Trial Outcomes & Findings for BP-EASE -Effectiveness of Losartan 50 mg/Hydrochlorothiazide (HCTZ) 12.5 mg Versus Valsartan 80 mg/HCTZ 12.5 mg Titrated as Needed in Patients With Essential Hypertension Not Controlled on Monotherapy (0954A-333) (NCT NCT00546754)
NCT ID: NCT00546754
Last Updated: 2024-05-16
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
808 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2024-05-16
Participant Flow
First patient in: MAY-04-2007 Last patient out: APRIL-16-2009 Total number of sites: 163 sites in Canada
Participant milestones
| Measure |
Losartan 50 mg/HCTZ 12.5 mg
Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
|
Valsartan 80 mg/HCTZ 12.5 mg
Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
|
|---|---|---|
|
Overall Study
STARTED
|
425
|
383
|
|
Overall Study
Treated
|
416
|
373
|
|
Overall Study
Week 6
|
396
|
347
|
|
Overall Study
Week 12
|
375
|
334
|
|
Overall Study
COMPLETED
|
375
|
334
|
|
Overall Study
NOT COMPLETED
|
50
|
49
|
Reasons for withdrawal
| Measure |
Losartan 50 mg/HCTZ 12.5 mg
Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
|
Valsartan 80 mg/HCTZ 12.5 mg
Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
|
|---|---|---|
|
Overall Study
Serious Adverse Event
|
1
|
1
|
|
Overall Study
Adverse Event
|
11
|
16
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
9
|
15
|
|
Overall Study
Protocol Violation
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
6
|
7
|
|
Overall Study
Dyspnea
|
1
|
0
|
|
Overall Study
Per Data Query, Less Than 4 Wks Coversyl
|
1
|
0
|
|
Overall Study
Hip Replacement
|
1
|
0
|
|
Overall Study
Suicide
|
1
|
0
|
|
Overall Study
Missing Cooperation
|
1
|
0
|
|
Overall Study
Elevated Creatinine and Potassium levels
|
0
|
1
|
|
Overall Study
Patient's Decision
|
0
|
1
|
|
Overall Study
Missing
|
14
|
7
|
Baseline Characteristics
BP-EASE -Effectiveness of Losartan 50 mg/Hydrochlorothiazide (HCTZ) 12.5 mg Versus Valsartan 80 mg/HCTZ 12.5 mg Titrated as Needed in Patients With Essential Hypertension Not Controlled on Monotherapy (0954A-333)
Baseline characteristics by cohort
| Measure |
Losartan 50 mg/HCTZ 12.5 mg
n=416 Participants
Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
416 number of patients that received at least one dose of study medication and had 1 follow-up visit (intent-to-treat population \[ITT\])
|
Valsartan 80 mg/HCTZ 12.5 mg
n=373 Participants
Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
373 - number of patients that received at least one dose of study medication and had 1 follow-up visit (intent-to-treat population \[ITT\])
|
Total
n=789 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.7 years
STANDARD_DEVIATION 11.11 • n=5 Participants
|
58.3 years
STANDARD_DEVIATION 10.26 • n=7 Participants
|
58.5 years
STANDARD_DEVIATION 10.71 • n=5 Participants
|
|
Sex: Female, Male
Female
|
197 Participants
n=5 Participants
|
180 Participants
n=7 Participants
|
377 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
219 Participants
n=5 Participants
|
193 Participants
n=7 Participants
|
412 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
364 participants
n=5 Participants
|
326 participants
n=7 Participants
|
690 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
8 participants
n=5 Participants
|
13 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
34 participants
n=5 Participants
|
29 participants
n=7 Participants
|
63 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
East Indian
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
From Middle East
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: 416 and 373 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 371 and 331 patients at week 12 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively
Outcome measures
| Measure |
Losartan 50 mg/HCTZ 12.5 mg
n=371 Participants
Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
|
Valsartan 80 mg/HCTZ 12.5 mg
n=331 Participants
Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
|
|---|---|---|
|
Change in Systolic Blood Pressure From Baseline to Week 12
|
-19.9 mm Hg
Standard Deviation 13.79
|
-20.8 mm Hg
Standard Deviation 13.61
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: 416 and 373 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 371 and 331 patients at week 12 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively
Outcome measures
| Measure |
Losartan 50 mg/HCTZ 12.5 mg
n=371 Participants
Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
|
Valsartan 80 mg/HCTZ 12.5 mg
n=331 Participants
Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
|
|---|---|---|
|
Change in Diastolic Blood Pressure From Baseline to Week 12
|
-10.6 mm Hg
Standard Deviation 9.28
|
-10.5 mm Hg
Standard Deviation 9.58
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: 416 and 373 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 392 and 344 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively
Outcome measures
| Measure |
Losartan 50 mg/HCTZ 12.5 mg
n=392 Participants
Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
|
Valsartan 80 mg/HCTZ 12.5 mg
n=344 Participants
Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
|
|---|---|---|
|
Change in Systolic Blood Pressure From Baseline to Week 6
|
-16.7 mm Hg
Standard Deviation 14.70
|
-18.2 mm Hg
Standard Deviation 13.84
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: 416 and 373 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 392 and 344 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively
Outcome measures
| Measure |
Losartan 50 mg/HCTZ 12.5 mg
n=392 Participants
Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
|
Valsartan 80 mg/HCTZ 12.5 mg
n=344 Participants
Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
|
|---|---|---|
|
Change in Diastolic Blood Pressure From Baseline to Week 6
|
-8.4 mm Hg
Standard Deviation 9.35
|
-9.1 mm Hg
Standard Deviation 9.16
|
SECONDARY outcome
Timeframe: Week 6Population: 416 and 373 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 393 and 345 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively
Number of Patients Achieving Target Blood Pressure (\<140/90 mm Hg and \<130/80 mm Hg for diabetics) at week 6
Outcome measures
| Measure |
Losartan 50 mg/HCTZ 12.5 mg
n=393 Participants
Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
|
Valsartan 80 mg/HCTZ 12.5 mg
n=345 Participants
Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
|
|---|---|---|
|
Number of Patients Achieving Target Blood Pressure at Week 6
Achieved Target Blood Pressure
|
253 Patients
|
241 Patients
|
|
Number of Patients Achieving Target Blood Pressure at Week 6
Did Not Achieve Target Blood Pressure
|
140 Patients
|
104 Patients
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: 416 and 373 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 372 and 332 patients at week 12 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively
Number of Patients Achieving Target Blood Pressure (\<140/90 mm Hg and \<130/80 mm Hg for diabetics) at week 12
Outcome measures
| Measure |
Losartan 50 mg/HCTZ 12.5 mg
n=372 Participants
Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
|
Valsartan 80 mg/HCTZ 12.5 mg
n=332 Participants
Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
|
|---|---|---|
|
Number of Patients Achieving Target Blood Pressure at Week 12
Achieved Target Blood Pressure
|
278 Patients
|
253 Patients
|
|
Number of Patients Achieving Target Blood Pressure at Week 12
Did Not Achieve Target Blood Pressure
|
94 Patients
|
79 Patients
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 416 and 373 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 406 and 360 patients for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively
Time to achieve the target blood pressure (\<140/90 mmHg and \<130/80 mmHg for diabetics)
Outcome measures
| Measure |
Losartan 50 mg/HCTZ 12.5 mg
n=406 Participants
Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
|
Valsartan 80 mg/HCTZ 12.5 mg
n=360 Participants
Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
|
|---|---|---|
|
Time to Achieve Target Blood Pressure
|
62.3 Days
Standard Deviation 1.44
|
57.3 Days
Standard Deviation 1.24
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: 416 and 373 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 298 and 269 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively
Outcome measures
| Measure |
Losartan 50 mg/HCTZ 12.5 mg
n=298 Participants
Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
|
Valsartan 80 mg/HCTZ 12.5 mg
n=269 Participants
Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
|
|---|---|---|
|
Change in Uric Acid From Baseline to Week 6
|
0.3 umol/L
Standard Deviation 53.12
|
21.7 umol/L
Standard Deviation 55.09
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: 416 and 373 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 286 and 253 patients at week 12 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively
Outcome measures
| Measure |
Losartan 50 mg/HCTZ 12.5 mg
n=286 Participants
Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
|
Valsartan 80 mg/HCTZ 12.5 mg
n=253 Participants
Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
|
|---|---|---|
|
Change in Uric Acid From Baseline to Week 12
|
-0.4 umol/L
Standard Deviation 57.02
|
29.9 umol/L
Standard Deviation 64.79
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: 416 and 373 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 304 and 272 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively
Outcome measures
| Measure |
Losartan 50 mg/HCTZ 12.5 mg
n=304 Participants
Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
|
Valsartan 80 mg/HCTZ 12.5 mg
n=272 Participants
Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
|
|---|---|---|
|
Change in Serum Highly Sensitive C-reactive Protein From Baseline to Week 6
|
0.8 mg/L
Standard Deviation 26.21
|
0.6 mg/L
Standard Deviation 6.60
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: 416 and 373 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 279 and 255 patients at week 12 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively
Outcome measures
| Measure |
Losartan 50 mg/HCTZ 12.5 mg
n=279 Participants
Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
|
Valsartan 80 mg/HCTZ 12.5 mg
n=255 Participants
Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
|
|---|---|---|
|
Change in Serum Highly Sensitive C-reactive Protein From Baseline to Week 12
|
-0.3 umol/L
Standard Deviation 8.05
|
0.5 umol/L
Standard Deviation 7.20
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: 416 and 373 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 300 and 273 patients at week 6 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively
Outcome measures
| Measure |
Losartan 50 mg/HCTZ 12.5 mg
n=300 Participants
Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
|
Valsartan 80 mg/HCTZ 12.5 mg
n=273 Participants
Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
|
|---|---|---|
|
Change in Gamma-Glutamyl Transpeptidase (Gamma-GT) From Baseline to Week 6
|
-1.8 IU/L
Standard Deviation 21.20
|
-0.1 IU/L
Standard Deviation 24.71
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: 416 and 373 - number of patients that received at least one dose of study medication and had 1 follow-up visit (ITT population). Information available for 279 and 254 patients at week 12 for Losartan 50/HCTZ 12.5mg and Valsartan 80/HCTZ 12.5mg respectively
Outcome measures
| Measure |
Losartan 50 mg/HCTZ 12.5 mg
n=279 Participants
Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
|
Valsartan 80 mg/HCTZ 12.5 mg
n=254 Participants
Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
|
|---|---|---|
|
Change in Gamma-Glutamyl Transpeptidase (Gamma-GT) From Baseline to Week 12
|
-0.7 IU/L
Standard Deviation 21.44
|
-0.0 IU/L
Standard Deviation 24.45
|
Adverse Events
Losartan 50 mg/HCTZ 12.5 mg
Serious events: 11 serious events
Other events: 56 other events
Deaths: 0 deaths
Valsartan 80 mg/HCTZ 12.5 mg
Serious events: 5 serious events
Other events: 57 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Losartan 50 mg/HCTZ 12.5 mg
n=425 participants at risk
Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
|
Valsartan 80 mg/HCTZ 12.5 mg
n=383 participants at risk
Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.24%
1/425 • Number of events 1
|
0.00%
0/383
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.24%
1/425 • Number of events 1
|
0.00%
0/383
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.24%
1/425 • Number of events 1
|
0.00%
0/383
|
|
General disorders
Chest pain
|
0.00%
0/425
|
0.26%
1/383 • Number of events 1
|
|
Infections and infestations
Pneumonia klebsiella
|
0.24%
1/425 • Number of events 1
|
0.00%
0/383
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/425
|
0.26%
1/383 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.24%
1/425 • Number of events 1
|
0.00%
0/383
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.24%
1/425 • Number of events 1
|
0.00%
0/383
|
|
Nervous system disorders
Cerebrovascular accident
|
0.24%
1/425 • Number of events 1
|
0.00%
0/383
|
|
Nervous system disorders
Critical illness polyneuropathy
|
0.24%
1/425 • Number of events 1
|
0.00%
0/383
|
|
Nervous system disorders
Syncope
|
0.24%
1/425 • Number of events 1
|
0.52%
2/383 • Number of events 2
|
|
Psychiatric disorders
Completed suicide
|
0.24%
1/425 • Number of events 1
|
0.00%
0/383
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/425
|
0.26%
1/383 • Number of events 1
|
|
Renal and urinary disorders
Renal failure acute
|
0.24%
1/425 • Number of events 1
|
0.00%
0/383
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/425
|
0.26%
1/383 • Number of events 1
|
Other adverse events
| Measure |
Losartan 50 mg/HCTZ 12.5 mg
n=425 participants at risk
Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
|
Valsartan 80 mg/HCTZ 12.5 mg
n=383 participants at risk
Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/425
|
0.26%
1/383 • Number of events 1
|
|
Eye disorders
Visual disturbance
|
0.24%
1/425 • Number of events 1
|
0.00%
0/383
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/425
|
0.26%
1/383 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.71%
3/425 • Number of events 3
|
0.26%
1/383 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.71%
3/425 • Number of events 3
|
0.00%
0/383
|
|
General disorders
Dyspepsia
|
0.00%
0/425
|
0.26%
1/383 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
0.24%
1/425 • Number of events 1
|
0.00%
0/383
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.24%
1/425 • Number of events 1
|
0.00%
0/383
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/425
|
0.26%
1/383 • Number of events 1
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.47%
2/425 • Number of events 2
|
0.00%
0/383
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/425
|
0.26%
1/383 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/425
|
0.52%
2/383 • Number of events 2
|
|
General disorders
Asthenia
|
0.24%
1/425 • Number of events 1
|
0.26%
1/383 • Number of events 1
|
|
General disorders
Chest discomfort
|
0.24%
1/425 • Number of events 1
|
0.00%
0/383
|
|
General disorders
Chest pain
|
0.24%
1/425 • Number of events 1
|
0.00%
0/383
|
|
General disorders
Fatigue
|
0.24%
1/425 • Number of events 1
|
0.00%
0/383
|
|
General disorders
Feeling abnormal
|
0.24%
1/425 • Number of events 1
|
0.00%
0/383
|
|
General disorders
Inflammation
|
0.00%
0/425
|
0.26%
1/383 • Number of events 1
|
|
General disorders
Malaise
|
0.00%
0/425
|
0.26%
1/383 • Number of events 1
|
|
General disorders
Pain
|
0.24%
1/425 • Number of events 1
|
0.00%
0/383
|
|
General disorders
Slugishness
|
0.24%
1/425 • Number of events 1
|
0.00%
0/383
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/425
|
0.52%
2/383 • Number of events 2
|
|
Infections and infestations
Bronchitis
|
0.24%
1/425 • Number of events 1
|
0.26%
1/383 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/425
|
0.26%
1/383 • Number of events 1
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/425
|
0.26%
1/383 • Number of events 1
|
|
Infections and infestations
Influenza
|
0.24%
1/425 • Number of events 1
|
0.00%
0/383
|
|
Infections and infestations
Mastitis
|
0.00%
0/425
|
0.26%
1/383 • Number of events 1
|
|
Infections and infestations
Rhinitis
|
0.24%
1/425 • Number of events 1
|
0.00%
0/383
|
|
Infections and infestations
Sinusitis
|
0.24%
1/425 • Number of events 1
|
0.00%
0/383
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/425
|
0.26%
1/383 • Number of events 1
|
|
Injury, poisoning and procedural complications
Back injury
|
0.24%
1/425 • Number of events 1
|
0.26%
1/383 • Number of events 1
|
|
Injury, poisoning and procedural complications
Back sprain
|
0.24%
1/425 • Number of events 1
|
0.00%
0/383
|
|
Injury, poisoning and procedural complications
Incorrect does administered
|
0.00%
0/425
|
0.26%
1/383 • Number of events 1
|
|
Injury, poisoning and procedural complications
Neck injury
|
0.00%
0/425
|
0.26%
1/383 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wrong technique in drug usage process
|
0.00%
0/425
|
0.52%
2/383 • Number of events 2
|
|
Investigations
Blood creatinine increased
|
0.47%
2/425 • Number of events 2
|
0.00%
0/383
|
|
Investigations
Blood glucose increased
|
0.00%
0/425
|
0.26%
1/383 • Number of events 1
|
|
Investigations
Blood potassium abnormal
|
0.00%
0/425
|
0.26%
1/383 • Number of events 1
|
|
Investigations
Blood potassium increased
|
0.71%
3/425 • Number of events 3
|
0.26%
1/383 • Number of events 1
|
|
Investigations
Blood pressure decreased
|
0.00%
0/425
|
0.26%
1/383 • Number of events 1
|
|
Investigations
C-Reactive protein increased
|
1.6%
7/425 • Number of events 7
|
0.78%
3/383 • Number of events 3
|
|
Investigations
Cardiac murmur
|
0.24%
1/425 • Number of events 1
|
0.00%
0/383
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/425
|
0.26%
1/383 • Number of events 1
|
|
Investigations
Heart rate increased
|
0.24%
1/425 • Number of events 1
|
0.00%
0/383
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/425
|
0.26%
1/383 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.24%
1/425 • Number of events 1
|
0.26%
1/383 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.24%
1/425 • Number of events 1
|
0.00%
0/383
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/425
|
0.26%
1/383 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.47%
2/425 • Number of events 2
|
0.26%
1/383 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/425
|
0.26%
1/383 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.24%
1/425 • Number of events 1
|
0.00%
0/383
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/425
|
0.52%
2/383 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.24%
1/425 • Number of events 1
|
0.00%
0/383
|
|
Nervous system disorders
Dizziness
|
0.71%
3/425 • Number of events 3
|
1.0%
4/383 • Number of events 4
|
|
Nervous system disorders
Headache
|
0.94%
4/425 • Number of events 4
|
1.0%
4/383 • Number of events 4
|
|
Nervous system disorders
Tremor
|
0.00%
0/425
|
0.26%
1/383 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.24%
1/425 • Number of events 1
|
0.26%
1/383 • Number of events 1
|
|
Psychiatric disorders
Depression
|
0.00%
0/425
|
0.26%
1/383 • Number of events 1
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/425
|
0.26%
1/383 • Number of events 1
|
|
Psychiatric disorders
Renal impairment
|
0.00%
0/425
|
0.26%
1/383 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/425
|
0.26%
1/383 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.47%
2/425 • Number of events 2
|
0.00%
0/383
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.24%
1/425 • Number of events 1
|
0.00%
0/383
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.24%
1/425 • Number of events 1
|
0.00%
0/383
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/425
|
0.26%
1/383 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/425
|
0.26%
1/383 • Number of events 1
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.00%
0/425
|
0.26%
1/383 • Number of events 1
|
|
Vascular disorders
Hot flush
|
0.00%
0/425
|
0.26%
1/383 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.00%
0/425
|
0.26%
1/383 • Number of events 1
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER