Vytorin Reexamination Study (0653A-174)

• Sponsor: Organon and Co (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01070966
• Collaborator: (none)
• Enrollment: 2,089
• Duration (Months): 57

Study Details

Study Description

Brief Summary

This survey is conducted for preparing application material for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of VYTORIN through collecting the safety and efficacy information according to the Re-examination Regulation for New Drugs.

Condition or Disease	Intervention/Treatment	Phase
Primary Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH)

Study Design

• Study Type: Observational
• Actual Enrollment: 2089 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of VYTORIN in Usual Practice
• Study Start Date: Jul 1, 2005
• Actual Primary Completion Date: Apr 1, 2010
• Actual Study Completion Date: Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
VYTORIN® 10/10 (ezetimibe 10 mg/simvastatin 10 mg tablets) Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) treated with VYTORIN® 10/10 (ezetimibe 10 mg/simvastatin 10 mg tablets)
VYTORIN® 10/20 (ezetimibe 10 mg/simvastatin 20 mg tablets) Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) treated with VYTORIN® 10/20 (ezetimibe 10 mg/simvastatin 20 mg tablets)
VYTORIN® 10/40 (ezetimibe 10 mg/simvastatin 40 mg tablets) Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) treated with VYTORIN® 10/40 (ezetimibe 10 mg/simvastatin 40 mg tablets)
VYTORIN® 10/80 (ezetimibe 10 mg/simvastatin 80 mg tablets) Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) treated with VYTORIN® 10/80 (ezetimibe 10 mg/simvastatin 80 mg tablets)

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Any Clinical and/or Laboratory Adverse Experiences While Taking VYTORIN® Within 14 Days After Treatment Discontinuation [Up to 14 days after the treatment discontinuation]

   Participants who recieved VYTORIN and experienced any adverse event related or unrelated to VYTORIN®, within 14 days after treatment.

2. Mean Percent Change From Baseline to Treatment in Lipid Parameters [Baseline and up to 5 years]

   The 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participants Who Receives Vytorin In Usual Medical Practice Within Local Label For The First Time

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Organon and Co

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT01070966
• Other Study ID Numbers: 0653A-174; 2010_010
• First Posted: Feb 18, 2010
• Last Update Posted: Feb 9, 2022
• Last Verified: Feb 1, 2022

• Keywords provided by Organon and Co: Atherosclerosis
• Additional relevant MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia

Study Results

Participant Flow

Arm/Group Title	VYTORIN® 10/10 mg/Day to 10/80 mg/Day
Arm/Group Description	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.
Period Title: Participants for Safety Evaluation
STARTED	2089
COMPLETED	2011
NOT COMPLETED	78
Period Title: Participants for Safety Evaluation
STARTED	2011
COMPLETED	1929
NOT COMPLETED	82

Baseline Characteristics

Arm/Group Title	VYTORIN® 10/10 mg/Day to 10/80 mg/Day
Arm/Group Description	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.
Overall Participants	2011
Age, Customized (Number) [Number]
10 ≤age <20	5 0.2%
20 ≤age <30	22 1.1%
30 ≤age <40	111 5.5%
40 ≤age <50	391 19.4%
50 ≤age <60	598 29.7%
60 ≤age <70	600 29.8%
70 ≤age <80	256 12.7%
80 ≤age <90	28 1.4%
Sex/Gender, Customized (participants) [Number]
Male	930 46.2%
Female	1081 53.8%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Any Clinical and/or Laboratory Adverse Experiences While Taking VYTORIN® Within 14 Days After Treatment Discontinuation
Description	Participants who recieved VYTORIN and experienced any adverse event related or unrelated to VYTORIN®, within 14 days after treatment.
Time Frame	Up to 14 days after the treatment discontinuation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Participants Treated With VYTORIN
Arm/Group Description	Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Years 1 to 6.
Measure Participants	2011
Number [Percentage of Participants]	5.72 0.3%

2. Primary Outcome

Title	Mean Percent Change From Baseline to Treatment in Lipid Parameters
Description	The 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.
Time Frame	Baseline and up to 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Participants Baseline Lipid Parameters	Participants Treatment Lipid Parameters	Participants Percent Change
Arm/Group Description	Participants baseline lipid parameters for Total Cholesterol, HDL cholesterol, LDL cholesterol and Triglyceride.	Participants treatment lipid parameters for Total Cholesterol, HDL cholesterol, LDL cholesterol and Triglyceride.
Measure Participants	2011	2011	2011
TC (n = 1965, 1993, 1956)	231.31 (46.33)	173.00 (40.78)	-23.90 (17.45)
HDL (n = 1805, 1782, 1705)	49.64 (13.42)	49.85 (13.17)	2.06 (15.27)
LDL (n = 1096, 1128, 1012)	151.32 (39.09)	104.34 (37.09)	-28.93 (23.52)
TG (n = 1843, 1824, 1766)	200.07 (128.76)	168.33 (102.82)	-7.37 (41.99)

Adverse Events

Time Frame	Year 1 through Year 6. There were no SAE's reported in Year three.
Arm/Group Title	VYTORIN YEAR 1		VYTORIN YEAR 2		VYTORIN YEAR 4		VYTORIN YEAR 5		VYTORIN YEAR 6
Arm/Group Description	Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 1		Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 2		Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 4		Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 5		Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 6
All Cause Mortality
	VYTORIN YEAR 1		VYTORIN YEAR 2		VYTORIN YEAR 4		VYTORIN YEAR 5		VYTORIN YEAR 6
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	VYTORIN YEAR 1		VYTORIN YEAR 2		VYTORIN YEAR 4		VYTORIN YEAR 5		VYTORIN YEAR 6
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		4/933 (0.4%)		6/531 (1.1%)		0/380 (0%)		5/158 (3.2%)
Cardiac disorders
CARDIAC ARREST	0/9 (0%)	0	0/933 (0%)	0	1/531 (0.2%)	1	0/380 (0%)	0	0/158 (0%)	0
CORONARY ARTERY DISEASE	0/9 (0%)	0	0/933 (0%)	0	1/531 (0.2%)	1	0/380 (0%)	0	0/158 (0%)	0
Ear and labyrinth disorders
VERTIGO POSITIONAL	0/9 (0%)	0	1/933 (0.1%)	1	0/531 (0%)	0	0/380 (0%)	0	0/158 (0%)	0
Eye disorders
DIABETIC RETINOPATHY	0/9 (0%)	0	0/933 (0%)	0	0/531 (0%)	0	0/380 (0%)	0	1/158 (0.6%)	1
Gastrointestinal disorders
GASTRIC ULCER	0/9 (0%)	0	1/933 (0.1%)	1	0/531 (0%)	0	0/380 (0%)	0	0/158 (0%)	0
GASTROINTESTINAL HAEMORRHAGE	0/9 (0%)	0	0/933 (0%)	0	1/531 (0.2%)	1	0/380 (0%)	0	0/158 (0%)	0
RETROPERITONEAL HAEMATOMA	0/9 (0%)	0	0/933 (0%)	0	1/531 (0.2%)	1	0/380 (0%)	0	0/158 (0%)	0
Hepatobiliary disorders
CHOLECYSTITIS ACUTE	0/9 (0%)	0	0/933 (0%)	0	1/531 (0.2%)	1	0/380 (0%)	0	0/158 (0%)	0
Infections and infestations
HERPES ZOSTER	0/9 (0%)	0	1/933 (0.1%)	1	1/531 (0.2%)	1	0/380 (0%)	0	0/158 (0%)	0
PYELONEPHRITIS ACUTE	0/9 (0%)	0	0/933 (0%)	0	0/531 (0%)	0	0/380 (0%)	0	1/158 (0.6%)	1
Metabolism and nutrition disorders
DIABETIC FOOT	0/9 (0%)	0	1/933 (0.1%)	1	0/531 (0%)	0	0/380 (0%)	0	0/158 (0%)	0
Musculoskeletal and connective tissue disorders
BACK PAIN	0/9 (0%)	0	0/933 (0%)	0	0/531 (0%)	0	0/380 (0%)	0	1/158 (0.6%)	1
GOUTY ARTHRITIS	0/9 (0%)	0	0/933 (0%)	0	0/531 (0%)	0	0/380 (0%)	0	1/158 (0.6%)	1
SPINAL COLUMN STENOSIS	0/9 (0%)	0	0/933 (0%)	0	0/531 (0%)	0	0/380 (0%)	0	1/158 (0.6%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CERVIX CARCINOMA RECURRENT	0/9 (0%)	0	0/933 (0%)	0	1/531 (0.2%)	1	0/380 (0%)	0	0/158 (0%)	0
Nervous system disorders
SYNCOPE	0/9 (0%)	0	0/933 (0%)	0	1/531 (0.2%)	1	0/380 (0%)	0	0/158 (0%)	0
Respiratory, thoracic and mediastinal disorders
DYSPNOEA	0/9 (0%)	0	0/933 (0%)	0	1/531 (0.2%)	1	0/380 (0%)	0	0/158 (0%)	0
Other (Not Including Serious) Adverse Events
	VYTORIN YEAR 1		VYTORIN YEAR 2		VYTORIN YEAR 4		VYTORIN YEAR 5		VYTORIN YEAR 6
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/933 (0%)		0/531 (0%)		0/380 (0%)		0/158 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.