose of SCH 420814 10 mg in either period 1, 2, or 3 regardless of randomly assigned treatment sequence
|
SCH 420814 100 mg
n=12 Participants
Participants who received single oral dose of SCH 420814 100 mg (four 25 mg capsules) in either period 1, 2, or 3 regardless of randomly assigned treatment
|
Placebo
n=12 Participants
Participants who received placebo in either period 1, 2, or 3 regardless of randomly assigned treatment
|
|---|---|---|---|
|
Mean Peak Tremor Score
|
3.5 Score on a scale
Standard Deviation 4.76
|
3.33 Score on a scale
Standard Deviation 4.66
|
4.42 Score on a scale
Standard Deviation 5.30
|
SECONDARY outcome
Timeframe: Hours 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 of each treatment periodPopulation: All participants who received at least 1 dose of study drug and had available data for endpoint. Results pooled by study drug and not by randomly assigned sequence.
Walking speed assessment began with the participant being seated in an armless chair. Then while being timed, the participant stood up with their arms crossed on their chest and walked 6 meters, turned around, returned to the chair and sat. Timing was stopped when the participant's buttocks hit the chair and the total time was recorded. If the participant could not arise in 60 seconds, 60 seconds was entered in this line of the report form and the participant was tested again but allowed to push off to get out of the chair. Sixty seconds was the maximum time allowed to complete the walking assessment, thus 60 seconds was recorded as the time if they could not complete the task within this time limit. Walking speed was assessed at Hours 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7.0 and 8. The peak walking speed was recorded for each participant regardless of what timepoint the score was achieved. The mean peak walking speed was calculated using the individual peak values.
Outcome measures
| Measure |
SCH 420814 10 mg
n=12 Participants
Participants who received single oral dose of SCH 420814 10 mg in either period 1, 2, or 3 regardless of randomly assigned treatment sequence
|
SCH 420814 100 mg
n=12 Participants
Participants who received single oral dose of SCH 420814 100 mg (four 25 mg capsules) in either period 1, 2, or 3 regardless of randomly assigned treatment
|
Placebo
n=12 Participants
Participants who received placebo in either period 1, 2, or 3 regardless of randomly assigned treatment
|
|---|---|---|---|
|
Mean Peak Walking Speed
|
16.64 Seconds
Standard Deviation 18.98
|
14.45 Seconds
Standard Deviation 15.73
|
20.00 Seconds
Standard Deviation 20.64
|
Adverse Events
SCH 420814 10 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
SCH 420814 100 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SCH 420814 10 mg
n=12 participants at risk
Participants who received single oral dose of SCH 420814 10 mg in either period 1, 2, or 3 regardless of randomly assigned treatment sequence
|
SCH 420814 100 mg
n=12 participants at risk
Participants who received single oral dose of SCH 420814 100 mg (four 25 mg capsules) in either period 1, 2, or 3 regardless of randomly assigned treatment
|
Placebo
n=12 participants at risk
Participants who received single oral dose of placebo in either period 1, 2, or 3 regardless of randomly assigned treatment
|
|---|---|---|---|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
8.3%
1/12 • Number of events 1 • up to 70 days (up to 14 days after last dose of study drug)
Safety population included all participants who received at least 1 dose of study drug. Adverse events are reported by study drug administered at time of the event and not by randomly assigned sequence.
|
0.00%
0/12 • up to 70 days (up to 14 days after last dose of study drug)
Safety population included all participants who received at least 1 dose of study drug. Adverse events are reported by study drug administered at time of the event and not by randomly assigned sequence.
|
0.00%
0/12 • up to 70 days (up to 14 days after last dose of study drug)
Safety population included all participants who received at least 1 dose of study drug. Adverse events are reported by study drug administered at time of the event and not by randomly assigned sequence.
|
|
General disorders
INFUSION SITE EXTRAVASATION
|
0.00%
0/12 • up to 70 days (up to 14 days after last dose of study drug)
Safety population included all participants who received at least 1 dose of study drug. Adverse events are reported by study drug administered at time of the event and not by randomly assigned sequence.
|
8.3%
1/12 • Number of events 1 • up to 70 days (up to 14 days after last dose of study drug)
Safety population included all participants who received at least 1 dose of study drug. Adverse events are reported by study drug administered at time of the event and not by randomly assigned sequence.
|
0.00%
0/12 • up to 70 days (up to 14 days after last dose of study drug)
Safety population included all participants who received at least 1 dose of study drug. Adverse events are reported by study drug administered at time of the event and not by randomly assigned sequence.
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/12 • up to 70 days (up to 14 days after last dose of study drug)
Safety population included all participants who received at least 1 dose of study drug. Adverse events are reported by study drug administered at time of the event and not by randomly assigned sequence.
|
0.00%
0/12 • up to 70 days (up to 14 days after last dose of study drug)
Safety population included all participants who received at least 1 dose of study drug. Adverse events are reported by study drug administered at time of the event and not by randomly assigned sequence.
|
8.3%
1/12 • Number of events 1 • up to 70 days (up to 14 days after last dose of study drug)
Safety population included all participants who received at least 1 dose of study drug. Adverse events are reported by study drug administered at time of the event and not by randomly assigned sequence.
|
|
Injury, poisoning and procedural complications
THERMAL BURN
|
8.3%
1/12 • Number of events 1 • up to 70 days (up to 14 days after last dose of study drug)
Safety population included all participants who received at least 1 dose of study drug. Adverse events are reported by study drug administered at time of the event and not by randomly assigned sequence.
|
0.00%
0/12 • up to 70 days (up to 14 days after last dose of study drug)
Safety population included all participants who received at least 1 dose of study drug. Adverse events are reported by study drug administered at time of the event and not by randomly assigned sequence.
|
0.00%
0/12 • up to 70 days (up to 14 days after last dose of study drug)
Safety population included all participants who received at least 1 dose of study drug. Adverse events are reported by study drug administered at time of the event and not by randomly assigned sequence.
|
|
Nervous system disorders
ATAXIA
|
0.00%
0/12 • up to 70 days (up to 14 days after last dose of study drug)
Safety population included all participants who received at least 1 dose of study drug. Adverse events are reported by study drug administered at time of the event and not by randomly assigned sequence.
|
0.00%
0/12 • up to 70 days (up to 14 days after last dose of study drug)
Safety population included all participants who received at least 1 dose of study drug. Adverse events are reported by study drug administered at time of the event and not by randomly assigned sequence.
|
8.3%
1/12 • Number of events 1 • up to 70 days (up to 14 days after last dose of study drug)
Safety population included all participants who received at least 1 dose of study drug. Adverse events are reported by study drug administered at time of the event and not by randomly assigned sequence.
|
|
Nervous system disorders
DYSKINESIA
|
8.3%
1/12 • Number of events 1 • up to 70 days (up to 14 days after last dose of study drug)
Safety population included all participants who received at least 1 dose of study drug. Adverse events are reported by study drug administered at time of the event and not by randomly assigned sequence.
|
16.7%
2/12 • Number of events 2 • up to 70 days (up to 14 days after last dose of study drug)
Safety population included all participants who received at least 1 dose of study drug. Adverse events are reported by study drug administered at time of the event and not by randomly assigned sequence.
|
0.00%
0/12 • up to 70 days (up to 14 days after last dose of study drug)
Safety population included all participants who received at least 1 dose of study drug. Adverse events are reported by study drug administered at time of the event and not by randomly assigned sequence.
|
|
Nervous system disorders
DYSTONIA
|
8.3%
1/12 • Number of events 1 • up to 70 days (up to 14 days after last dose of study drug)
Safety population included all participants who received at least 1 dose of study drug. Adverse events are reported by study drug administered at time of the event and not by randomly assigned sequence.
|
0.00%
0/12 • up to 70 days (up to 14 days after last dose of study drug)
Safety population included all participants who received at least 1 dose of study drug. Adverse events are reported by study drug administered at time of the event and not by randomly assigned sequence.
|
0.00%
0/12 • up to 70 days (up to 14 days after last dose of study drug)
Safety population included all participants who received at least 1 dose of study drug. Adverse events are reported by study drug administered at time of the event and not by randomly assigned sequence.
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/12 • up to 70 days (up to 14 days after last dose of study drug)
Safety population included all participants who received at least 1 dose of study drug. Adverse events are reported by study drug administered at time of the event and not by randomly assigned sequence.
|
8.3%
1/12 • Number of events 1 • up to 70 days (up to 14 days after last dose of study drug)
Safety population included all participants who received at least 1 dose of study drug. Adverse events are reported by study drug administered at time of the event and not by randomly assigned sequence.
|
0.00%
0/12 • up to 70 days (up to 14 days after last dose of study drug)
Safety population included all participants who received at least 1 dose of study drug. Adverse events are reported by study drug administered at time of the event and not by randomly assigned sequence.
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/12 • up to 70 days (up to 14 days after last dose of study drug)
Safety population included all participants who received at least 1 dose of study drug. Adverse events are reported by study drug administered at time of the event and not by randomly assigned sequence.
|
0.00%
0/12 • up to 70 days (up to 14 days after last dose of study drug)
Safety population included all participants who received at least 1 dose of study drug. Adverse events are reported by study drug administered at time of the event and not by randomly assigned sequence.
|
8.3%
1/12 • Number of events 1 • up to 70 days (up to 14 days after last dose of study drug)
Safety population included all participants who received at least 1 dose of study drug. Adverse events are reported by study drug administered at time of the event and not by randomly assigned sequence.
|
|
Vascular disorders
HYPERTENSION
|
33.3%
4/12 • Number of events 6 • up to 70 days (up to 14 days after last dose of study drug)
Safety population included all participants who received at least 1 dose of study drug. Adverse events are reported by study drug administered at time of the event and not by randomly assigned sequence.
|
16.7%
2/12 • Number of events 3 • up to 70 days (up to 14 days after last dose of study drug)
Safety population included all participants who received at least 1 dose of study drug. Adverse events are reported by study drug administered at time of the event and not by randomly assigned sequence.
|
8.3%
1/12 • Number of events 1 • up to 70 days (up to 14 days after last dose of study drug)
Safety population included all participants who received at least 1 dose of study drug. Adverse events are reported by study drug administered at 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 investigator agrees not to publish or publicly present any interim results of the trial without the prior written consent of the sponsor. The investigator further agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial.
- Publication restrictions are in place
Restriction type: OTHER