Trial Outcomes & Findings for MK-0954E Phase III Long-Term Study in Participants With Hypertension (MK-0954E-356) (NCT NCT01299376)
NCT ID: NCT01299376
Last Updated: 2018-08-22
Results Overview
Sitting diastolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration at Week 8. The difference between the baseline and Week 8 assessments was calculated and summarized by treatment arm.
COMPLETED
PHASE3
286 participants
Baseline and Week 8
2018-08-22
Participant Flow
All participants received single-blind losartan 50 mg (L50)/hydrochlorothiazide 12.5 mg (H12.5) and placebo for L50/H12.5/amlodipine 5 mg (A5) during 8-week Filter Period. A total of 510 entered the Filter Period and 286 were randomly assigned to 1 of the 2 treatment arms for the Double-blind Treatment Period.
Participant milestones
| Measure |
L50/H12.5/A5→L50/H12.5/A5
One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open-label extension.
|
L50/H12.5→L50/H12.5/A5
One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension.
|
|---|---|---|
|
Double-blind Treatment (Weeks 1 to 8)
STARTED
|
141
|
145
|
|
Double-blind Treatment (Weeks 1 to 8)
COMPLETED
|
134
|
133
|
|
Double-blind Treatment (Weeks 1 to 8)
NOT COMPLETED
|
7
|
12
|
|
Extension (Weeks 9 to 52)
STARTED
|
134
|
133
|
|
Extension (Weeks 9 to 52)
COMPLETED
|
124
|
118
|
|
Extension (Weeks 9 to 52)
NOT COMPLETED
|
10
|
15
|
Reasons for withdrawal
| Measure |
L50/H12.5/A5→L50/H12.5/A5
One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open-label extension.
|
L50/H12.5→L50/H12.5/A5
One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension.
|
|---|---|---|
|
Double-blind Treatment (Weeks 1 to 8)
Adverse Event
|
1
|
2
|
|
Double-blind Treatment (Weeks 1 to 8)
Lack of Efficacy
|
0
|
1
|
|
Double-blind Treatment (Weeks 1 to 8)
Lost to Follow-up
|
0
|
1
|
|
Double-blind Treatment (Weeks 1 to 8)
Blood Pressure/Potassium Criteria Met
|
4
|
7
|
|
Double-blind Treatment (Weeks 1 to 8)
Protocol Violation
|
1
|
0
|
|
Double-blind Treatment (Weeks 1 to 8)
Withdrawal by Subject
|
1
|
1
|
|
Extension (Weeks 9 to 52)
Withdrawal by Subject
|
2
|
1
|
|
Extension (Weeks 9 to 52)
Adverse Event
|
2
|
3
|
|
Extension (Weeks 9 to 52)
Lost to Follow-up
|
1
|
2
|
|
Extension (Weeks 9 to 52)
Blood Pressure/Potassium Criteria Met
|
4
|
9
|
|
Extension (Weeks 9 to 52)
Physician Decision
|
1
|
0
|
Baseline Characteristics
MK-0954E Phase III Long-Term Study in Participants With Hypertension (MK-0954E-356)
Baseline characteristics by cohort
| Measure |
L50/H12.5/A5→L50/H12.5/A5
n=141 Participants
One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open-label extension.
|
L50/H12.5→L50/H12.5/A5
n=145 Participants
One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension.
|
Total
n=286 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.9 Years
STANDARD_DEVIATION 9.1 • n=99 Participants
|
56.3 Years
STANDARD_DEVIATION 9.7 • n=107 Participants
|
55.1 Years
STANDARD_DEVIATION 9.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
108 Participants
n=99 Participants
|
111 Participants
n=107 Participants
|
219 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 8Population: All participants that received at least one dose of study treatment during double-blind treatment period , had at least 1 post-randomization observation for the analysis endpoint, and had baseline data
Sitting diastolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration at Week 8. The difference between the baseline and Week 8 assessments was calculated and summarized by treatment arm.
Outcome measures
| Measure |
L50/H12.5/A5
n=141 Participants
One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
|
L50/H12.5
n=144 Participants
One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
|
|---|---|---|
|
Change in Trough Sitting Diastolic Blood Pressure (SiDBP)-Double-Blind Treatment Period
|
-12.1 mmHg
Interval -13.3 to -10.9
|
-6.2 mmHg
Interval -7.4 to -5.0
|
PRIMARY outcome
Timeframe: up to Week 8Population: All randomized participants who received at least 1 dose of study drug during double-blind treatment period.
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who experienced at least 1 AE during the 8-week double-blind treatment period were summarized by study drug received.
Outcome measures
| Measure |
L50/H12.5/A5
n=141 Participants
One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
|
L50/H12.5
n=145 Participants
One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
|
|---|---|---|
|
Percentage of Participants Who Experience 1 or More Adverse Events (AEs)- Double-Blind Treatment Period
|
27.0 Percentage of Participants
|
29.7 Percentage of Participants
|
PRIMARY outcome
Timeframe: up to Week 8Population: All randomized participants who received at least 1 dose of study drug during double-blind treatment period.
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Percentage of participants that experienced at least 1 AE that was reported as possibly, probably, or definitely related to the study drug by the investigator during the 8-week double-blind treatment period were summarized by study drug received.
Outcome measures
| Measure |
L50/H12.5/A5
n=141 Participants
One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
|
L50/H12.5
n=145 Participants
One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
|
|---|---|---|
|
Percentage of Participants Who Experience 1 or More Drug-Related AEs- Double-Blind Treatment Period
|
12.1 Percentage of Participants
|
14.5 Percentage of Participants
|
PRIMARY outcome
Timeframe: up to Week 8Population: All randomized participants who received at least 1 dose of study drug during double-blind treatment period.
An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. The percentage of participants who experienced at least 1 SAE during the 8-week double-blind treatment period were summarized by study drug received.
Outcome measures
| Measure |
L50/H12.5/A5
n=141 Participants
One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
|
L50/H12.5
n=145 Participants
One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
|
|---|---|---|
|
Percentage of Participants Who Experience 1 or Serious Adverse Events (SAEs)- Double-Blind Treatment Period
|
0.7 Percentage of Participants
|
1.4 Percentage of Participants
|
PRIMARY outcome
Timeframe: up to Week 8Population: All randomized participants who received at least 1 dose of study drug during double-blind treatment period.
An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. Percentage of participants that experienced at least 1 SAE that was reported as possibly, probably, or definitely related to the study drug by the investigator during the 8-week double-blind treatment period were summarized by study drug received.
Outcome measures
| Measure |
L50/H12.5/A5
n=141 Participants
One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
|
L50/H12.5
n=145 Participants
One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
|
|---|---|---|
|
Percentage of Participants Who Experience 1 or More Drug-Related Serious Adverse Events (SAEs)- Double-Blind Treatment Period
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: up to Week 8Population: All randomized participants who received at least 1 dose of study drug during double-blind treatment period.
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who had study drug stopped during the 8-week double-blind treatment period due to an AE regardless of whether or not they completed the study was summarized by treatment arm.
Outcome measures
| Measure |
L50/H12.5/A5
n=141 Participants
One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
|
L50/H12.5
n=145 Participants
One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
|
|---|---|---|
|
Percentage of Participants Who Had Study Drug Discontinued Due to an AE - Double Blind Treatment Period
|
0.7 Percentage of Participants
|
1.4 Percentage of Participants
|
PRIMARY outcome
Timeframe: Week 9 up to Week 52 for L50/H12.5→L50/H12.5/A5 arm; Week 1 to Week 52 for L50/H12.5/A5→L50/H12.5/A5Population: All randomized participants who received at least 1 dose of study drug during long-term reporting period.
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants that experienced at least 1 AE during long-term period was summarized.
Outcome measures
| Measure |
L50/H12.5/A5
n=141 Participants
One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
|
L50/H12.5
n=133 Participants
One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
|
|---|---|---|
|
Percentage of Participants Who Experience 1 or More Adverse Events (AEs)- Long Term
|
70.9 Percentage of Participants
|
66.2 Percentage of Participants
|
PRIMARY outcome
Timeframe: Week 9 up to Week 52 for L50/H12.5→L50/H12.5/A5 arm; Week 1 to Week 52 for L50/H12.5/A5→L50/H12.5/A5Population: All randomized participants who received at least 1 dose of study drug during long-term reporting period.
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Percentage of participants that experienced at least 1 AE that was reported as possibly, probably, or definitely related to the study drug by the investigator during the long-term reporting period was summarized.
Outcome measures
| Measure |
L50/H12.5/A5
n=141 Participants
One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
|
L50/H12.5
n=133 Participants
One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
|
|---|---|---|
|
Percentage of Participants Who Experience 1 or More Drug-related AEs- Long Term
|
27.7 Percentage of Participants
|
14.3 Percentage of Participants
|
PRIMARY outcome
Timeframe: Week 9 up to Week 52 for L50/H12.5→L50/H12.5/A5 arm; Week 1 to Week 52 for L50/H12.5/A5→L50/H12.5/A5Population: All randomized participants who received at least 1 dose of study drug during long-term reporting period.
An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. Those SAEs assessed as possibly, probably, or definitely related to the study drug during the long-term period were summarized.
Outcome measures
| Measure |
L50/H12.5/A5
n=141 Participants
One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
|
L50/H12.5
n=133 Participants
One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
|
|---|---|---|
|
Percentage of Participants Who Experience 1 or More SAEs- Long Term
|
2.1 Percentage of Participants
|
3.0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Week 9 up to Week 52 for L50/H12.5→L50/H12.5/A5 arm; Week 1 to Week 52 for L50/H12.5/A5→L50/H12.5/A5Population: All randomized participants who received at least 1 dose of study drug during long-term reporting period.
An SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. the percentage of participants that experienced an SAE that assessed as possibly, probably, or definitely related to the study drug by the investigator was summarized.
Outcome measures
| Measure |
L50/H12.5/A5
n=141 Participants
One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
|
L50/H12.5
n=133 Participants
One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
|
|---|---|---|
|
Percentage of Participants Who Experience 1 or More Drug-related SAEs- Long Term
|
0.0 Percentage of Participants
|
0.8 Percentage of Participants
|
PRIMARY outcome
Timeframe: Week 9 up to Week 52 for L50/H12.5→L50/H12.5/A5 arm; Week 1 to Week 52 for L50/H12.5/A5→L50/H12.5/A5Population: All randomized participants who received at least 1 dose of study drug during extension period.
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who had study drug discontinued during the 44 week extension due to an AE regardless of completion status were summarized.
Outcome measures
| Measure |
L50/H12.5/A5
n=141 Participants
One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
|
L50/H12.5
n=133 Participants
One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
|
|---|---|---|
|
Percentage of Participants Who Had Study Drug Discontinued From the Study Due to an AE- Long Term
|
2.1 Percentage of Participants
|
2.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: All participants that received at least one dose of study treatment during double-blind treatment period , had at least 1 post-randomization observation for the analysis endpoint, and had baseline data
Sitting systolic blood pressure was measured by automated sphygmomanometer pre-dose on Day 1 (baseline) and at 24 ± 2 hours after the last study drug administration at Week 8.
Outcome measures
| Measure |
L50/H12.5/A5
n=141 Participants
One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
|
L50/H12.5
n=144 Participants
One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
|
|---|---|---|
|
Change in Trough Sitting Systolic Blood Pressure (SiSBP)-Double-Blind Treatment Period
|
-17.7 mmHg
Interval -19.6 to -15.9
|
-7.5 mmHg
Interval -9.3 to -5.7
|
Adverse Events
L50/H12.5- Double Blind Treatment Period
L50/H12.5/A5 - Double Blind Treatment Period
L50/H12.5/A5→L50/H12.5/A5 - Extension
L50/H12.5→L50/H12.5/A5 - Extension
Serious adverse events
| Measure |
L50/H12.5- Double Blind Treatment Period
n=145 participants at risk
Participants received L50/H12.5 combination tablet, orally once daily for 8 weeks
|
L50/H12.5/A5 - Double Blind Treatment Period
n=141 participants at risk
Participants received L50/H12.5/A5 combination tablet, orally once daily for 8 weeks
|
L50/H12.5/A5→L50/H12.5/A5 - Extension
n=134 participants at risk
Participants who received L50/H12.5/A5 combination tablet in double-blind treatment period and continued to receive L50/H12.5/A5 orally once daily for 44 weeks in extension period.
|
L50/H12.5→L50/H12.5/A5 - Extension
n=133 participants at risk
Participants who received L50/H12.5 combination tablet in double-blind treatment period and then received L50/H12.5/A5 orally once daily for 44 weeks in extension period.
|
|---|---|---|---|---|
|
Eye disorders
Cataract
|
0.00%
0/145 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
0.71%
1/141 • Number of events 1 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
0.00%
0/134 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
0.00%
0/133 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.69%
1/145 • Number of events 1 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
0.00%
0/141 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
0.75%
1/134 • Number of events 1 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
0.00%
0/133 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.69%
1/145 • Number of events 1 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
0.00%
0/141 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
0.00%
0/134 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
0.00%
0/133 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
|
Gastrointestinal disorders
Enterocele
|
0.00%
0/145 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
0.00%
0/141 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
0.00%
0/134 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
0.75%
1/133 • Number of events 1 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the duodenum
|
0.00%
0/145 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
0.00%
0/141 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
0.75%
1/134 • Number of events 1 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
0.00%
0/133 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liposarcoma
|
0.00%
0/145 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
0.00%
0/141 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
0.00%
0/134 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
0.75%
1/133 • Number of events 1 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of renal pelvis
|
0.00%
0/145 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
0.00%
0/141 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
0.00%
0/134 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
0.75%
1/133 • Number of events 1 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/145 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
0.00%
0/141 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
0.00%
0/134 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
0.75%
1/133 • Number of events 1 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
Other adverse events
| Measure |
L50/H12.5- Double Blind Treatment Period
n=145 participants at risk
Participants received L50/H12.5 combination tablet, orally once daily for 8 weeks
|
L50/H12.5/A5 - Double Blind Treatment Period
n=141 participants at risk
Participants received L50/H12.5/A5 combination tablet, orally once daily for 8 weeks
|
L50/H12.5/A5→L50/H12.5/A5 - Extension
n=134 participants at risk
Participants who received L50/H12.5/A5 combination tablet in double-blind treatment period and continued to receive L50/H12.5/A5 orally once daily for 44 weeks in extension period.
|
L50/H12.5→L50/H12.5/A5 - Extension
n=133 participants at risk
Participants who received L50/H12.5 combination tablet in double-blind treatment period and then received L50/H12.5/A5 orally once daily for 44 weeks in extension period.
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
6.2%
9/145 • Number of events 9 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
2.1%
3/141 • Number of events 3 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
22.4%
30/134 • Number of events 35 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
22.6%
30/133 • Number of events 44 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
|
Investigations
Blood uric acid increased
|
6.9%
10/145 • Number of events 10 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
5.0%
7/141 • Number of events 7 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
3.0%
4/134 • Number of events 5 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
5.3%
7/133 • Number of events 7 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/145 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
2.1%
3/141 • Number of events 3 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
5.2%
7/134 • Number of events 7 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
5.3%
7/133 • Number of events 7 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.69%
1/145 • Number of events 1 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
0.71%
1/141 • Number of events 1 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
3.0%
4/134 • Number of events 4 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
5.3%
7/133 • Number of events 7 • Double blind treatment period - Week 1 up to Week 8; Extension - Week 9 up to Week 52
All randomized participants who received at least 1 dose of study drug during the reporting period.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck, Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER