Trial Outcomes & Findings for Vytorin Reexamination Study (0653A-174) (NCT NCT01070966)
NCT ID: NCT01070966
Last Updated: 2022-02-09
Results Overview
Participants who recieved VYTORIN and experienced any adverse event related or unrelated to VYTORIN®, within 14 days after treatment.
Recruitment status
COMPLETED
Target enrollment
2089 participants
Primary outcome timeframe
Up to 14 days after the treatment discontinuation
Results posted on
2022-02-09
Participant Flow
Participant milestones
| Measure |
VYTORIN® 10/10 mg/Day to 10/80 mg/Day
Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH)treated with VYTORIN® dosages ranging from 10/10(ezetimibe 10 mg/simvastatin 10 mg tablets)a day to 10/80(ezetimibe 10 mg/simvastatin 80 mg tablets)a day.
|
|---|---|
|
Participants for Safety Evaluation
STARTED
|
2089
|
|
Participants for Safety Evaluation
COMPLETED
|
2011
|
|
Participants for Safety Evaluation
NOT COMPLETED
|
78
|
|
Participants for Efficacy Evaluation
STARTED
|
2011
|
|
Participants for Efficacy Evaluation
COMPLETED
|
1929
|
|
Participants for Efficacy Evaluation
NOT COMPLETED
|
82
|
Reasons for withdrawal
| Measure |
VYTORIN® 10/10 mg/Day to 10/80 mg/Day
Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH)treated with VYTORIN® dosages ranging from 10/10(ezetimibe 10 mg/simvastatin 10 mg tablets)a day to 10/80(ezetimibe 10 mg/simvastatin 80 mg tablets)a day.
|
|---|---|
|
Participants for Safety Evaluation
Violation of inclusion criteria
|
59
|
|
Participants for Safety Evaluation
Off-label use
|
9
|
|
Participants for Safety Evaluation
Duplicate Participants
|
4
|
|
Participants for Safety Evaluation
Violation inclusion criteria/off label
|
3
|
|
Participants for Safety Evaluation
TMT given before date of contract
|
3
|
|
Participants for Efficacy Evaluation
Lack of tmt period (<28 days)
|
61
|
|
Participants for Efficacy Evaluation
No efficacy evaluation
|
19
|
|
Participants for Efficacy Evaluation
Efficacy evaluation window violation
|
2
|
Baseline Characteristics
Vytorin Reexamination Study (0653A-174)
Baseline characteristics by cohort
| Measure |
VYTORIN® 10/10 mg/Day to 10/80 mg/Day
n=2011 Participants
Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) treated with VYTORIN® ranging from 10/10 mg/day through 10/80 mg/day for Years 1 to 6.
|
|---|---|
|
Age, Customized
10 ≤age <20
|
5 Participants
n=5 Participants
|
|
Age, Customized
20 ≤age <30
|
22 Participants
n=5 Participants
|
|
Age, Customized
30 ≤age <40
|
111 Participants
n=5 Participants
|
|
Age, Customized
40 ≤age <50
|
391 Participants
n=5 Participants
|
|
Age, Customized
50 ≤age <60
|
598 Participants
n=5 Participants
|
|
Age, Customized
60 ≤age <70
|
600 Participants
n=5 Participants
|
|
Age, Customized
70 ≤age <80
|
256 Participants
n=5 Participants
|
|
Age, Customized
80 ≤age <90
|
28 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
930 participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
1081 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 14 days after the treatment discontinuationParticipants who recieved VYTORIN and experienced any adverse event related or unrelated to VYTORIN®, within 14 days after treatment.
Outcome measures
| Measure |
Participants Treated With VYTORIN
n=2011 Participants
Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Years 1 to 6.
|
Participants Treatment Lipid Parameters
Participants treatment lipid parameters for Total Cholesterol, HDL cholesterol, LDL cholesterol and Triglyceride.
|
Participants Percent Change
|
|---|---|---|---|
|
Percentage of Participants With Any Clinical and/or Laboratory Adverse Experiences While Taking VYTORIN® Within 14 Days After Treatment Discontinuation
|
5.72 Percentage of Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and up to 5 yearsThe mean percent change from baseline to treatment in lipid parameters (total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides\[TG\]) and overall efficacy was evaluated by the investigator to show if there was any(improved, unchanged, worsened) lipid parameters over a period of approximately 5 years.
Outcome measures
| Measure |
Participants Treated With VYTORIN
n=2011 Participants
Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Years 1 to 6.
|
Participants Treatment Lipid Parameters
n=2011 Participants
Participants treatment lipid parameters for Total Cholesterol, HDL cholesterol, LDL cholesterol and Triglyceride.
|
Participants Percent Change
n=2011 Participants
|
|---|---|---|---|
|
Mean Percent Change From Baseline to Treatment in Lipid Parameters
TC (n = 1965, 1993, 1956)
|
231.31 percentage change
Standard Deviation 46.33
|
173.00 percentage change
Standard Deviation 40.78
|
-23.90 percentage change
Standard Deviation 17.45
|
|
Mean Percent Change From Baseline to Treatment in Lipid Parameters
HDL (n = 1805, 1782, 1705)
|
49.64 percentage change
Standard Deviation 13.42
|
49.85 percentage change
Standard Deviation 13.17
|
2.06 percentage change
Standard Deviation 15.27
|
|
Mean Percent Change From Baseline to Treatment in Lipid Parameters
LDL (n = 1096, 1128, 1012)
|
151.32 percentage change
Standard Deviation 39.09
|
104.34 percentage change
Standard Deviation 37.09
|
-28.93 percentage change
Standard Deviation 23.52
|
|
Mean Percent Change From Baseline to Treatment in Lipid Parameters
TG (n = 1843, 1824, 1766)
|
200.07 percentage change
Standard Deviation 128.76
|
168.33 percentage change
Standard Deviation 102.82
|
-7.37 percentage change
Standard Deviation 41.99
|
Adverse Events
VYTORIN YEAR 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
VYTORIN YEAR 2
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
VYTORIN YEAR 4
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
VYTORIN YEAR 5
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
VYTORIN YEAR 6
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VYTORIN YEAR 1
n=9 participants at risk
Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 1
|
VYTORIN YEAR 2
n=933 participants at risk
Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 2
|
VYTORIN YEAR 4
n=531 participants at risk
Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 4
|
VYTORIN YEAR 5
n=380 participants at risk
Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 5
|
VYTORIN YEAR 6
n=158 participants at risk
Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 6
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
RETROPERITONEAL HAEMATOMA
|
0.00%
0/9 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/933 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.19%
1/531 • Number of events 1 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/380 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/158 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.00%
0/9 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/933 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.19%
1/531 • Number of events 1 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/380 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/158 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
|
Infections and infestations
HERPES ZOSTER
|
0.00%
0/9 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.11%
1/933 • Number of events 1 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.19%
1/531 • Number of events 1 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/380 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/158 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
|
Infections and infestations
PYELONEPHRITIS ACUTE
|
0.00%
0/9 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/933 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/531 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/380 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.63%
1/158 • Number of events 1 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
|
Metabolism and nutrition disorders
DIABETIC FOOT
|
0.00%
0/9 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.11%
1/933 • Number of events 1 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/531 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/380 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/158 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
|
Cardiac disorders
CARDIAC ARREST
|
0.00%
0/9 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/933 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.19%
1/531 • Number of events 1 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/380 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/158 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.00%
0/9 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/933 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.19%
1/531 • Number of events 1 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/380 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/158 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
|
Ear and labyrinth disorders
VERTIGO POSITIONAL
|
0.00%
0/9 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.11%
1/933 • Number of events 1 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/531 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/380 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/158 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
|
Eye disorders
DIABETIC RETINOPATHY
|
0.00%
0/9 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/933 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/531 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/380 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.63%
1/158 • Number of events 1 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
0.00%
0/9 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.11%
1/933 • Number of events 1 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/531 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/380 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/158 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/9 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/933 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.19%
1/531 • Number of events 1 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/380 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/158 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/9 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/933 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/531 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/380 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.63%
1/158 • Number of events 1 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
|
Musculoskeletal and connective tissue disorders
GOUTY ARTHRITIS
|
0.00%
0/9 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/933 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/531 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/380 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.63%
1/158 • Number of events 1 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
|
Musculoskeletal and connective tissue disorders
SPINAL COLUMN STENOSIS
|
0.00%
0/9 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/933 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/531 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/380 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.63%
1/158 • Number of events 1 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CERVIX CARCINOMA RECURRENT
|
0.00%
0/9 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/933 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.19%
1/531 • Number of events 1 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/380 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/158 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/9 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/933 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.19%
1/531 • Number of events 1 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/380 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/158 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/9 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/933 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.19%
1/531 • Number of events 1 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/380 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
0.00%
0/158 • Year 1 through Year 6. There were no SAE's reported in Year three.
|
Other adverse events
Adverse event data not reported
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
- Publication restrictions are in place