Trial Outcomes & Findings for EZETROL® Re-examination Study (MK0653-175)(COMPLETED) (NCT NCT01070953)
NCT ID: NCT01070953
Last Updated: 2022-02-09
Results Overview
Participants who recieved EZETROL® and experienced any adverse event related or unrelated to EZETROL®, within 14 days after treatment.
Recruitment status
COMPLETED
Target enrollment
4467 participants
Primary outcome timeframe
Up to 14 days after treatment discontinuation
Results posted on
2022-02-09
Participant Flow
Participant milestones
| Measure |
EZETROL® 10 mg
Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily.
|
|---|---|
|
Participants for Safety Evaluation
STARTED
|
4467
|
|
Participants for Safety Evaluation
COMPLETED
|
3536
|
|
Participants for Safety Evaluation
NOT COMPLETED
|
931
|
|
Participants for Efficacy Evaluation
STARTED
|
3536
|
|
Participants for Efficacy Evaluation
COMPLETED
|
3309
|
|
Participants for Efficacy Evaluation
NOT COMPLETED
|
227
|
Reasons for withdrawal
| Measure |
EZETROL® 10 mg
Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily.
|
|---|---|
|
Participants for Safety Evaluation
Violation of inclusion criteria
|
612
|
|
Participants for Safety Evaluation
Off-label use
|
283
|
|
Participants for Safety Evaluation
Duplicated participants
|
22
|
|
Participants for Safety Evaluation
Treatment prior to date of contract
|
8
|
|
Participants for Safety Evaluation
Uncontracted participants
|
4
|
|
Participants for Safety Evaluation
Violation of inclusions & off label use
|
1
|
|
Participants for Safety Evaluation
Duplicated participants & off-label use
|
1
|
|
Participants for Efficacy Evaluation
No efficacy evaluation
|
119
|
|
Participants for Efficacy Evaluation
Lack of treatment period (<28 days)
|
106
|
|
Participants for Efficacy Evaluation
Unknown date of efficacy evaluation
|
2
|
Baseline Characteristics
EZETROL® Re-examination Study (MK0653-175)(COMPLETED)
Baseline characteristics by cohort
| Measure |
EZETROL® 10 mg
n=3536 Participants
Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily.
|
|---|---|
|
Age, Customized
age < 20
|
4 participants
n=5 Participants
|
|
Age, Customized
20 ≤ age < 30
|
25 participants
n=5 Participants
|
|
Age, Customized
30 ≤ age < 40
|
186 participants
n=5 Participants
|
|
Age, Customized
40 ≤ age < 50
|
682 participants
n=5 Participants
|
|
Age, Customized
50 ≤ age < 60
|
1091 participants
n=5 Participants
|
|
Age, Customized
60 ≤ age < 70
|
1023 participants
n=5 Participants
|
|
Age, Customized
70 ≤ age < 80
|
451 participants
n=5 Participants
|
|
Age, Customized
80 ≤ age < 90
|
72 participants
n=5 Participants
|
|
Age, Customized
age ≥ 90
|
2 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1861 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1675 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 14 days after treatment discontinuationParticipants who recieved EZETROL® and experienced any adverse event related or unrelated to EZETROL®, within 14 days after treatment.
Outcome measures
| Measure |
EZETROL® 10 mg
n=4467 Participants
Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily.
|
|---|---|
|
Participants With Any Clinical and/or Laboratory Adverse Experience While Being Treated With EZETROL® Within 14 Days After Treatment Discontinuation
|
257 participants
|
PRIMARY outcome
Timeframe: Baseline to 4 weeksPopulation: 3,309 subjects were analyzed for the efficacy evaluation; 227 of the enrolled subjects did not complete the study and were excluded
The mean percent change from baseline to treatment in lipid parameters (total cholesterol \[TC\], low-density lipoprotein \[LDL\] cholesterol, high-density lipoprotein \[HDL\] cholesterol, triglycerides\[TG\]) in participants who received EZETROL over 4 weeks and then had available laboratory results in Lipid Parameters.
Outcome measures
| Measure |
EZETROL® 10 mg
n=3309 Participants
Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily.
|
|---|---|
|
Mean Percent Change From Baseline to Treatment in Lipid Parameters
TC (n = 2439)
|
-21.23 percentage of change
Standard Deviation 21.16
|
|
Mean Percent Change From Baseline to Treatment in Lipid Parameters
HDL (n = 1928)
|
3.47 percentage of change
Standard Deviation 19.81
|
|
Mean Percent Change From Baseline to Treatment in Lipid Parameters
LDL (n = 1774)
|
-24.06 percentage of change
Standard Deviation 33.49
|
|
Mean Percent Change From Baseline to Treatment in Lipid Parameters
TG ( n = 2083)
|
-10.37 percentage of change
Standard Deviation 45.05
|
PRIMARY outcome
Timeframe: Baseline to 4 weeksPopulation: 3,309 subjects were analyzed for the efficacy evaluation; 227 of the enrolled subjects did not complete the study and were excluded
Participants who received EZETROL over 4 weeks and then have been evaluated for overall efficacy assessment by investigator showing to be improved, unchanged or worsened.
Outcome measures
| Measure |
EZETROL® 10 mg
n=3309 Participants
Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily.
|
|---|---|
|
Overall Efficacy Evaluation of EZETROL®
Improved
|
3029 participants
|
|
Overall Efficacy Evaluation of EZETROL®
Unchanged
|
241 participants
|
|
Overall Efficacy Evaluation of EZETROL®
Worsened
|
39 participants
|
|
Overall Efficacy Evaluation of EZETROL®
Total
|
3309 participants
|
Adverse Events
EZETROL Year 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
EZETROL Year 2
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
EZETROL Year 3
Serious events: 18 serious events
Other events: 3 other events
Deaths: 0 deaths
EZETROL Year 4
Serious events: 9 serious events
Other events: 0 other events
Deaths: 0 deaths
EZETROL Year 5
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
EZETROL Year 6
Serious events: 2 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
EZETROL Year 1
n=67 participants at risk
Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 1.
|
EZETROL Year 2
n=1135 participants at risk
Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 2.
|
EZETROL Year 3
n=1039 participants at risk
Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 3.
|
EZETROL Year 4
n=766 participants at risk
Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 4.
|
EZETROL Year 5
n=154 participants at risk
Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 5.
|
EZETROL Year 6
n=375 participants at risk
Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 6.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.00%
0/67 • Year 1 through Year 6.
|
0.00%
0/1135 • Year 1 through Year 6.
|
0.10%
1/1039 • Number of events 1 • Year 1 through Year 6.
|
0.00%
0/766 • Year 1 through Year 6.
|
0.00%
0/154 • Year 1 through Year 6.
|
0.00%
0/375 • Year 1 through Year 6.
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.00%
0/67 • Year 1 through Year 6.
|
0.00%
0/1135 • Year 1 through Year 6.
|
0.38%
4/1039 • Number of events 4 • Year 1 through Year 6.
|
0.00%
0/766 • Year 1 through Year 6.
|
0.65%
1/154 • Number of events 1 • Year 1 through Year 6.
|
0.00%
0/375 • Year 1 through Year 6.
|
|
Cardiac disorders
ANGINA UNSTABLE
|
0.00%
0/67 • Year 1 through Year 6.
|
0.00%
0/1135 • Year 1 through Year 6.
|
0.10%
1/1039 • Number of events 1 • Year 1 through Year 6.
|
0.00%
0/766 • Year 1 through Year 6.
|
0.00%
0/154 • Year 1 through Year 6.
|
0.00%
0/375 • Year 1 through Year 6.
|
|
Cardiac disorders
CARDIAC DISORDER
|
0.00%
0/67 • Year 1 through Year 6.
|
0.09%
1/1135 • Number of events 1 • Year 1 through Year 6.
|
0.00%
0/1039 • Year 1 through Year 6.
|
0.00%
0/766 • Year 1 through Year 6.
|
0.00%
0/154 • Year 1 through Year 6.
|
0.00%
0/375 • Year 1 through Year 6.
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.00%
0/67 • Year 1 through Year 6.
|
0.00%
0/1135 • Year 1 through Year 6.
|
0.00%
0/1039 • Year 1 through Year 6.
|
0.13%
1/766 • Number of events 1 • Year 1 through Year 6.
|
0.00%
0/154 • Year 1 through Year 6.
|
0.00%
0/375 • Year 1 through Year 6.
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.00%
0/67 • Year 1 through Year 6.
|
0.00%
0/1135 • Year 1 through Year 6.
|
0.10%
1/1039 • Number of events 1 • Year 1 through Year 6.
|
0.13%
1/766 • Number of events 1 • Year 1 through Year 6.
|
0.00%
0/154 • Year 1 through Year 6.
|
0.00%
0/375 • Year 1 through Year 6.
|
|
Cardiac disorders
CARDIOGENIC SHOCK
|
0.00%
0/67 • Year 1 through Year 6.
|
0.00%
0/1135 • Year 1 through Year 6.
|
0.00%
0/1039 • Year 1 through Year 6.
|
0.00%
0/766 • Year 1 through Year 6.
|
0.00%
0/154 • Year 1 through Year 6.
|
0.27%
1/375 • Number of events 1 • Year 1 through Year 6.
|
|
Cardiac disorders
CORONARY ARTERY OCCLUSION
|
0.00%
0/67 • Year 1 through Year 6.
|
0.00%
0/1135 • Year 1 through Year 6.
|
0.10%
1/1039 • Number of events 1 • Year 1 through Year 6.
|
0.00%
0/766 • Year 1 through Year 6.
|
0.00%
0/154 • Year 1 through Year 6.
|
0.00%
0/375 • Year 1 through Year 6.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/67 • Year 1 through Year 6.
|
0.00%
0/1135 • Year 1 through Year 6.
|
0.00%
0/1039 • Year 1 through Year 6.
|
0.00%
0/766 • Year 1 through Year 6.
|
0.00%
0/154 • Year 1 through Year 6.
|
0.27%
1/375 • Number of events 1 • Year 1 through Year 6.
|
|
Ear and labyrinth disorders
DEAFNESS NEUROSENSORY
|
0.00%
0/67 • Year 1 through Year 6.
|
0.00%
0/1135 • Year 1 through Year 6.
|
0.00%
0/1039 • Year 1 through Year 6.
|
0.13%
1/766 • Number of events 1 • Year 1 through Year 6.
|
0.00%
0/154 • Year 1 through Year 6.
|
0.00%
0/375 • Year 1 through Year 6.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
0/67 • Year 1 through Year 6.
|
0.00%
0/1135 • Year 1 through Year 6.
|
0.00%
0/1039 • Year 1 through Year 6.
|
0.13%
1/766 • Number of events 1 • Year 1 through Year 6.
|
0.00%
0/154 • Year 1 through Year 6.
|
0.00%
0/375 • Year 1 through Year 6.
|
|
Gastrointestinal disorders
MELAENA
|
0.00%
0/67 • Year 1 through Year 6.
|
0.00%
0/1135 • Year 1 through Year 6.
|
0.00%
0/1039 • Year 1 through Year 6.
|
0.13%
1/766 • Number of events 1 • Year 1 through Year 6.
|
0.00%
0/154 • Year 1 through Year 6.
|
0.00%
0/375 • Year 1 through Year 6.
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/67 • Year 1 through Year 6.
|
0.00%
0/1135 • Year 1 through Year 6.
|
0.10%
1/1039 • Number of events 1 • Year 1 through Year 6.
|
0.00%
0/766 • Year 1 through Year 6.
|
0.00%
0/154 • Year 1 through Year 6.
|
0.00%
0/375 • Year 1 through Year 6.
|
|
Infections and infestations
PYELONEPHRITIS ACUTE
|
0.00%
0/67 • Year 1 through Year 6.
|
0.00%
0/1135 • Year 1 through Year 6.
|
0.10%
1/1039 • Number of events 1 • Year 1 through Year 6.
|
0.13%
1/766 • Number of events 1 • Year 1 through Year 6.
|
0.00%
0/154 • Year 1 through Year 6.
|
0.00%
0/375 • Year 1 through Year 6.
|
|
Injury, poisoning and procedural complications
EXTRADURAL HAEMATOMA
|
0.00%
0/67 • Year 1 through Year 6.
|
0.00%
0/1135 • Year 1 through Year 6.
|
0.00%
0/1039 • Year 1 through Year 6.
|
0.13%
1/766 • Number of events 1 • Year 1 through Year 6.
|
0.00%
0/154 • Year 1 through Year 6.
|
0.00%
0/375 • Year 1 through Year 6.
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.00%
0/67 • Year 1 through Year 6.
|
0.00%
0/1135 • Year 1 through Year 6.
|
0.00%
0/1039 • Year 1 through Year 6.
|
0.13%
1/766 • Number of events 1 • Year 1 through Year 6.
|
0.00%
0/154 • Year 1 through Year 6.
|
0.00%
0/375 • Year 1 through Year 6.
|
|
Injury, poisoning and procedural complications
HUMERUS FRACTURE
|
0.00%
0/67 • Year 1 through Year 6.
|
0.00%
0/1135 • Year 1 through Year 6.
|
0.00%
0/1039 • Year 1 through Year 6.
|
0.00%
0/766 • Year 1 through Year 6.
|
0.65%
1/154 • Number of events 1 • Year 1 through Year 6.
|
0.00%
0/375 • Year 1 through Year 6.
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.00%
0/67 • Year 1 through Year 6.
|
0.00%
0/1135 • Year 1 through Year 6.
|
0.10%
1/1039 • Number of events 1 • Year 1 through Year 6.
|
0.00%
0/766 • Year 1 through Year 6.
|
0.00%
0/154 • Year 1 through Year 6.
|
0.00%
0/375 • Year 1 through Year 6.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/67 • Year 1 through Year 6.
|
0.00%
0/1135 • Year 1 through Year 6.
|
0.10%
1/1039 • Number of events 1 • Year 1 through Year 6.
|
0.00%
0/766 • Year 1 through Year 6.
|
0.00%
0/154 • Year 1 through Year 6.
|
0.00%
0/375 • Year 1 through Year 6.
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.00%
0/67 • Year 1 through Year 6.
|
0.00%
0/1135 • Year 1 through Year 6.
|
0.10%
1/1039 • Number of events 1 • Year 1 through Year 6.
|
0.00%
0/766 • Year 1 through Year 6.
|
0.00%
0/154 • Year 1 through Year 6.
|
0.00%
0/375 • Year 1 through Year 6.
|
|
Musculoskeletal and connective tissue disorders
NEUROPATHIC ARTHROPATHY
|
0.00%
0/67 • Year 1 through Year 6.
|
0.00%
0/1135 • Year 1 through Year 6.
|
0.00%
0/1039 • Year 1 through Year 6.
|
0.13%
1/766 • Number of events 1 • Year 1 through Year 6.
|
0.00%
0/154 • Year 1 through Year 6.
|
0.00%
0/375 • Year 1 through Year 6.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/67 • Year 1 through Year 6.
|
0.00%
0/1135 • Year 1 through Year 6.
|
0.10%
1/1039 • Number of events 1 • Year 1 through Year 6.
|
0.00%
0/766 • Year 1 through Year 6.
|
0.00%
0/154 • Year 1 through Year 6.
|
0.00%
0/375 • Year 1 through Year 6.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATIC NEOPLASM MALIGNANT
|
0.00%
0/67 • Year 1 through Year 6.
|
0.18%
2/1135 • Number of events 2 • Year 1 through Year 6.
|
0.00%
0/1039 • Year 1 through Year 6.
|
0.00%
0/766 • Year 1 through Year 6.
|
0.00%
0/154 • Year 1 through Year 6.
|
0.00%
0/375 • Year 1 through Year 6.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PARATHYROID TUMOUR BENIGN
|
0.00%
0/67 • Year 1 through Year 6.
|
0.00%
0/1135 • Year 1 through Year 6.
|
0.00%
0/1039 • Year 1 through Year 6.
|
0.13%
1/766 • Number of events 1 • Year 1 through Year 6.
|
0.00%
0/154 • Year 1 through Year 6.
|
0.00%
0/375 • Year 1 through Year 6.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RECTAL CANCER
|
0.00%
0/67 • Year 1 through Year 6.
|
0.00%
0/1135 • Year 1 through Year 6.
|
0.10%
1/1039 • Number of events 1 • Year 1 through Year 6.
|
0.00%
0/766 • Year 1 through Year 6.
|
0.00%
0/154 • Year 1 through Year 6.
|
0.00%
0/375 • Year 1 through Year 6.
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
0.00%
0/67 • Year 1 through Year 6.
|
0.00%
0/1135 • Year 1 through Year 6.
|
0.10%
1/1039 • Number of events 1 • Year 1 through Year 6.
|
0.00%
0/766 • Year 1 through Year 6.
|
0.00%
0/154 • Year 1 through Year 6.
|
0.00%
0/375 • Year 1 through Year 6.
|
|
Nervous system disorders
DEMENTIA
|
0.00%
0/67 • Year 1 through Year 6.
|
0.00%
0/1135 • Year 1 through Year 6.
|
0.00%
0/1039 • Year 1 through Year 6.
|
0.13%
1/766 • Number of events 1 • Year 1 through Year 6.
|
0.00%
0/154 • Year 1 through Year 6.
|
0.00%
0/375 • Year 1 through Year 6.
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/67 • Year 1 through Year 6.
|
0.00%
0/1135 • Year 1 through Year 6.
|
0.00%
0/1039 • Year 1 through Year 6.
|
0.13%
1/766 • Number of events 1 • Year 1 through Year 6.
|
0.00%
0/154 • Year 1 through Year 6.
|
0.00%
0/375 • Year 1 through Year 6.
|
|
Nervous system disorders
NEUROLEPTIC MALIGNANT SYNDROME
|
0.00%
0/67 • Year 1 through Year 6.
|
0.00%
0/1135 • Year 1 through Year 6.
|
0.00%
0/1039 • Year 1 through Year 6.
|
0.00%
0/766 • Year 1 through Year 6.
|
0.65%
1/154 • Number of events 1 • Year 1 through Year 6.
|
0.00%
0/375 • Year 1 through Year 6.
|
|
Nervous system disorders
QUADRIPLEGIA
|
0.00%
0/67 • Year 1 through Year 6.
|
0.00%
0/1135 • Year 1 through Year 6.
|
0.10%
1/1039 • Number of events 1 • Year 1 through Year 6.
|
0.00%
0/766 • Year 1 through Year 6.
|
0.00%
0/154 • Year 1 through Year 6.
|
0.00%
0/375 • Year 1 through Year 6.
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/67 • Year 1 through Year 6.
|
0.00%
0/1135 • Year 1 through Year 6.
|
0.10%
1/1039 • Number of events 1 • Year 1 through Year 6.
|
0.00%
0/766 • Year 1 through Year 6.
|
0.00%
0/154 • Year 1 through Year 6.
|
0.00%
0/375 • Year 1 through Year 6.
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.00%
0/67 • Year 1 through Year 6.
|
0.00%
0/1135 • Year 1 through Year 6.
|
0.00%
0/1039 • Year 1 through Year 6.
|
0.00%
0/766 • Year 1 through Year 6.
|
0.65%
1/154 • Number of events 1 • Year 1 through Year 6.
|
0.00%
0/375 • Year 1 through Year 6.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/67 • Year 1 through Year 6.
|
0.00%
0/1135 • Year 1 through Year 6.
|
0.00%
0/1039 • Year 1 through Year 6.
|
0.13%
1/766 • Number of events 1 • Year 1 through Year 6.
|
0.00%
0/154 • Year 1 through Year 6.
|
0.00%
0/375 • Year 1 through Year 6.
|
|
Respiratory, thoracic and mediastinal disorders
VOCAL CORD POLYP
|
0.00%
0/67 • Year 1 through Year 6.
|
0.00%
0/1135 • Year 1 through Year 6.
|
0.10%
1/1039 • Number of events 1 • Year 1 through Year 6.
|
0.00%
0/766 • Year 1 through Year 6.
|
0.00%
0/154 • Year 1 through Year 6.
|
0.00%
0/375 • Year 1 through Year 6.
|
|
Vascular disorders
ANGIOPATHY
|
0.00%
0/67 • Year 1 through Year 6.
|
0.00%
0/1135 • Year 1 through Year 6.
|
0.10%
1/1039 • Number of events 1 • Year 1 through Year 6.
|
0.00%
0/766 • Year 1 through Year 6.
|
0.00%
0/154 • Year 1 through Year 6.
|
0.00%
0/375 • Year 1 through Year 6.
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/67 • Year 1 through Year 6.
|
0.00%
0/1135 • Year 1 through Year 6.
|
0.19%
2/1039 • Number of events 3 • Year 1 through Year 6.
|
0.00%
0/766 • Year 1 through Year 6.
|
0.00%
0/154 • Year 1 through Year 6.
|
0.00%
0/375 • Year 1 through Year 6.
|
Other adverse events
| Measure |
EZETROL Year 1
n=67 participants at risk
Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 1.
|
EZETROL Year 2
n=1135 participants at risk
Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 2.
|
EZETROL Year 3
n=1039 participants at risk
Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 3.
|
EZETROL Year 4
n=766 participants at risk
Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 4.
|
EZETROL Year 5
n=154 participants at risk
Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 5.
|
EZETROL Year 6
n=375 participants at risk
Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 6.
|
|---|---|---|---|---|---|---|
|
General disorders
FATIGUE
|
0.00%
0/67 • Year 1 through Year 6.
|
0.44%
5/1135 • Number of events 5 • Year 1 through Year 6.
|
0.29%
3/1039 • Number of events 3 • Year 1 through Year 6.
|
0.00%
0/766 • Year 1 through Year 6.
|
0.00%
0/154 • Year 1 through Year 6.
|
7.7%
29/375 • Number of events 29 • Year 1 through Year 6.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place