Trial Outcomes & Findings for Safety and Efficacy of MK0736 & MK0916 in Patients With Hypertension (High Blood Pressure)(0736-003)(COMPLETED) (NCT NCT00274716)
NCT ID: NCT00274716
Last Updated: 2015-07-03
Results Overview
Sitting diastolic blood pressure measured in triplicate at baseline and after 12 weeks of study drug administration. Mean value of the 3 measurements at the 2 timepoints was recorded.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
249 participants
Primary outcome timeframe
Baseline and Week 12 (end of Phase A)
Results posted on
2015-07-03
Participant Flow
Enrolled participants were divided into 2 strata: higher body mass index (BMI) (27 kg/m\^2≤BMI\<41 kg/m\^2) and lower BMI (20 kg/m\^2≤BMI\<27 kg/m\^2) prior to being randomly assigned study treatment. Data from High BMI groups were to be utilized in the primary and secondary analyses; data from low BMI groups were to be utilized in exploratory analyses.
Participant milestones
| Measure |
High BMI:MK-0736 2mg→Placebo
Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
|
High BMI:MK-0736 7mg→Placebo
Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
|
High BMI:MK-0916 6mg→MK-0916 6mg
Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
|
High BMI:Placebo→Placebo
Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
|
Low BMI:MK-0916 6mg→MK-0916 6mg
Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
|
Low BMI:Placebo→Placebo
Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
|
|---|---|---|---|---|---|---|
|
Phase A
STARTED
|
54
|
54
|
52
|
51
|
19
|
19
|
|
Phase A
COMPLETED
|
43
|
44
|
44
|
42
|
16
|
15
|
|
Phase A
NOT COMPLETED
|
11
|
10
|
8
|
9
|
3
|
4
|
|
Phase B
STARTED
|
43
|
44
|
44
|
42
|
16
|
15
|
|
Phase B
COMPLETED
|
42
|
40
|
41
|
41
|
16
|
14
|
|
Phase B
NOT COMPLETED
|
1
|
4
|
3
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
High BMI:MK-0736 2mg→Placebo
Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
|
High BMI:MK-0736 7mg→Placebo
Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
|
High BMI:MK-0916 6mg→MK-0916 6mg
Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
|
High BMI:Placebo→Placebo
Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
|
Low BMI:MK-0916 6mg→MK-0916 6mg
Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
|
Low BMI:Placebo→Placebo
Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
|
|---|---|---|---|---|---|---|
|
Phase A
Other non-reported reason
|
4
|
2
|
1
|
2
|
0
|
1
|
|
Phase A
Participant moved
|
0
|
0
|
1
|
0
|
0
|
1
|
|
Phase A
Site Terminated
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Phase A
Protocol Violation
|
1
|
0
|
0
|
1
|
0
|
0
|
|
Phase A
Met criteria for discontinuation
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Phase A
Withdrawal by Subject
|
2
|
2
|
1
|
3
|
0
|
1
|
|
Phase A
Adverse Event
|
2
|
3
|
3
|
0
|
2
|
0
|
|
Phase A
Completed but did not enter Phase B
|
1
|
2
|
2
|
2
|
1
|
1
|
|
Phase B
Adverse Event
|
0
|
0
|
2
|
0
|
0
|
1
|
|
Phase B
Protocol Violation
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Phase B
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Phase B
Participant moved
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Phase B
Other non-reported reason
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Phase B
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety and Efficacy of MK0736 & MK0916 in Patients With Hypertension (High Blood Pressure)(0736-003)(COMPLETED)
Baseline characteristics by cohort
| Measure |
High BMI:MK-0736 2mg→Placebo
n=54 Participants
Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
|
High BMI:MK-0736 7mg→Placebo
n=54 Participants
Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
|
High BMI:MK-0916 6mg→MK-0916 6mg
n=52 Participants
Participants who received MK-0916 6 mg in Phase A and continued on MK-0916 6 mg for 12 weeks in Phase B
|
High BMI:Placebo→Placebo
n=51 Participants
Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
|
Low BMI:MK-0916 6mg→MK-0916 6mg
n=19 Participants
Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
|
Low BMI:Placebo→Placebo
n=19 Participants
Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
|
Total
n=249 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
21 to 30 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
|
Age, Customized
31 to 40 years
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
12 Participants
n=3 Participants
|
|
Age, Customized
41 to 50 years
|
10 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
71 Participants
n=3 Participants
|
|
Age, Customized
51 to 60 years
|
26 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
9 Participants
n=30 Participants
|
101 Participants
n=3 Participants
|
|
Age, Customized
61 to 70 years
|
14 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
61 Participants
n=3 Participants
|
|
Age, Customized
>70 years
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
10 Participants
n=30 Participants
|
96 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
38 Participants
n=7 Participants
|
13 Participants
n=31 Participants
|
9 Participants
n=30 Participants
|
153 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12 (end of Phase A)Population: Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint.
Sitting diastolic blood pressure measured in triplicate at baseline and after 12 weeks of study drug administration. Mean value of the 3 measurements at the 2 timepoints was recorded.
Outcome measures
| Measure |
MK-0736 2.0 mg High BMI
n=53 Participants
Participants administered MK-0736 2.0 mg tablet once daily for 12 weeks
|
MK-0736 7.0 mg High BMI
n=52 Participants
Participants administered MK-0736 7.0 mg tablet once daily for 12 weeks
|
MK-0916 6.0 mg High BMI
n=49 Participants
Participants administered MK-0916 6.0 mg tablet once daily for 12 weeks
|
Placebo High BMI
n=51 Participants
Participants administered placebo tablet once daily for 12 weeks
|
Low BMI:MK-0916 6mg→MK-0916 6mg
Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
|
Low BMI:Placebo→Placebo
Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 in Participants With Higher Body Mass Indices (BMI)
|
-4.2 mm Hg
Standard Deviation 7.3
|
-2.4 mm Hg
Standard Deviation 8.1
|
-3.1 mm Hg
Standard Deviation 7.9
|
-0.2 mm Hg
Standard Deviation 8.7
|
—
|
—
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: All Patients as Treated (ApaT) population, defined as all randomized participants who received at least 1 dose of double-blind study therapy.
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S 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 is temporally associated with the use of the SPONSOR'S product, is also an AE. A clinical AE was an AE reported as a result of a clinical examination.
Outcome measures
| Measure |
MK-0736 2.0 mg High BMI
n=54 Participants
Participants administered MK-0736 2.0 mg tablet once daily for 12 weeks
|
MK-0736 7.0 mg High BMI
n=54 Participants
Participants administered MK-0736 7.0 mg tablet once daily for 12 weeks
|
MK-0916 6.0 mg High BMI
n=52 Participants
Participants administered MK-0916 6.0 mg tablet once daily for 12 weeks
|
Placebo High BMI
n=51 Participants
Participants administered placebo tablet once daily for 12 weeks
|
Low BMI:MK-0916 6mg→MK-0916 6mg
n=19 Participants
Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
|
Low BMI:Placebo→Placebo
n=19 Participants
Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Reported a Clinical Adverse Event
|
44 Participants
|
39 Participants
|
38 Participants
|
36 Participants
|
16 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: All Patients as Treated (ApaT) population, defined as all randomized participants who received at least 1 dose of double-blind study therapy.
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S 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 is temporally associated with the use of the SPONSOR'S product, is also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test.
Outcome measures
| Measure |
MK-0736 2.0 mg High BMI
n=54 Participants
Participants administered MK-0736 2.0 mg tablet once daily for 12 weeks
|
MK-0736 7.0 mg High BMI
n=54 Participants
Participants administered MK-0736 7.0 mg tablet once daily for 12 weeks
|
MK-0916 6.0 mg High BMI
n=52 Participants
Participants administered MK-0916 6.0 mg tablet once daily for 12 weeks
|
Placebo High BMI
n=51 Participants
Participants administered placebo tablet once daily for 12 weeks
|
Low BMI:MK-0916 6mg→MK-0916 6mg
n=19 Participants
Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
|
Low BMI:Placebo→Placebo
n=19 Participants
Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Reported a Laboratory Adverse Event
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: All Patients as Treated (ApaT) population, defined as all randomized participants who received at least 1 dose of double-blind study therapy.
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S 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 is temporally associated with the use of the SPONSOR'S product, is also an AE. A clinical AE was an AE reported as a result of a clinical examination.
Outcome measures
| Measure |
MK-0736 2.0 mg High BMI
n=54 Participants
Participants administered MK-0736 2.0 mg tablet once daily for 12 weeks
|
MK-0736 7.0 mg High BMI
n=54 Participants
Participants administered MK-0736 7.0 mg tablet once daily for 12 weeks
|
MK-0916 6.0 mg High BMI
n=52 Participants
Participants administered MK-0916 6.0 mg tablet once daily for 12 weeks
|
Placebo High BMI
n=51 Participants
Participants administered placebo tablet once daily for 12 weeks
|
Low BMI:MK-0916 6mg→MK-0916 6mg
n=19 Participants
Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
|
Low BMI:Placebo→Placebo
n=19 Participants
Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Were Discontinued From Study Due to Clinical Adverse Event
|
2 Participants
|
3 Participants
|
6 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: All Patients as Treated (ApaT) population, defined as all randomized participants who received at least 1 dose of double-blind study therapy.
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S 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 is temporally associated with the use of the SPONSOR'S product, is also an AE. A laboratory AE was an AE reported as a result of a laboratory assessment or test.
Outcome measures
| Measure |
MK-0736 2.0 mg High BMI
n=54 Participants
Participants administered MK-0736 2.0 mg tablet once daily for 12 weeks
|
MK-0736 7.0 mg High BMI
n=54 Participants
Participants administered MK-0736 7.0 mg tablet once daily for 12 weeks
|
MK-0916 6.0 mg High BMI
n=52 Participants
Participants administered MK-0916 6.0 mg tablet once daily for 12 weeks
|
Placebo High BMI
n=51 Participants
Participants administered placebo tablet once daily for 12 weeks
|
Low BMI:MK-0916 6mg→MK-0916 6mg
n=19 Participants
Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
|
Low BMI:Placebo→Placebo
n=19 Participants
Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Were Discontinued From Study Due to Laboratory Adverse Event
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12 (end of Phase A)Population: Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint.
Sitting systolic blood pressure measured in triplicate at baseline and after 12 weeks of study drug administration. Mean trough value of the 3 measurements at the 2 timepoints was recorded.
Outcome measures
| Measure |
MK-0736 2.0 mg High BMI
n=53 Participants
Participants administered MK-0736 2.0 mg tablet once daily for 12 weeks
|
MK-0736 7.0 mg High BMI
n=52 Participants
Participants administered MK-0736 7.0 mg tablet once daily for 12 weeks
|
MK-0916 6.0 mg High BMI
n=49 Participants
Participants administered MK-0916 6.0 mg tablet once daily for 12 weeks
|
Placebo High BMI
n=51 Participants
Participants administered placebo tablet once daily for 12 weeks
|
Low BMI:MK-0916 6mg→MK-0916 6mg
Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
|
Low BMI:Placebo→Placebo
Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12 in Participants With Higher Body Mass Indices (BMI)
|
-3.5 mm Hg
Standard Deviation 13.2
|
-4.2 mm Hg
Standard Deviation 12.9
|
-3.2 mm Hg
Standard Deviation 11.3
|
0.7 mm Hg
Standard Deviation 12.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12 (end of Phase A)Population: Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint.
Weight was measured in duplicate (2 measurements) at baseline and after 12 weeks of study drug administration. The mean of the 2 values at each assessment was used in analysis.
Outcome measures
| Measure |
MK-0736 2.0 mg High BMI
n=54 Participants
Participants administered MK-0736 2.0 mg tablet once daily for 12 weeks
|
MK-0736 7.0 mg High BMI
n=52 Participants
Participants administered MK-0736 7.0 mg tablet once daily for 12 weeks
|
MK-0916 6.0 mg High BMI
n=50 Participants
Participants administered MK-0916 6.0 mg tablet once daily for 12 weeks
|
Placebo High BMI
n=50 Participants
Participants administered placebo tablet once daily for 12 weeks
|
Low BMI:MK-0916 6mg→MK-0916 6mg
Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
|
Low BMI:Placebo→Placebo
Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Body Weight (kg) at Week 12 in Participants With Higher BMI
|
-0.6 kg
Standard Deviation 1.8
|
-0.9 kg
Standard Deviation 2.0
|
-1.2 kg
Standard Deviation 1.8
|
0.5 kg
Standard Deviation 1.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12 (end of Phase A)Population: Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint.
Waist circumference measured in cm at baseline and after 12 weeks of study drug administration
Outcome measures
| Measure |
MK-0736 2.0 mg High BMI
n=47 Participants
Participants administered MK-0736 2.0 mg tablet once daily for 12 weeks
|
MK-0736 7.0 mg High BMI
n=50 Participants
Participants administered MK-0736 7.0 mg tablet once daily for 12 weeks
|
MK-0916 6.0 mg High BMI
n=49 Participants
Participants administered MK-0916 6.0 mg tablet once daily for 12 weeks
|
Placebo High BMI
n=44 Participants
Participants administered placebo tablet once daily for 12 weeks
|
Low BMI:MK-0916 6mg→MK-0916 6mg
Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
|
Low BMI:Placebo→Placebo
Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Waist Circumference at Week 12 in Participants With Higher BMI
|
-1.9 cm
Standard Deviation 4.9
|
-0.9 cm
Standard Deviation 2.9
|
-0.3 cm
Standard Deviation 4.9
|
1.2 cm
Standard Deviation 6.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12 (end of Phase A)Population: Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint.
LDL-C was calculated by the method of Friedewald equation at baseline and after 12 weeks of study drug administration.
Outcome measures
| Measure |
MK-0736 2.0 mg High BMI
n=49 Participants
Participants administered MK-0736 2.0 mg tablet once daily for 12 weeks
|
MK-0736 7.0 mg High BMI
n=50 Participants
Participants administered MK-0736 7.0 mg tablet once daily for 12 weeks
|
MK-0916 6.0 mg High BMI
n=44 Participants
Participants administered MK-0916 6.0 mg tablet once daily for 12 weeks
|
Placebo High BMI
n=45 Participants
Participants administered placebo tablet once daily for 12 weeks
|
Low BMI:MK-0916 6mg→MK-0916 6mg
Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
|
Low BMI:Placebo→Placebo
Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 in Participants With Higher Body Mass Indices (BMI)
|
-1.0 percentage change
Standard Deviation 23.3
|
-5.2 percentage change
Standard Deviation 20.4
|
4.5 percentage change
Standard Deviation 23.0
|
5.7 percentage change
Standard Deviation 30.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12 (end of Phase A)Population: Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint.
HDL-C measured at baseline and after 12 weeks of study drug administration.
Outcome measures
| Measure |
MK-0736 2.0 mg High BMI
n=49 Participants
Participants administered MK-0736 2.0 mg tablet once daily for 12 weeks
|
MK-0736 7.0 mg High BMI
n=51 Participants
Participants administered MK-0736 7.0 mg tablet once daily for 12 weeks
|
MK-0916 6.0 mg High BMI
n=47 Participants
Participants administered MK-0916 6.0 mg tablet once daily for 12 weeks
|
Placebo High BMI
n=45 Participants
Participants administered placebo tablet once daily for 12 weeks
|
Low BMI:MK-0916 6mg→MK-0916 6mg
Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
|
Low BMI:Placebo→Placebo
Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
|
|---|---|---|---|---|---|---|
|
Change From Baseline for High Density Lipoprotein Cholesterol (HDL-C) at Week 12 in Participants With Higher BMI
|
-1.3 Percent change
Standard Deviation 5.7
|
-1.8 Percent change
Standard Deviation 6.7
|
1.6 Percent change
Standard Deviation 6.7
|
1.5 Percent change
Standard Deviation 5.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12 (end of Phase A)Population: Higher BMI participants in the All Patients Treated (APT) Population, which included all randomized participants who had valid efficacy measurements at baseline and at least once during the double-blind treatment period. The MK-0916 6.0 mg and Placebo Low BMI groups were not included in the planned analysis for this endpoint.
TG measured at baseline and after 12 weeks of study drug administration
Outcome measures
| Measure |
MK-0736 2.0 mg High BMI
n=49 Participants
Participants administered MK-0736 2.0 mg tablet once daily for 12 weeks
|
MK-0736 7.0 mg High BMI
n=51 Participants
Participants administered MK-0736 7.0 mg tablet once daily for 12 weeks
|
MK-0916 6.0 mg High BMI
n=47 Participants
Participants administered MK-0916 6.0 mg tablet once daily for 12 weeks
|
Placebo High BMI
n=45 Participants
Participants administered placebo tablet once daily for 12 weeks
|
Low BMI:MK-0916 6mg→MK-0916 6mg
Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
|
Low BMI:Placebo→Placebo
Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
|
|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Triglycerides (TG) at Week 12 in Participants With Higher Body Mass Indices (BMI)
|
11.5 Percent change
Standard Deviation 40.3
|
20.1 Percent change
Standard Deviation 54.9
|
11.6 Percent change
Standard Deviation 41.2
|
11.1 Percent change
Standard Deviation 40.2
|
—
|
—
|
Adverse Events
High BMI:MK-0736 2mg→Placebo
Serious events: 2 serious events
Other events: 40 other events
Deaths: 0 deaths
High BMI:MK-0736 7mg→Placebo
Serious events: 1 serious events
Other events: 39 other events
Deaths: 0 deaths
High BMI:MK-0916 6mg→MK-0916 6mg
Serious events: 2 serious events
Other events: 37 other events
Deaths: 0 deaths
High BMI:Placebo→Placebo
Serious events: 1 serious events
Other events: 37 other events
Deaths: 0 deaths
Low BMI:MK-0916 6mg→MK-0916 6mg
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Low BMI:Placebo→Placebo
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
High BMI:MK-0736 2mg→Placebo
n=54 participants at risk
Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
|
High BMI:MK-0736 7mg→Placebo
n=54 participants at risk
Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
|
High BMI:MK-0916 6mg→MK-0916 6mg
n=52 participants at risk
Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
|
High BMI:Placebo→Placebo
n=51 participants at risk
Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
|
Low BMI:MK-0916 6mg→MK-0916 6mg
n=19 participants at risk
Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
|
Low BMI:Placebo→Placebo
n=19 participants at risk
Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Hernia
|
1.9%
1/54 • 24 weeks
|
0.00%
0/54 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/51 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
|
Gastrointestinal disorders
Ileus
|
1.9%
1/54 • 24 weeks
|
0.00%
0/54 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/51 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
|
Immune system disorders
Anaphylactic Reaction
|
0.00%
0/54 • 24 weeks
|
1.9%
1/54 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/51 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/54 • 24 weeks
|
0.00%
0/54 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
2.0%
1/51 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
|
Infections and infestations
Meningitis Bacterial
|
0.00%
0/54 • 24 weeks
|
0.00%
0/54 • 24 weeks
|
1.9%
1/52 • 24 weeks
|
0.00%
0/51 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/54 • 24 weeks
|
0.00%
0/54 • 24 weeks
|
1.9%
1/52 • 24 weeks
|
0.00%
0/51 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Lichen Sclerosus
|
1.9%
1/54 • 24 weeks
|
0.00%
0/54 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/51 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/54 • 24 weeks
|
0.00%
0/54 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/51 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
5.3%
1/19 • 24 weeks
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/54 • 24 weeks
|
0.00%
0/54 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/51 • 24 weeks
|
5.3%
1/19 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
0.00%
0/54 • 24 weeks
|
0.00%
0/54 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/51 • 24 weeks
|
5.3%
1/19 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
Other adverse events
| Measure |
High BMI:MK-0736 2mg→Placebo
n=54 participants at risk
Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
|
High BMI:MK-0736 7mg→Placebo
n=54 participants at risk
Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
|
High BMI:MK-0916 6mg→MK-0916 6mg
n=52 participants at risk
Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
|
High BMI:Placebo→Placebo
n=51 participants at risk
Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
|
Low BMI:MK-0916 6mg→MK-0916 6mg
n=19 participants at risk
Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
|
Low BMI:Placebo→Placebo
n=19 participants at risk
Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
5.6%
3/54 • 24 weeks
|
0.00%
0/54 • 24 weeks
|
5.8%
3/52 • 24 weeks
|
3.9%
2/51 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
|
Gastrointestinal disorders
Nausea
|
3.7%
2/54 • 24 weeks
|
1.9%
1/54 • 24 weeks
|
7.7%
4/52 • 24 weeks
|
2.0%
1/51 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
5.3%
1/19 • 24 weeks
|
|
General disorders
Chest Pain
|
1.9%
1/54 • 24 weeks
|
5.6%
3/54 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
2.0%
1/51 • 24 weeks
|
5.3%
1/19 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
|
General disorders
Fatigue
|
3.7%
2/54 • 24 weeks
|
3.7%
2/54 • 24 weeks
|
5.8%
3/52 • 24 weeks
|
2.0%
1/51 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
5.3%
1/19 • 24 weeks
|
|
General disorders
Oedema Peripheral
|
3.7%
2/54 • 24 weeks
|
5.6%
3/54 • 24 weeks
|
3.8%
2/52 • 24 weeks
|
3.9%
2/51 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
5.3%
1/19 • 24 weeks
|
|
Infections and infestations
Bronchitis
|
1.9%
1/54 • 24 weeks
|
1.9%
1/54 • 24 weeks
|
5.8%
3/52 • 24 weeks
|
2.0%
1/51 • 24 weeks
|
5.3%
1/19 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
|
Infections and infestations
Influenza
|
7.4%
4/54 • 24 weeks
|
1.9%
1/54 • 24 weeks
|
1.9%
1/52 • 24 weeks
|
3.9%
2/51 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
|
Infections and infestations
Nasopharyngitis
|
3.7%
2/54 • 24 weeks
|
11.1%
6/54 • 24 weeks
|
5.8%
3/52 • 24 weeks
|
7.8%
4/51 • 24 weeks
|
5.3%
1/19 • 24 weeks
|
5.3%
1/19 • 24 weeks
|
|
Infections and infestations
Sinusitis
|
3.7%
2/54 • 24 weeks
|
5.6%
3/54 • 24 weeks
|
5.8%
3/52 • 24 weeks
|
5.9%
3/51 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
13.0%
7/54 • 24 weeks
|
20.4%
11/54 • 24 weeks
|
13.5%
7/52 • 24 weeks
|
15.7%
8/51 • 24 weeks
|
10.5%
2/19 • 24 weeks
|
15.8%
3/19 • 24 weeks
|
|
Infections and infestations
Urinary Tract Infection
|
5.6%
3/54 • 24 weeks
|
0.00%
0/54 • 24 weeks
|
3.8%
2/52 • 24 weeks
|
3.9%
2/51 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
10.5%
2/19 • 24 weeks
|
|
Infections and infestations
Viral Infection
|
1.9%
1/54 • 24 weeks
|
0.00%
0/54 • 24 weeks
|
7.7%
4/52 • 24 weeks
|
3.9%
2/51 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.7%
2/54 • 24 weeks
|
3.7%
2/54 • 24 weeks
|
1.9%
1/52 • 24 weeks
|
11.8%
6/51 • 24 weeks
|
5.3%
1/19 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
|
Nervous system disorders
Dizziness
|
3.7%
2/54 • 24 weeks
|
5.6%
3/54 • 24 weeks
|
9.6%
5/52 • 24 weeks
|
5.9%
3/51 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
|
Nervous system disorders
Headache
|
18.5%
10/54 • 24 weeks
|
18.5%
10/54 • 24 weeks
|
28.8%
15/52 • 24 weeks
|
23.5%
12/51 • 24 weeks
|
15.8%
3/19 • 24 weeks
|
21.1%
4/19 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
6/54 • 24 weeks
|
1.9%
1/54 • 24 weeks
|
1.9%
1/52 • 24 weeks
|
0.00%
0/51 • 24 weeks
|
5.3%
1/19 • 24 weeks
|
5.3%
1/19 • 24 weeks
|
|
Cardiac disorders
Palpitations
|
0.00%
0/54 • 24 weeks
|
0.00%
0/54 • 24 weeks
|
1.9%
1/52 • 24 weeks
|
0.00%
0/51 • 24 weeks
|
5.3%
1/19 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
|
Eye disorders
Blepharospasm
|
0.00%
0/54 • 24 weeks
|
0.00%
0/54 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/51 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
5.3%
1/19 • 24 weeks
|
|
Eye disorders
Conjunctivitis
|
1.9%
1/54 • 24 weeks
|
0.00%
0/54 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/51 • 24 weeks
|
5.3%
1/19 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
|
Gastrointestinal disorders
Change Of Bowel Habit
|
0.00%
0/54 • 24 weeks
|
0.00%
0/54 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/51 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
5.3%
1/19 • 24 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
3.7%
2/54 • 24 weeks
|
1.9%
1/54 • 24 weeks
|
1.9%
1/52 • 24 weeks
|
3.9%
2/51 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
5.3%
1/19 • 24 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/54 • 24 weeks
|
1.9%
1/54 • 24 weeks
|
3.8%
2/52 • 24 weeks
|
2.0%
1/51 • 24 weeks
|
5.3%
1/19 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
|
Gastrointestinal disorders
Lip Swelling
|
0.00%
0/54 • 24 weeks
|
0.00%
0/54 • 24 weeks
|
1.9%
1/52 • 24 weeks
|
0.00%
0/51 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
5.3%
1/19 • 24 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/54 • 24 weeks
|
1.9%
1/54 • 24 weeks
|
1.9%
1/52 • 24 weeks
|
0.00%
0/51 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
5.3%
1/19 • 24 weeks
|
|
General disorders
Influenza Like Illness
|
0.00%
0/54 • 24 weeks
|
0.00%
0/54 • 24 weeks
|
1.9%
1/52 • 24 weeks
|
0.00%
0/51 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
5.3%
1/19 • 24 weeks
|
|
Infections and infestations
Cystitis
|
0.00%
0/54 • 24 weeks
|
0.00%
0/54 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/51 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
5.3%
1/19 • 24 weeks
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/54 • 24 weeks
|
0.00%
0/54 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/51 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
5.3%
1/19 • 24 weeks
|
|
Infections and infestations
Oral Herpes
|
0.00%
0/54 • 24 weeks
|
0.00%
0/54 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/51 • 24 weeks
|
5.3%
1/19 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
|
Infections and infestations
Paronychia
|
0.00%
0/54 • 24 weeks
|
0.00%
0/54 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/51 • 24 weeks
|
5.3%
1/19 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
|
Infections and infestations
Pharyngitis
|
1.9%
1/54 • 24 weeks
|
0.00%
0/54 • 24 weeks
|
1.9%
1/52 • 24 weeks
|
0.00%
0/51 • 24 weeks
|
21.1%
4/19 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
|
Injury, poisoning and procedural complications
Tooth Fracture
|
0.00%
0/54 • 24 weeks
|
0.00%
0/54 • 24 weeks
|
1.9%
1/52 • 24 weeks
|
0.00%
0/51 • 24 weeks
|
5.3%
1/19 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
|
Metabolism and nutrition disorders
Fluid Retention
|
0.00%
0/54 • 24 weeks
|
0.00%
0/54 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/51 • 24 weeks
|
5.3%
1/19 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/54 • 24 weeks
|
1.9%
1/54 • 24 weeks
|
1.9%
1/52 • 24 weeks
|
0.00%
0/51 • 24 weeks
|
5.3%
1/19 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.7%
2/54 • 24 weeks
|
1.9%
1/54 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
3.9%
2/51 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
5.3%
1/19 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/54 • 24 weeks
|
0.00%
0/54 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
2.0%
1/51 • 24 weeks
|
5.3%
1/19 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/54 • 24 weeks
|
0.00%
0/54 • 24 weeks
|
1.9%
1/52 • 24 weeks
|
0.00%
0/51 • 24 weeks
|
10.5%
2/19 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/54 • 24 weeks
|
1.9%
1/54 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/51 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
5.3%
1/19 • 24 weeks
|
|
Nervous system disorders
Migraine
|
1.9%
1/54 • 24 weeks
|
3.7%
2/54 • 24 weeks
|
3.8%
2/52 • 24 weeks
|
2.0%
1/51 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
5.3%
1/19 • 24 weeks
|
|
Nervous system disorders
Sinus Headache
|
0.00%
0/54 • 24 weeks
|
3.7%
2/54 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/51 • 24 weeks
|
5.3%
1/19 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/54 • 24 weeks
|
0.00%
0/54 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/51 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
5.3%
1/19 • 24 weeks
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/54 • 24 weeks
|
0.00%
0/54 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/51 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
5.3%
1/19 • 24 weeks
|
|
Reproductive system and breast disorders
Postmenopausal Haemorrhage
|
0.00%
0/54 • 24 weeks
|
0.00%
0/54 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/51 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
5.3%
1/19 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
1.9%
1/54 • 24 weeks
|
0.00%
0/54 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/51 • 24 weeks
|
5.3%
1/19 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/54 • 24 weeks
|
0.00%
0/54 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/51 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
5.3%
1/19 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
0.00%
0/54 • 24 weeks
|
0.00%
0/54 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/51 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
5.3%
1/19 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.00%
0/54 • 24 weeks
|
0.00%
0/54 • 24 weeks
|
3.8%
2/52 • 24 weeks
|
0.00%
0/51 • 24 weeks
|
5.3%
1/19 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
0.00%
0/54 • 24 weeks
|
0.00%
0/54 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/51 • 24 weeks
|
5.3%
1/19 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
|
Vascular disorders
Haematoma
|
0.00%
0/54 • 24 weeks
|
0.00%
0/54 • 24 weeks
|
0.00%
0/52 • 24 weeks
|
0.00%
0/51 • 24 weeks
|
5.3%
1/19 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
|
Vascular disorders
Hot Flush
|
0.00%
0/54 • 24 weeks
|
1.9%
1/54 • 24 weeks
|
1.9%
1/52 • 24 weeks
|
0.00%
0/51 • 24 weeks
|
5.3%
1/19 • 24 weeks
|
0.00%
0/19 • 24 weeks
|
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 guidelines.
- Publication restrictions are in place
Restriction type: OTHER