Trial Outcomes & Findings for Dose-ranging Study to Evaluate the Effectiveness and Tolerability of MK0736 in Patients With Type 2 Diabetes Mellitus (T2DM) and Hypertension (0736-007) (NCT NCT00806585)
NCT ID: NCT00806585
Last Updated: 2015-09-21
Results Overview
Participant remained in the sitting position for at least 5 minutes before any blood pressure readings were recorded. Systolic and diastolic blood pressures were determined by taking 6 replicate measurements obtained 1 to 2 minutes apart. First reading was discarded and the average of the last 5 measurement was recorded.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
620 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2015-09-21
Participant Flow
Study terminated after participants completed a minimum of 24 weeks of the study (i.e., Phase A) due to lack of efficacy. Phase B was not conducted.
Participant milestones
| Measure |
MK-0736 0.5 mg
One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
|
MK-0736 2.0 mg
One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
|
MK-0736 8.0 mg
One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
|
HCTZ 12.5 mg → MK-0736 8.0 mg
one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
|
Placebo
One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
137
|
134
|
141
|
71
|
137
|
|
Overall Study
COMPLETED
|
105
|
103
|
109
|
56
|
106
|
|
Overall Study
NOT COMPLETED
|
32
|
31
|
32
|
15
|
31
|
Reasons for withdrawal
| Measure |
MK-0736 0.5 mg
One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
|
MK-0736 2.0 mg
One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
|
MK-0736 8.0 mg
One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
|
HCTZ 12.5 mg → MK-0736 8.0 mg
one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
|
Placebo
One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
|
|---|---|---|---|---|---|
|
Overall Study
Study terminated by Sponsor
|
0
|
0
|
1
|
2
|
0
|
|
Overall Study
Protocol Violation
|
3
|
1
|
2
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
2
|
3
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
2
|
2
|
5
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
1
|
5
|
3
|
4
|
2
|
|
Overall Study
Withdrawal by Subject
|
10
|
8
|
9
|
3
|
11
|
|
Overall Study
Completion status unknown
|
15
|
14
|
12
|
4
|
12
|
Baseline Characteristics
Dose-ranging Study to Evaluate the Effectiveness and Tolerability of MK0736 in Patients With Type 2 Diabetes Mellitus (T2DM) and Hypertension (0736-007)
Baseline characteristics by cohort
| Measure |
MK-0736 0.5 mg
n=137 Participants
One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
|
MK-0736 2.0 mg
n=134 Participants
One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
|
MK-0736 8.0 mg
n=141 Participants
One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
|
HCTZ 12.5 mg → MK-0736 8.0 mg
n=71 Participants
one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
|
Placebo
n=137 Participants
One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
|
Total
n=620 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
58.0 years
n=5 Participants
|
60.0 years
n=7 Participants
|
58.0 years
n=5 Participants
|
57.0 years
n=4 Participants
|
58.0 years
n=21 Participants
|
58.0 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
250 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
89 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
87 Participants
n=21 Participants
|
370 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis Set (FAS) Population defined as all participants who received at least 1 dose of study drug and had endpoint data (both baseline and post-randomization)
Participant remained in the sitting position for at least 5 minutes before any blood pressure readings were recorded. Systolic and diastolic blood pressures were determined by taking 6 replicate measurements obtained 1 to 2 minutes apart. First reading was discarded and the average of the last 5 measurement was recorded.
Outcome measures
| Measure |
MK-0736 0.5 mg
n=135 Participants
One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
|
MK-0736 2.0 mg
n=132 Participants
One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
|
MK-0736 8.0 mg
n=140 Participants
One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
|
HCTZ 12.5 mg → MK-0736 8.0 mg
n=70 Participants
one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
|
Placebo
n=136 Participants
One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
|
|---|---|---|---|---|---|
|
Change From Baseline in Sitting Diastolic Blood Pressure (SiDBP) at Week 12
|
-5.8 mmHg
Standard Error 0.7
|
-5.7 mmHg
Standard Error 0.7
|
-6.7 mmHg
Standard Error 0.7
|
-7.7 mmHg
Standard Error 1.0
|
-5.6 mmHg
Standard Error 0.7
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis Set (FAS) Population defined as all participants who received at least 1 dose of study drug and had endpoint data (both baseline and post-randomization)
Participant remained in the sitting position for at least 5 minutes before any blood pressure readings were recorded. Systolic and diastolic blood pressures were determined by taking 6 replicate measurements obtained 1 to 2 minutes apart. First reading was discarded and the average the last 5 measurement was recorded.
Outcome measures
| Measure |
MK-0736 0.5 mg
n=135 Participants
One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
|
MK-0736 2.0 mg
n=132 Participants
One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
|
MK-0736 8.0 mg
n=140 Participants
One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
|
HCTZ 12.5 mg → MK-0736 8.0 mg
n=70 Participants
one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
|
Placebo
n=136 Participants
One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
|
|---|---|---|---|---|---|
|
Change From Baseline in Sitting Systolic Blood Pressure (SiSBP) at Week 12
|
-5.7 mmHg
Standard Error 1.1
|
-7.2 mmHg
Standard Error 1.1
|
-6.3 mmHg
Standard Error 1.1
|
-12.4 mmHg
Standard Error 1.5
|
-5.4 mmHg
Standard Error 1.2
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: Full Analysis Set (FAS) Population defined as all participants who received at least 1 dose of study drug and had endpoint data (both baseline and post-randomization)
LDL-C calculated by the method of Friedewald equation at baseline and after 12 weeks of study drug administration
Outcome measures
| Measure |
MK-0736 0.5 mg
n=135 Participants
One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
|
MK-0736 2.0 mg
n=132 Participants
One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
|
MK-0736 8.0 mg
n=138 Participants
One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
|
HCTZ 12.5 mg → MK-0736 8.0 mg
n=70 Participants
one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
|
Placebo
n=136 Participants
One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
|
1.1 Percentage Change
Standard Error 2.3
|
3.9 Percentage Change
Standard Error 2.5
|
0.6 Percentage Change
Standard Error 2.5
|
2.8 Percentage Change
Standard Error 3.5
|
2.0 Percentage Change
Standard Error 2.5
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Full Analysis Set (FAS) Population defined as all participants who received at least 1 dose of study drug and had endpoint data (both baseline and post-randomization)
Fasting weight was assessed at baseline and after 24 weeks of study drug administration and was measured after voiding, with shoes and socks off, wearing clinic gown to reduce variability and maintain consistency. Same standardized digital scale was used throughout the study.
Outcome measures
| Measure |
MK-0736 0.5 mg
n=135 Participants
One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
|
MK-0736 2.0 mg
n=132 Participants
One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
|
MK-0736 8.0 mg
n=140 Participants
One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
|
HCTZ 12.5 mg → MK-0736 8.0 mg
n=70 Participants
one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
|
Placebo
n=136 Participants
One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
|
|---|---|---|---|---|---|
|
Change From Baseline in Body Weight at Week 24
|
-0.7 kg
Standard Error 0.5
|
-1.4 kg
Standard Error 0.5
|
-1.3 kg
Standard Error 0.5
|
-1.6 kg
Standard Error 0.7
|
0.6 kg
Standard Error 0.5
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Full Analysis Set (FAS) Population defined as all participants who received at least 1 dose of study drug and did not lack of any endpoint data (both baseline and post-randomization)
HbA1c reported as a % and was measured at baseline and after 24 weeks of study drug administration
Outcome measures
| Measure |
MK-0736 0.5 mg
n=135 Participants
One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
|
MK-0736 2.0 mg
n=132 Participants
One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
|
MK-0736 8.0 mg
n=140 Participants
One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
|
HCTZ 12.5 mg → MK-0736 8.0 mg
n=70 Participants
one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
|
Placebo
n=136 Participants
One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
|
|---|---|---|---|---|---|
|
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24
|
-0.10 Percentage Change
Standard Error 0.09
|
-0.16 Percentage Change
Standard Error 0.10
|
-0.06 Percentage Change
Standard Error 0.09
|
-0.20 Percentage Change
Standard Error 0.13
|
0.13 Percentage Change
Standard Error 0.10
|
Adverse Events
MK-0736 0.5 mg
Serious events: 9 serious events
Other events: 46 other events
Deaths: 0 deaths
MK-0736 2.0 mg
Serious events: 7 serious events
Other events: 54 other events
Deaths: 0 deaths
MK-0736 8.0 mg
Serious events: 6 serious events
Other events: 54 other events
Deaths: 0 deaths
HCTZ 12.5 mg → MK-0736 8.0 mg
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Placebo
Serious events: 5 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MK-0736 0.5 mg
n=137 participants at risk
One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
|
MK-0736 2.0 mg
n=134 participants at risk
One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
|
MK-0736 8.0 mg
n=141 participants at risk
One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
|
HCTZ 12.5 mg → MK-0736 8.0 mg
n=71 participants at risk
one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
|
Placebo
n=137 participants at risk
One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
|
|---|---|---|---|---|---|
|
Cardiac disorders
Angina unstable
|
0.00%
0/137 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.75%
1/134 • Number of events 1 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/141 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/71 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.73%
1/137 • Number of events 1 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.73%
1/137 • Number of events 1 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/134 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/141 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/71 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/137 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/137 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.75%
1/134 • Number of events 1 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/141 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/71 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/137 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
|
Cardiac disorders
Coronary artery disease
|
0.73%
1/137 • Number of events 1 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.75%
1/134 • Number of events 1 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/141 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/71 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/137 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
|
Cardiac disorders
Myocardial infarction
|
0.73%
1/137 • Number of events 1 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.75%
1/134 • Number of events 1 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/141 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/71 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/137 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/137 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.75%
1/134 • Number of events 1 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/141 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/71 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/137 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
|
General disorders
Chest discomfort
|
0.00%
0/137 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/134 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/141 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/71 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.73%
1/137 • Number of events 1 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
|
General disorders
Oedema peripheral
|
0.00%
0/137 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.75%
1/134 • Number of events 1 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.71%
1/141 • Number of events 1 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/71 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/137 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/137 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/134 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/141 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/71 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.73%
1/137 • Number of events 1 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
|
Infections and infestations
Eczema infected
|
0.00%
0/137 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/134 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.71%
1/141 • Number of events 1 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/71 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/137 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.73%
1/137 • Number of events 1 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/134 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/141 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/71 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/137 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/137 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/134 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/141 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/71 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.73%
1/137 • Number of events 1 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/137 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/134 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/141 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/71 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.73%
1/137 • Number of events 1 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/137 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/134 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.71%
1/141 • Number of events 1 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/71 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/137 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.73%
1/137 • Number of events 1 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/134 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/141 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/71 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/137 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.00%
0/137 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.75%
1/134 • Number of events 1 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/141 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/71 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/137 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/137 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/134 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.71%
1/141 • Number of events 1 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/71 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/137 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.73%
1/137 • Number of events 1 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/134 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/141 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/71 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/137 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/137 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/134 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.71%
1/141 • Number of events 1 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/71 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/137 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
|
Nervous system disorders
Convulsion
|
0.73%
1/137 • Number of events 1 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/134 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/141 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/71 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/137 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
|
Nervous system disorders
Paresis cranial nerve
|
0.73%
1/137 • Number of events 1 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/134 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/141 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/71 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/137 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/137 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/134 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.71%
1/141 • Number of events 1 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/71 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/137 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/137 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/134 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.71%
1/141 • Number of events 1 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/71 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/137 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
|
Renal and urinary disorders
Renal colic
|
0.73%
1/137 • Number of events 1 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/134 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/141 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/71 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/137 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/137 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/134 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.71%
1/141 • Number of events 1 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/71 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/137 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/137 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/134 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.71%
1/141 • Number of events 1 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/71 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/137 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.73%
1/137 • Number of events 1 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/134 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/141 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/71 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
0.00%
0/137 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
Other adverse events
| Measure |
MK-0736 0.5 mg
n=137 participants at risk
One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
|
MK-0736 2.0 mg
n=134 participants at risk
One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
|
MK-0736 8.0 mg
n=141 participants at risk
One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
|
HCTZ 12.5 mg → MK-0736 8.0 mg
n=71 participants at risk
one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
|
Placebo
n=137 participants at risk
One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
|
|---|---|---|---|---|---|
|
General disorders
Oedema peripheral
|
0.73%
1/137 • Number of events 1 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
1.5%
2/134 • Number of events 2 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
5.7%
8/141 • Number of events 10 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
2.8%
2/71 • Number of events 2 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
1.5%
2/137 • Number of events 2 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
|
Infections and infestations
Nasopharyngitis
|
1.5%
2/137 • Number of events 2 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
6.0%
8/134 • Number of events 9 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
2.1%
3/141 • Number of events 4 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
2.8%
2/71 • Number of events 2 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
3.6%
5/137 • Number of events 5 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.8%
8/137 • Number of events 12 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
7.5%
10/134 • Number of events 17 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
5.0%
7/141 • Number of events 7 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
5.6%
4/71 • Number of events 5 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
5.1%
7/137 • Number of events 9 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
|
Investigations
Low density lipoprotein increased
|
6.6%
9/137 • Number of events 10 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
7.5%
10/134 • Number of events 10 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
6.4%
9/141 • Number of events 9 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
7.0%
5/71 • Number of events 5 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
2.9%
4/137 • Number of events 4 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
17.5%
24/137 • Number of events 118 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
17.9%
24/134 • Number of events 79 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
19.9%
28/141 • Number of events 91 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
12.7%
9/71 • Number of events 91 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
19.7%
27/137 • Number of events 197 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
|
Nervous system disorders
Headache
|
2.9%
4/137 • Number of events 5 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
6.0%
8/134 • Number of events 12 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
7.1%
10/141 • Number of events 13 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
5.6%
4/71 • Number of events 8 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
5.8%
8/137 • Number of events 8 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
|
Vascular disorders
Hypertension
|
2.9%
4/137 • Number of events 5 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
3.0%
4/134 • Number of events 4 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
6.4%
9/141 • Number of events 9 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
1.4%
1/71 • Number of events 1 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
3.6%
5/137 • Number of events 6 • 76 weeks
All Randomized Participants. Adverse events were reported for Phase A only (24 weeks). Phase B (52 weeks) was not completed.
|
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