Trial Outcomes & Findings for To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 40 mg (0653-090) (NCT NCT00276484)
NCT ID: NCT00276484
Last Updated: 2024-05-14
Results Overview
Percent Change in LDL-C = \[(week 6 value - baseline value)/baseline value\]\*100%
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
579 participants
Primary outcome timeframe
Baseline and 6 weeks
Results posted on
2024-05-14
Participant Flow
Phase III First Patient In: 4/6/2006; Last Patient Last Visit 2/26/2008 96 centers worldwide (US, Canada) Eligible patients include those on a stable dose of atorvastatin 40 mg; or patients with adjusted LDLC pre-screen ranges who were treated with other lipid modifying therapy, or were statin and/or ezetimibe naïve.
Patients received and were blinded to atorvastatin 40 mg for a 4/5- week run-in period. Patients needed an LDL-C ≥ 70 mg/dL and ≤ 160 mg/dL at Visit 2 (week -1). Eligible patients were randomized at Visit 3 (Week 0) to either atorvastatin 80 mg or addition of ezetimibe 10 mg to their 40 mg dose of atorvastatin for a 6-week treatment period.
Participant milestones
| Measure |
Atorvastatin + Ezetemibe
Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
|
Atorvastatin
Atorvastatin 80 mg every day for 6 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
288
|
291
|
|
Overall Study
COMPLETED
|
279
|
278
|
|
Overall Study
NOT COMPLETED
|
9
|
13
|
Reasons for withdrawal
| Measure |
Atorvastatin + Ezetemibe
Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
|
Atorvastatin
Atorvastatin 80 mg every day for 6 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
7
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
|
Overall Study
Could not take time off work
|
0
|
1
|
Baseline Characteristics
To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 40 mg (0653-090)
Baseline characteristics by cohort
| Measure |
Atorvastatin + Ezetemibe
n=288 Participants
Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
|
Atorvastatin
n=291 Participants
Atorvastatin 80 mg every day for 6 weeks
|
Total
n=579 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.6 years
n=5 Participants
|
62 years
n=7 Participants
|
61.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
115 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
228 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
173 Participants
n=5 Participants
|
178 Participants
n=7 Participants
|
351 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
237 Participants
n=5 Participants
|
232 Participants
n=7 Participants
|
469 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
32 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multi-Racial
|
15 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Apolipoprotein A-I
|
154.0 mg/dL
STANDARD_DEVIATION 25.5 • n=5 Participants
|
154.6 mg/dL
STANDARD_DEVIATION 25.0 • n=7 Participants
|
154.3 mg/dL
STANDARD_DEVIATION 25.3 • n=5 Participants
|
|
Apolipoprotein B
|
101.3 mg/dL
STANDARD_DEVIATION 19.0 • n=5 Participants
|
102.0 mg/dL
STANDARD_DEVIATION 18.8 • n=7 Participants
|
101.7 mg/dL
STANDARD_DEVIATION 18.9 • n=5 Participants
|
|
Apolipoprotein B:Apolipoprotein A-I ratio
|
0.7 Ratio
STANDARD_DEVIATION 0.2 • n=5 Participants
|
0.7 Ratio
STANDARD_DEVIATION 0.2 • n=7 Participants
|
0.7 Ratio
STANDARD_DEVIATION 0.2 • n=5 Participants
|
|
C Reactive Protein
|
1.8 mg/dL
STANDARD_DEVIATION 2.7 • n=5 Participants
|
1.5 mg/dL
STANDARD_DEVIATION 3.0 • n=7 Participants
|
1.6 mg/dL
STANDARD_DEVIATION 2.8 • n=5 Participants
|
|
High-Density Lipoprotein
|
47.4 mg/dL
STANDARD_DEVIATION 10.5 • n=5 Participants
|
47.2 mg/dL
STANDARD_DEVIATION 10.6 • n=7 Participants
|
47.3 mg/dL
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Low-Density Lipoprotein
|
88.8 mg/dL
STANDARD_DEVIATION 16.2 • n=5 Participants
|
89.8 mg/dL
STANDARD_DEVIATION 16.2 • n=7 Participants
|
89.4 mg/dL
STANDARD_DEVIATION 16.2 • n=5 Participants
|
|
Low-Density Lipoprotein-C:High-Density Lipoprotein-C ratio
|
2.0 Ratio
STANDARD_DEVIATION 0.6 • n=5 Participants
|
2.0 Ratio
STANDARD_DEVIATION 0.6 • n=7 Participants
|
2.0 Ratio
STANDARD_DEVIATION 0.6 • n=5 Participants
|
|
Non-High-Density Lipoprotein Cholesterol
|
117.7 mg/dL
STANDARD_DEVIATION 20.8 • n=5 Participants
|
118.1 mg/dL
STANDARD_DEVIATION 21.9 • n=7 Participants
|
117.9 mg/dL
STANDARD_DEVIATION 21.4 • n=5 Participants
|
|
Non-High-Density Lipoprotein-C:High-Density Lipoprotein-C ratio
|
2.6 Ratio
STANDARD_DEVIATION 0.8 • n=5 Participants
|
2.6 Ratio
STANDARD_DEVIATION 0.8 • n=7 Participants
|
2.6 Ratio
STANDARD_DEVIATION 0.8 • n=5 Participants
|
|
Total Cholesterol
|
165.2 mg/dL
STANDARD_DEVIATION 21.4 • n=5 Participants
|
165.3 mg/dL
STANDARD_DEVIATION 22.8 • n=7 Participants
|
165.2 mg/dL
STANDARD_DEVIATION 22.1 • n=5 Participants
|
|
Total cholesterol:High-Density Lipoprotein-C ratio
|
3.6 Ratio
STANDARD_DEVIATION 0.8 • n=5 Participants
|
3.6 Ratio
STANDARD_DEVIATION 0.8 • n=7 Participants
|
3.6 Ratio
STANDARD_DEVIATION 0.8 • n=5 Participants
|
|
Triglycerides
|
132.5 mg/dL
STANDARD_DEVIATION 72.1 • n=5 Participants
|
134.0 mg/dL
STANDARD_DEVIATION 72.1 • n=7 Participants
|
133.5 mg/dL
STANDARD_DEVIATION 72.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 weeksPopulation: Full Analysis Set (FAS): The FAS population includes all randomized patients who took at least 1 dose of study medication and had a baseline (BL) value and at least one post BL value. Post BL measurements up to 3 days following the last dose of double-blind study medication were included in the analysis.
Percent Change in LDL-C = \[(week 6 value - baseline value)/baseline value\]\*100%
Outcome measures
| Measure |
Atorvastatin + Ezetemibe
n=277 Participants
Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
|
Atorvastatin
n=279 Participants
Atorvastatin 80 mg every day for 6 weeks
|
|---|---|---|
|
Percent Change From Baseline to Week 6 in Low-Density Lipoprotein (LDL)-C
|
-27.4 Percent Change
Interval -29.6 to -25.1
|
-11.0 Percent Change
Interval -13.2 to -8.8
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: Full Analysis Set
Percent Change in HDL-C = \[(week 6 value - baseline value)/baseline value\]\*100%
Outcome measures
| Measure |
Atorvastatin + Ezetemibe
n=277 Participants
Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
|
Atorvastatin
n=279 Participants
Atorvastatin 80 mg every day for 6 weeks
|
|---|---|---|
|
Percent Change From Baseline to Week 6 in High-Density Lipoprotein Cholesterol (HDL-C)
|
-0.5 Percent Change
Interval -1.6 to 0.7
|
-1.0 Percent Change
Interval -2.1 to 0.2
|
SECONDARY outcome
Timeframe: Baseline and 6 WeeksPopulation: Full Analysis Set
Percent Change in Non-HDL-C = \[(week 6 value - baseline value)/baseline value\]\*100%
Outcome measures
| Measure |
Atorvastatin + Ezetemibe
n=277 Participants
Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
|
Atorvastatin
n=279 Participants
Atorvastatin 80 mg every day for 6 weeks
|
|---|---|---|
|
Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C)
|
-23.3 Percent Change
Interval -25.3 to -21.4
|
-9.0 Percent Change
Interval -11.0 to -7.1
|
SECONDARY outcome
Timeframe: Baseline and 6 WeeksPopulation: Full Analysis Set
Percent Change in Total-C = \[(week 6 value - baseline value)/baseline value\]\*100%
Outcome measures
| Measure |
Atorvastatin + Ezetemibe
n=277 Participants
Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
|
Atorvastatin
n=279 Participants
Atorvastatin 80 mg every day for 6 weeks
|
|---|---|---|
|
Percent Change From Baseline to Week 6 in Total-Cholesterol
|
-16.9 Percent Change
Interval -18.3 to -15.4
|
-6.9 Percent Change
Interval -8.4 to -5.5
|
SECONDARY outcome
Timeframe: Baseline and 6 WeeksPopulation: Full Analysis Set
Percent Change in TG = \[(week 6 value - baseline value)/baseline value\]\*100%
Outcome measures
| Measure |
Atorvastatin + Ezetemibe
n=277 Participants
Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
|
Atorvastatin
n=279 Participants
Atorvastatin 80 mg every day for 6 weeks
|
|---|---|---|
|
Percent Change From Baseline to Week 6 in Triglycerides (TG)
|
-12.3 Percent Change
Interval -16.3 to -8.2
|
-5.9 Percent Change
Interval -10.2 to -0.7
|
SECONDARY outcome
Timeframe: Baseline and 6 WeeksPopulation: Full Analysis Set
Percent Change in Apo B = \[(week 6 value - baseline value)/baseline value\]\*100%
Outcome measures
| Measure |
Atorvastatin + Ezetemibe
n=275 Participants
Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
|
Atorvastatin
n=276 Participants
Atorvastatin 80 mg every day for 6 weeks
|
|---|---|---|
|
Percent Change From Baseline to Week 6 in Apolipoprotein B (Apo B)
|
-17.8 Percent Change
Interval -19.6 to -16.0
|
-7.7 Percent Change
Interval -9.5 to -5.8
|
SECONDARY outcome
Timeframe: Baseline and 6 WeeksPopulation: Full Analysis Set
Percent Change in Apo A-I = \[(week 6 value - baseline value)/baseline value\]\*100%
Outcome measures
| Measure |
Atorvastatin + Ezetemibe
n=275 Participants
Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
|
Atorvastatin
n=276 Participants
Atorvastatin 80 mg every day for 6 weeks
|
|---|---|---|
|
Percent Change From Baseline to Week 6 in Apolipoprotein A-I (Apo A-I)
|
-0.3 Percent Change
Interval -1.5 to 0.9
|
-1.2 Percent Change
Interval -2.3 to 0.0
|
SECONDARY outcome
Timeframe: Baseline and 6 WeeksPercent Change in TC:HDL-C Ratio = \[(week 6 ratio - baseline ratio)/baseline ratio\]\*100%
Outcome measures
| Measure |
Atorvastatin + Ezetemibe
n=277 Participants
Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
|
Atorvastatin
n=279 Participants
Atorvastatin 80 mg every day for 6 weeks
|
|---|---|---|
|
Percent Change From Baseline to Week 6 in Total-Cholesterol (TC):High-Density Lipoprotein Cholesterol (HDL-C) Ratio
|
-16.0 Percent Change
Interval -176.6 to -14.4
|
-5.6 Percent Change
Interval -7.2 to -4.1
|
SECONDARY outcome
Timeframe: Baseline and 6 WeeksPopulation: Full Analysis Set
Percent Change in LDL-C:HDL-C Ratio = \[(week 6 ratio - baseline ratio)/baseline ratio\]\*100%
Outcome measures
| Measure |
Atorvastatin + Ezetemibe
n=277 Participants
Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
|
Atorvastatin
n=279 Participants
Atorvastatin 80 mg every day for 6 weeks
|
|---|---|---|
|
Percent Change From Baseline to Week 6 in Low-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (LDL-C:HDL-C) Ratio
|
-26.4 Percent change
Interval -28.8 to -24.0
|
-9.9 Percent change
Interval -12.3 to -7.5
|
SECONDARY outcome
Timeframe: Baseline and 6 WeeksPopulation: Full Analysis Set
Percent Change in Apo B:Apo A-I Ratio = \[(week 6 ratio - baseline ratio)/baseline ratio\]\*100%
Outcome measures
| Measure |
Atorvastatin + Ezetemibe
n=275 Participants
Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
|
Atorvastatin
n=276 Participants
Atorvastatin 80 mg every day for 6 weeks
|
|---|---|---|
|
Percent Change From Baseline to Week 6 in Apolipoprotein B:Apolipoprotein A-I (Apo B:Apo A-I) Ratio
|
-16.9 Percent Change
Interval -18.9 to -14.9
|
-5.9 Percent Change
Interval -7.9 to -3.9
|
SECONDARY outcome
Timeframe: Baseline and 6 WeeksPopulation: Full Analysis Set
Percent Change in non-HDL-C:HDL-C Ratio = \[(week 6 ratio - baseline ratio)/baseline ratio\]\*100%
Outcome measures
| Measure |
Atorvastatin + Ezetemibe
n=277 Participants
Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
|
Atorvastatin
n=279 Participants
Atorvastatin 80 mg every day for 6 weeks
|
|---|---|---|
|
Percent Change From Baseline to Week 6 in Non-High-Density Lipoprotein-Cholesterol:High-Density Lipoprotein-Cholesterol (Non-HDL-C:HDL-C) Ratio
|
-22.2 Percent Change
Interval -24.5 to -19.9
|
-7.6 Percent Change
Interval -9.9 to -5.4
|
SECONDARY outcome
Timeframe: Baseline and 6 WeeksPopulation: Full Analysis Set
Percent Change in CRP = \[(week 6 value - baseline value)/baseline value\]\*100%
Outcome measures
| Measure |
Atorvastatin + Ezetemibe
n=277 Participants
Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
|
Atorvastatin
n=276 Participants
Atorvastatin 80 mg every day for 6 weeks
|
|---|---|---|
|
Percent Change From Baseline to Week 6 in C Reactive Protein (CRP)
|
-18.3 Percent Change
Interval -25.0 to -11.1
|
-11.5 Percent Change
Interval -18.7 to -3.6
|
SECONDARY outcome
Timeframe: 6 WeeksPopulation: Full Analysis Set
Outcome measures
| Measure |
Atorvastatin + Ezetemibe
n=277 Participants
Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
|
Atorvastatin
n=279 Participants
Atorvastatin 80 mg every day for 6 weeks
|
|---|---|---|
|
Number of Patients Who Attained Target Low-Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6
<70 mg/dL
|
204 Participants
|
88 Participants
|
|
Number of Patients Who Attained Target Low-Density Lipoprotein Cholesterol (LDL-C) <70 mg/dL at Week 6
>=70 mg/dL
|
73 Participants
|
191 Participants
|
Adverse Events
Atorvastatin + Ezetemibe
Serious events: 9 serious events
Other events: 63 other events
Deaths: 0 deaths
Atorvastatin
Serious events: 5 serious events
Other events: 61 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Atorvastatin + Ezetemibe
Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
|
Atorvastatin
Atorvastatin 80 mg every day for 6 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/286
|
0.35%
1/289
|
|
Cardiac disorders
Cardiac failure congestive
|
0.35%
1/286
|
0.00%
0/289
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/286
|
0.35%
1/289
|
|
Cardiac disorders
Myocardial infarction
|
1.0%
3/286
|
0.35%
1/289
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/286
|
0.35%
1/289
|
|
General disorders
Chest pain
|
0.35%
1/286
|
0.00%
0/289
|
|
General disorders
Hernia obstructive
|
0.00%
0/286
|
0.35%
1/289
|
|
General disorders
Non-cardiac chest pain
|
0.35%
1/286
|
0.00%
0/289
|
|
Infections and infestations
Pneumonia
|
0.35%
1/286
|
0.00%
0/289
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/286
|
0.35%
1/289
|
|
Nervous system disorders
Presyncope
|
0.35%
1/286
|
0.00%
0/289
|
|
Psychiatric disorders
Mental status
|
0.00%
0/286
|
0.35%
1/289
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.35%
1/286
|
0.00%
0/289
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.35%
1/286
|
0.00%
0/289
|
|
Vascular disorders
Hypertensive crisis
|
0.35%
1/286
|
0.00%
0/289
|
|
Vascular disorders
Labile hypertension
|
0.35%
1/286
|
0.00%
0/289
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/286
|
0.35%
1/289
|
Other adverse events
| Measure |
Atorvastatin + Ezetemibe
Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
|
Atorvastatin
Atorvastatin 80 mg every day for 6 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.35%
1/286
|
0.35%
1/289
|
|
Cardiac disorders
Cardiac failure congestive
|
0.35%
1/286
|
0.00%
0/289
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/286
|
0.35%
1/289
|
|
Cardiac disorders
Myocardial infarction
|
1.0%
3/286
|
0.35%
1/289
|
|
Ear and labyrinth disorders
Vertigo
|
0.35%
1/286
|
0.00%
0/289
|
|
Eye disorders
Retinal detachment
|
0.35%
1/286
|
0.00%
0/289
|
|
Eye disorders
Vision blurred
|
0.70%
2/286
|
0.35%
1/289
|
|
Eye disorders
Visual disturbance
|
0.00%
0/286
|
0.35%
1/289
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/286
|
0.35%
1/289
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/286
|
0.35%
1/289
|
|
Gastrointestinal disorders
Abdominal pain
|
0.70%
2/286
|
0.69%
2/289
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/286
|
0.35%
1/289
|
|
Gastrointestinal disorders
Constipation
|
0.35%
1/286
|
0.69%
2/289
|
|
Gastrointestinal disorders
Dental caries
|
0.35%
1/286
|
0.00%
0/289
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/286
|
2.1%
6/289
|
|
Gastrointestinal disorders
Diverticulum
|
0.35%
1/286
|
0.00%
0/289
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/286
|
0.69%
2/289
|
|
Gastrointestinal disorders
Dysphagia
|
0.35%
1/286
|
0.00%
0/289
|
|
Gastrointestinal disorders
Flatulence
|
0.35%
1/286
|
0.00%
0/289
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/286
|
0.35%
1/289
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.35%
1/286
|
0.00%
0/289
|
|
Gastrointestinal disorders
Gingivitis
|
0.35%
1/286
|
0.00%
0/289
|
|
Gastrointestinal disorders
Nausea
|
0.70%
2/286
|
0.69%
2/289
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.35%
1/286
|
0.35%
1/289
|
|
Gastrointestinal disorders
Vomiting
|
0.35%
1/286
|
0.35%
1/289
|
|
General disorders
Chest pain
|
1.0%
3/286
|
0.69%
2/289
|
|
General disorders
Fatigue
|
0.00%
0/286
|
1.4%
4/289
|
|
General disorders
Hernia obstructive
|
0.00%
0/286
|
0.35%
1/289
|
|
General disorders
Non-cardiac chest pain
|
0.35%
1/286
|
0.00%
0/289
|
|
General disorders
Oedema peripheral
|
0.70%
2/286
|
0.35%
1/289
|
|
General disorders
Pyrexia
|
0.00%
0/286
|
0.35%
1/289
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.35%
1/286
|
0.00%
0/289
|
|
Immune system disorders
Seasonal allergy
|
0.35%
1/286
|
0.35%
1/289
|
|
Infections and infestations
Bronchitis
|
1.4%
4/286
|
0.35%
1/289
|
|
Infections and infestations
Chronic sinusitis
|
0.35%
1/286
|
0.00%
0/289
|
|
Infections and infestations
Conjunctivitis infective
|
0.00%
0/286
|
0.35%
1/289
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/286
|
0.35%
1/289
|
|
Infections and infestations
Nasopharyngitis
|
1.4%
4/286
|
0.35%
1/289
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/286
|
0.35%
1/289
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/286
|
0.35%
1/289
|
|
Infections and infestations
Pneumonia
|
0.35%
1/286
|
0.00%
0/289
|
|
Infections and infestations
Sinusitis
|
0.70%
2/286
|
0.35%
1/289
|
|
Infections and infestations
Upper respiratory tract infection
|
0.35%
1/286
|
2.4%
7/289
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/286
|
0.35%
1/289
|
|
Injury, poisoning and procedural complications
Back injury
|
0.35%
1/286
|
0.00%
0/289
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.35%
1/286
|
0.00%
0/289
|
|
Injury, poisoning and procedural complications
Contusion
|
0.70%
2/286
|
0.00%
0/289
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/286
|
0.35%
1/289
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/286
|
0.35%
1/289
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/286
|
0.35%
1/289
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.35%
1/286
|
0.00%
0/289
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.35%
1/286
|
0.00%
0/289
|
|
General disorders
Alanine aminotransferase
|
0.70%
2/286
|
0.69%
2/289
|
|
General disorders
Aspartate aminotransferase
|
0.70%
2/286
|
0.69%
2/289
|
|
General disorders
Blood bilirubin increased
|
0.00%
0/286
|
0.35%
1/289
|
|
General disorders
Blood creatine phosphokinase increased
|
0.70%
2/286
|
0.00%
0/289
|
|
General disorders
Blood potassium increased
|
0.70%
2/286
|
0.00%
0/289
|
|
General disorders
Blood uric acid increased
|
0.35%
1/286
|
0.00%
0/289
|
|
General disorders
Carotid pulse decreased
|
0.35%
1/286
|
0.00%
0/289
|
|
General disorders
Gamma-glutamyltransferase increased
|
0.70%
2/286
|
0.35%
1/289
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/286
|
1.4%
4/289
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/286
|
1.0%
3/289
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.35%
1/286
|
0.00%
0/289
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.35%
1/286
|
0.00%
0/289
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/286
|
0.69%
2/289
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.35%
1/286
|
0.00%
0/289
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/286
|
0.35%
1/289
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.35%
1/286
|
1.7%
5/289
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.4%
4/286
|
1.0%
3/289
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/286
|
0.35%
1/289
|
|
Nervous system disorders
Cerebellar ataxia
|
0.35%
1/286
|
0.00%
0/289
|
|
Nervous system disorders
Dizziness
|
1.0%
3/286
|
0.69%
2/289
|
|
Nervous system disorders
Headache
|
1.4%
4/286
|
0.69%
2/289
|
|
Nervous system disorders
Migraine
|
0.35%
1/286
|
0.00%
0/289
|
|
Nervous system disorders
Paraesthesia
|
0.35%
1/286
|
0.00%
0/289
|
|
Nervous system disorders
Presyncope
|
0.35%
1/286
|
0.00%
0/289
|
|
Nervous system disorders
Sciatica
|
0.00%
0/286
|
0.35%
1/289
|
|
Nervous system disorders
Syncope
|
0.35%
1/286
|
0.00%
0/289
|
|
Psychiatric disorders
Anxiety
|
0.35%
1/286
|
0.35%
1/289
|
|
Psychiatric disorders
Confusional state
|
0.35%
1/286
|
0.00%
0/289
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/286
|
0.35%
1/289
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/286
|
0.35%
1/289
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/286
|
0.35%
1/289
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.35%
1/286
|
0.00%
0/289
|
|
Renal and urinary disorders
Renal cyst
|
0.35%
1/286
|
0.00%
0/289
|
|
Renal and urinary disorders
Renal failure
|
0.35%
1/286
|
0.00%
0/289
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.35%
1/286
|
0.35%
1/289
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/286
|
0.35%
1/289
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/286
|
0.35%
1/289
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.35%
1/286
|
0.00%
0/289
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.35%
1/286
|
0.35%
1/289
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/286
|
0.35%
1/289
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.0%
3/286
|
0.35%
1/289
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/286
|
0.35%
1/289
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.35%
1/286
|
0.00%
0/289
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.35%
1/286
|
0.00%
0/289
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.35%
1/286
|
0.35%
1/289
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/286
|
0.35%
1/289
|
|
General disorders
Cataract operation
|
0.00%
0/286
|
0.35%
1/289
|
|
General disorders
Inguinal hernia repair
|
0.35%
1/286
|
0.00%
0/289
|
|
Vascular disorders
Haematoma
|
0.00%
0/286
|
0.35%
1/289
|
|
Vascular disorders
Hypertension
|
0.35%
1/286
|
0.00%
0/289
|
|
Vascular disorders
Hypertensive crisis
|
0.35%
1/286
|
0.00%
0/289
|
|
Vascular disorders
Hypotension
|
0.35%
1/286
|
0.00%
0/289
|
|
Vascular disorders
Labile hypertension
|
0.35%
1/286
|
0.00%
0/289
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/286
|
0.35%
1/289
|
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