Trial Outcomes & Findings for A Study to Assess the Cholesterol Lowering Effect of an Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Patients With High Cholesterol and With High Cardiovascular Risk (0653A-809)(COMPLETED) (NCT NCT00479713)
NCT ID: NCT00479713
Last Updated: 2024-05-16
Results Overview
Percent Change in LDL-C at study endpoint after six weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure \*100.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
618 participants
Primary outcome timeframe
Baseline and 6 weeks
Results posted on
2024-05-16
Participant Flow
Phase IV First Participant In: 31-Mar-2007; Last Participant Last Visit 11-Mar-2008 85 centers worldwide (EX US) Eligible participants include those on a stable dose of one of the following: rosuvastatin 5 mg; simvastatin 20 mg, 40 mg; atorvastatin 10, 20 mg; pravastatin 40 mg; fluvastatin 80 mg.
Eligible participants were randomized at Visit 2 (Week 6) to either a combination tablet of ezetimibe/simvastatin (10 mg/20 mg) plus a matching placebo for rosuvastatin 10 mg (Group 1) or rosuvastatin 10 mg plus a matching placebo for the combination tablet (Group 2) for a 6-week treatment period.
Participant milestones
| Measure |
Ezetemibe + Simvastatin
Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
|
Rosuvastatin
Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
314
|
304
|
|
Overall Study
COMPLETED
|
301
|
295
|
|
Overall Study
NOT COMPLETED
|
13
|
9
|
Reasons for withdrawal
| Measure |
Ezetemibe + Simvastatin
Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
|
Rosuvastatin
Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
8
|
6
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
Baseline Characteristics
A Study to Assess the Cholesterol Lowering Effect of an Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Patients With High Cholesterol and With High Cardiovascular Risk (0653A-809)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Ezetemibe + Simvastatin
n=314 Participants
Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
|
Rosuvastatin
n=304 Participants
Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
|
Total
n=618 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.2 years
n=99 Participants
|
63.1 years
n=107 Participants
|
63.15 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
129 Participants
n=99 Participants
|
119 Participants
n=107 Participants
|
248 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
185 Participants
n=99 Participants
|
185 Participants
n=107 Participants
|
370 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
314 participants
n=99 Participants
|
302 participants
n=107 Participants
|
616 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
37 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
277 Participants
n=99 Participants
|
261 Participants
n=107 Participants
|
538 Participants
n=206 Participants
|
|
Apolipoprotein B
|
1.20 mg/dL
STANDARD_DEVIATION 0.20 • n=99 Participants
|
1.18 mg/dL
STANDARD_DEVIATION 0.21 • n=107 Participants
|
1.19 mg/dL
STANDARD_DEVIATION 0.21 • n=206 Participants
|
|
C Reactive Protein
|
0.16 mg/dL
STANDARD_DEVIATION 0.26 • n=99 Participants
|
0.15 mg/dL
STANDARD_DEVIATION 0.26 • n=107 Participants
|
0.16 mg/dL
STANDARD_DEVIATION 0.26 • n=206 Participants
|
|
High Density Lipoprotein-Cholesterol
|
1.43 mg/dL
STANDARD_DEVIATION 0.37 • n=99 Participants
|
1.43 mg/dL
STANDARD_DEVIATION 0.36 • n=107 Participants
|
1.43 mg/dL
STANDARD_DEVIATION 0.36 • n=206 Participants
|
|
Low Density Lipoprotein-Cholesterol (LDL-C)
|
3.21 mg/dL
STANDARD_DEVIATION 0.42 • n=99 Participants
|
3.24 mg/dL
STANDARD_DEVIATION 0.44 • n=107 Participants
|
3.23 mg/dL
STANDARD_DEVIATION 0.43 • n=206 Participants
|
|
Low Density Lipoprotein-Cholesterol (LDL-C):High Density Lipoprotein-Cholesterol (HDL-C) ratio
|
2.38 LDL-C:HDL-C ratio
STANDARD_DEVIATION 0.65 • n=99 Participants
|
2.40 LDL-C:HDL-C ratio
STANDARD_DEVIATION 0.65 • n=107 Participants
|
2.39 LDL-C:HDL-C ratio
STANDARD_DEVIATION 0.65 • n=206 Participants
|
|
Non-High Density Lipoprotein-Cholesterol (Non-HDL-C)
|
3.95 mg/dL
STANDARD_DEVIATION 0.55 • n=99 Participants
|
3.95 mg/dL
STANDARD_DEVIATION 0.56 • n=107 Participants
|
3.95 mg/dL
STANDARD_DEVIATION 0.55 • n=206 Participants
|
|
Total Cholesterol
|
5.38 mg/dL
STANDARD_DEVIATION 0.57 • n=99 Participants
|
5.38 mg/dL
STANDARD_DEVIATION 0.61 • n=107 Participants
|
5.38 mg/dL
STANDARD_DEVIATION 0.59 • n=206 Participants
|
|
Total cholesterol:High Density Lipoprotein-Cholesterol (HDL-C) ratio
|
3.94 Total cholesterol:HDL-C ratio
STANDARD_DEVIATION 0.89 • n=99 Participants
|
3.96 Total cholesterol:HDL-C ratio
STANDARD_DEVIATION 0.90 • n=107 Participants
|
3.95 Total cholesterol:HDL-C ratio
STANDARD_DEVIATION 0.90 • n=206 Participants
|
|
Triglycerides
|
1.46 mg/dL
STANDARD_DEVIATION 0.86 • n=99 Participants
|
1.41 mg/dL
STANDARD_DEVIATION 0.87 • n=107 Participants
|
1.42 mg/dL
STANDARD_DEVIATION 0.88 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 weeksPopulation: Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value.
Percent Change in LDL-C at study endpoint after six weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure \*100.
Outcome measures
| Measure |
Ezetemibe + Simvastatin
n=305 Participants
Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
|
Rosuvastatin
n=297 Participants
Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
|
|---|---|---|
|
Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) at Study Endpoint After Six Weeks of Treatment
|
-27.66 percent change from baseline
Interval -30.27 to -25.04
|
-16.94 percent change from baseline
Interval -19.61 to -14.28
|
SECONDARY outcome
Timeframe: after 6 weeks of treatmentPopulation: Full Analysis Set (FAS)
The percentage of participants who achieved a target LDL-C goal of \< 100 mg/dL, of \<70 mg/dL, and of \<77 mg/dL at study endpoint after six weeks of treatment. The numerator is the number of participants in a treatment group who achieved a target LDL-C goal and the denominator is the total number of participants within that treatment group.
Outcome measures
| Measure |
Ezetemibe + Simvastatin
n=305 Participants
Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
|
Rosuvastatin
n=297 Participants
Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
|
|---|---|---|
|
The Percentage of Participants Achieving Designated Low Density Lipoprotein-Cholesterol (LDL-C) Levels After 6 Weeks of Treatment
LDL-C <100
|
72.46 Percent of participant population
|
56.23 Percent of participant population
|
|
The Percentage of Participants Achieving Designated Low Density Lipoprotein-Cholesterol (LDL-C) Levels After 6 Weeks of Treatment
LDL-C <70
|
25.25 Percent of participant population
|
11.11 Percent of participant population
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 6 weeksPopulation: Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value.
Percent change from baseline in total cholesterol at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure \*100.
Outcome measures
| Measure |
Ezetemibe + Simvastatin
n=305 Participants
Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
|
Rosuvastatin
n=297 Participants
Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
|
|---|---|---|
|
Percent Change From Baseline in Total Cholesterol
|
-17.53 percent change from baseline
Interval -19.36 to -15.71
|
-10.33 percent change from baseline
Interval -12.19 to -8.47
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 6 weeksPopulation: Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value.
Percent change from baseline in triglycerides at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure \*100.
Outcome measures
| Measure |
Ezetemibe + Simvastatin
n=305 Participants
Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
|
Rosuvastatin
n=297 Participants
Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
|
|---|---|---|
|
Percent Change From Baseline in Triglycerides.
|
-11.00 percent change from baseline
Interval -15.25 to -6.8
|
-5.26 percent change from baseline
Interval -9.92 to -1.17
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 6 weeksPopulation: Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value.
Percent change from baseline in HDL-C at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure \*100.
Outcome measures
| Measure |
Ezetemibe + Simvastatin
n=305 Participants
Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
|
Rosuvastatin
n=297 Participants
Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
|
|---|---|---|
|
Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C)
|
2.12 percent change from baseline
Interval 0.34 to 3.89
|
3.03 percent change from baseline
Interval 1.22 to 4.85
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 6 weeksPopulation: Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value.
Percent change from baseline in non HDL-C at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure \*100.
Outcome measures
| Measure |
Ezetemibe + Simvastatin
n=305 Participants
Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
|
Rosuvastatin
n=297 Participants
Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
|
|---|---|---|
|
Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C)
|
-23.42 percent change from baseline
Interval -25.81 to 21.03
|
-14.01 percent change from baseline
Interval -16.46 to -11.57
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 6 weeksPopulation: Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value.
Percent change from baseline in LDL-C/HDL-C ratio at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure \*100.
Outcome measures
| Measure |
Ezetemibe + Simvastatin
n=305 Participants
Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
|
Rosuvastatin
n=297 Participants
Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
|
|---|---|---|
|
Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C)/High Density Lipoprotein-Cholesterol (HDL-C) Ratio
|
-27.41 percent change from baseline
Interval -30.42 to -24.4
|
-17.82 percent change from baseline
Interval -20.89 to -14.75
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 6 weeksPopulation: Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value.
Percent change from baseline in total cholesterol/HDL-C ratio at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure \*100.
Outcome measures
| Measure |
Ezetemibe + Simvastatin
n=305 Participants
Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
|
Rosuvastatin
n=297 Participants
Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
|
|---|---|---|
|
Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-Cholesterol (HDL-C) Ratio
|
-17.76 percent change from baseline
Interval -19.94 to -15.57
|
-11.51 percent change from baseline
Interval -13.74 to -9.28
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 6 weeksPopulation: Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value.
Percent change from baseline in apolipoprotein (Apo) B at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure \*100.
Outcome measures
| Measure |
Ezetemibe + Simvastatin
n=301 Participants
Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
|
Rosuvastatin
n=292 Participants
Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
|
|---|---|---|
|
Percent Change From Baseline in Apolipoprotein B
|
-17.87 percent change from baseline
Interval -20.05 to -15.7
|
-9.77 percent change from baseline
Interval -11.99 to -7.55
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 6 weeksPopulation: Full Analysis Set (FAS): The FAS population includes all randomized participants who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value.
Percent change from baseline in hs-C reactive protein at study endpoint after 6 weeks of treatment is calculated as the difference between week 6 measure and baseline measure divided by baseline measure \*100.
Outcome measures
| Measure |
Ezetemibe + Simvastatin
n=301 Participants
Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
|
Rosuvastatin
n=293 Participants
Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
|
|---|---|---|
|
Percent Change From Baseline in High-sensitivity C (Hs-C) Reactive Protein
|
-8.33 percent change from baseline
Interval -16.67 to 0.0
|
0.00 percent change from baseline
Interval -7.14 to 6.25
|
Adverse Events
Ezetemibe + Simvastatin
Serious events: 3 serious events
Other events: 19 other events
Deaths: 0 deaths
Rosuvastatin
Serious events: 5 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ezetemibe + Simvastatin
Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
|
Rosuvastatin
Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
|
|---|---|---|
|
Hepatobiliary disorders
Cholangitis
|
0.32%
1/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.00%
0/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.32%
1/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.00%
0/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Nervous system disorders
Subarachnoid hemorrhage
|
0.32%
1/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.00%
0/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.66%
2/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Nervous system disorders
Epileptic seizure
|
0.00%
0/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.33%
1/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin eruption
|
0.00%
0/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.33%
1/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
In-stent arterial restenosis
|
0.00%
0/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.33%
1/304
Adverse event tables include all participants who took at least one dose of study drug.
|
Other adverse events
| Measure |
Ezetemibe + Simvastatin
Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
|
Rosuvastatin
Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
|
|---|---|---|
|
Cardiac disorders
Angina unstable
|
0.32%
1/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.00%
0/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Cardiac disorders
Bradycardia
|
0.32%
1/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.00%
0/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.64%
2/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.66%
2/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.32%
1/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.33%
1/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.96%
3/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.33%
1/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.33%
1/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.96%
3/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.33%
1/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.64%
2/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.00%
0/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.32%
1/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.00%
0/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomitting
|
0.64%
2/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.00%
0/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.33%
1/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
General disorders
Chest pain
|
0.32%
1/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.00%
0/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.33%
1/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Immune system disorders
Hypersensitivity
|
0.32%
1/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.00%
0/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Immune system disorders
Seasonal allergy
|
0.32%
1/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.00%
0/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Infections and infestations
Ear infection
|
0.00%
0/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.33%
1/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.33%
1/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.33%
1/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Infections and infestations
Localised infection
|
0.00%
0/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.33%
1/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.32%
1/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.00%
0/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Infections and infestations
Paronychia
|
0.00%
0/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.33%
1/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
0.32%
1/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.00%
0/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Infections and infestations
Sinusitis
|
0.32%
1/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.00%
0/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.33%
1/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.33%
1/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Deafness traumatic
|
0.32%
1/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.00%
0/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.32%
1/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.00%
0/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.32%
1/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.00%
0/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.33%
1/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Investigations
Blood pressure increased
|
0.00%
0/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.33%
1/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.32%
1/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.00%
0/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.33%
1/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.33%
1/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.32%
1/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.00%
0/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.96%
3/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.66%
2/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.32%
1/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.00%
0/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
0.00%
0/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.33%
1/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.33%
1/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.33%
1/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
0.32%
1/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.00%
0/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.33%
1/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.33%
1/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.33%
1/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.33%
1/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.33%
1/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.33%
1/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.00%
0/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.33%
1/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.33%
1/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.33%
1/304
Adverse event tables include all participants who took at least one dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.64%
2/312
Adverse event tables include all participants who took at least one dose of study drug.
|
0.00%
0/304
Adverse event tables include all participants who took at least one dose of study drug.
|
Additional Information
Vice President, Late Stage Development Group Leader
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
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