EZETROL® Re-examination Study (MK0653-175)(COMPLETED)

• Sponsor: Organon and Co (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01070953
• Collaborator: (none)
• Enrollment: 4,467
• Duration (Months): 65.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hypercholesterolemia

Study Design

• Study Type: Observational
• Actual Enrollment: 4467 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of EZETROL® in Usual Practice
• Study Start Date: Jan 1, 2005
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
EZETROL® 10 mg Participants with Hypercholesterolemia treated with EZETROL®

Outcome Measures

Primary Outcome Measures

1. Participants With Any Clinical and/or Laboratory Adverse Experience While Being Treated With EZETROL® Within 14 Days After Treatment Discontinuation [Up to 14 days after treatment discontinuation]

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

2. Mean Percent Change From Baseline to Treatment in Lipid Parameters [Baseline to 4 weeks]

   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.

3. Overall Efficacy Evaluation of EZETROL® [Baseline to 4 weeks]

   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.

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 EZETROL® In Usual Medical Practice

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Organon and Co

Investigators

• Study Director: Medical Monitor, Merck Sharp & Dohme LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT01070953
• Other Study ID Numbers: 0653-175; 2010_009
• First Posted: Feb 18, 2010
• Last Update Posted: Feb 9, 2022
• Last Verified: Feb 1, 2022

• Keywords provided by Organon and Co: Hypercholesterolemia
• Additional relevant MeSH terms: Hypercholesterolemia

Study Results

Participant Flow

Arm/Group Title	EZETROL® 10 mg
Arm/Group Description	Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily.
Period Title: Participants for Safety Evaluation
STARTED	4467
COMPLETED	3536
NOT COMPLETED	931
Period Title: Participants for Safety Evaluation
STARTED	3536
COMPLETED	3309
NOT COMPLETED	227

Baseline Characteristics

Arm/Group Title	EZETROL® 10 mg
Arm/Group Description	Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily.
Overall Participants	3536
Age, Customized (participants) [Number]
age < 20	4 0.1%
20 ≤ age < 30	25 0.7%
30 ≤ age < 40	186 5.3%
40 ≤ age < 50	682 19.3%
50 ≤ age < 60	1091 30.9%
60 ≤ age < 70	1023 28.9%
70 ≤ age < 80	451 12.8%
80 ≤ age < 90	72 2%
age ≥ 90	2 0.1%
Sex: Female, Male (Count of Participants)
Female	1861 52.6%
Male	1675 47.4%

Outcome Measures

1. Primary Outcome

Title	Participants With Any Clinical and/or Laboratory Adverse Experience While Being Treated With EZETROL® Within 14 Days After Treatment Discontinuation
Description	Participants who recieved EZETROL® and experienced any adverse event related or unrelated to EZETROL®, within 14 days after treatment.
Time Frame	Up to 14 days after treatment discontinuation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EZETROL® 10 mg
Arm/Group Description	Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily.
Measure Participants	4467
Number [participants]	257 7.3%

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 [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.
Time Frame	Baseline to 4 weeks

Outcome Measure Data

Analysis Population Description

3,309 subjects were analyzed for the efficacy evaluation; 227 of the enrolled subjects did not complete the study and were excluded

Arm/Group Title	All Participants
Arm/Group Description
Measure Participants	3309
TC (n = 2439)	-21.23 (21.16)
HDL (n = 1928)	3.47 (19.81)
LDL (n = 1774)	-24.06 (33.49)
TG ( n = 2083)	-10.37 (45.05)

3. Primary Outcome

Title	Overall Efficacy Evaluation of EZETROL®
Description	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.
Time Frame	Baseline to 4 weeks

Outcome Measure Data

Analysis Population Description

3,309 subjects were analyzed for the efficacy evaluation; 227 of the enrolled subjects did not complete the study and were excluded

Arm/Group Title	EZETROL® 10 mg
Arm/Group Description	Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily.
Measure Participants	3309
Improved	3029 85.7%
Unchanged	241 6.8%
Worsened	39 1.1%
Total	3309 93.6%

Adverse Events

Time Frame	Year 1 through Year 6.
Arm/Group Title	EZETROL Year 1		EZETROL Year 2		EZETROL Year 3		EZETROL Year 4		EZETROL Year 5		EZETROL Year 6
Arm/Group Description	Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 1.		Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 2.		Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 3.		Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 4.		Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 5.		Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 6.
All Cause Mortality
	EZETROL Year 1		EZETROL Year 2		EZETROL Year 3		EZETROL Year 4		EZETROL Year 5		EZETROL Year 6
	Affected / at Risk (%)	# Events	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)		/ (NaN)
Serious Adverse Events
	EZETROL Year 1		EZETROL Year 2		EZETROL Year 3		EZETROL Year 4		EZETROL Year 5		EZETROL Year 6
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/67 (0%)		3/1135 (0.3%)		18/1039 (1.7%)		9/766 (1.2%)		4/154 (2.6%)		2/375 (0.5%)
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION	0/67 (0%)	0	0/1135 (0%)	0	1/1039 (0.1%)	1	0/766 (0%)	0	0/154 (0%)	0	0/375 (0%)	0
ANGINA PECTORIS	0/67 (0%)	0	0/1135 (0%)	0	4/1039 (0.4%)	4	0/766 (0%)	0	1/154 (0.6%)	1	0/375 (0%)	0
ANGINA UNSTABLE	0/67 (0%)	0	0/1135 (0%)	0	1/1039 (0.1%)	1	0/766 (0%)	0	0/154 (0%)	0	0/375 (0%)	0
CARDIAC DISORDER	0/67 (0%)	0	1/1135 (0.1%)	1	0/1039 (0%)	0	0/766 (0%)	0	0/154 (0%)	0	0/375 (0%)	0
CARDIAC FAILURE	0/67 (0%)	0	0/1135 (0%)	0	0/1039 (0%)	0	1/766 (0.1%)	1	0/154 (0%)	0	0/375 (0%)	0
CARDIAC FAILURE CONGESTIVE	0/67 (0%)	0	0/1135 (0%)	0	1/1039 (0.1%)	1	1/766 (0.1%)	1	0/154 (0%)	0	0/375 (0%)	0
CARDIOGENIC SHOCK	0/67 (0%)	0	0/1135 (0%)	0	0/1039 (0%)	0	0/766 (0%)	0	0/154 (0%)	0	1/375 (0.3%)	1
CORONARY ARTERY OCCLUSION	0/67 (0%)	0	0/1135 (0%)	0	1/1039 (0.1%)	1	0/766 (0%)	0	0/154 (0%)	0	0/375 (0%)	0
MYOCARDIAL INFARCTION	0/67 (0%)	0	0/1135 (0%)	0	0/1039 (0%)	0	0/766 (0%)	0	0/154 (0%)	0	1/375 (0.3%)	1
Ear and labyrinth disorders
DEAFNESS NEUROSENSORY	0/67 (0%)	0	0/1135 (0%)	0	0/1039 (0%)	0	1/766 (0.1%)	1	0/154 (0%)	0	0/375 (0%)	0
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE	0/67 (0%)	0	0/1135 (0%)	0	0/1039 (0%)	0	1/766 (0.1%)	1	0/154 (0%)	0	0/375 (0%)	0
MELAENA	0/67 (0%)	0	0/1135 (0%)	0	0/1039 (0%)	0	1/766 (0.1%)	1	0/154 (0%)	0	0/375 (0%)	0
Infections and infestations
PNEUMONIA	0/67 (0%)	0	0/1135 (0%)	0	1/1039 (0.1%)	1	0/766 (0%)	0	0/154 (0%)	0	0/375 (0%)	0
PYELONEPHRITIS ACUTE	0/67 (0%)	0	0/1135 (0%)	0	1/1039 (0.1%)	1	1/766 (0.1%)	1	0/154 (0%)	0	0/375 (0%)	0
Injury, poisoning and procedural complications
EXTRADURAL HAEMATOMA	0/67 (0%)	0	0/1135 (0%)	0	0/1039 (0%)	0	1/766 (0.1%)	1	0/154 (0%)	0	0/375 (0%)	0
FEMUR FRACTURE	0/67 (0%)	0	0/1135 (0%)	0	0/1039 (0%)	0	1/766 (0.1%)	1	0/154 (0%)	0	0/375 (0%)	0
HUMERUS FRACTURE	0/67 (0%)	0	0/1135 (0%)	0	0/1039 (0%)	0	0/766 (0%)	0	1/154 (0.6%)	1	0/375 (0%)	0
Metabolism and nutrition disorders
DIABETES MELLITUS	0/67 (0%)	0	0/1135 (0%)	0	1/1039 (0.1%)	1	0/766 (0%)	0	0/154 (0%)	0	0/375 (0%)	0
HYPONATRAEMIA	0/67 (0%)	0	0/1135 (0%)	0	1/1039 (0.1%)	1	0/766 (0%)	0	0/154 (0%)	0	0/375 (0%)	0
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION	0/67 (0%)	0	0/1135 (0%)	0	1/1039 (0.1%)	1	0/766 (0%)	0	0/154 (0%)	0	0/375 (0%)	0
NEUROPATHIC ARTHROPATHY	0/67 (0%)	0	0/1135 (0%)	0	0/1039 (0%)	0	1/766 (0.1%)	1	0/154 (0%)	0	0/375 (0%)	0
PAIN IN EXTREMITY	0/67 (0%)	0	0/1135 (0%)	0	1/1039 (0.1%)	1	0/766 (0%)	0	0/154 (0%)	0	0/375 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATIC NEOPLASM MALIGNANT	0/67 (0%)	0	2/1135 (0.2%)	2	0/1039 (0%)	0	0/766 (0%)	0	0/154 (0%)	0	0/375 (0%)	0
PARATHYROID TUMOUR BENIGN	0/67 (0%)	0	0/1135 (0%)	0	0/1039 (0%)	0	1/766 (0.1%)	1	0/154 (0%)	0	0/375 (0%)	0
RECTAL CANCER	0/67 (0%)	0	0/1135 (0%)	0	1/1039 (0.1%)	1	0/766 (0%)	0	0/154 (0%)	0	0/375 (0%)	0
Nervous system disorders
CEREBRAL INFARCTION	0/67 (0%)	0	0/1135 (0%)	0	1/1039 (0.1%)	1	0/766 (0%)	0	0/154 (0%)	0	0/375 (0%)	0
DEMENTIA	0/67 (0%)	0	0/1135 (0%)	0	0/1039 (0%)	0	1/766 (0.1%)	1	0/154 (0%)	0	0/375 (0%)	0
DIZZINESS	0/67 (0%)	0	0/1135 (0%)	0	0/1039 (0%)	0	1/766 (0.1%)	1	0/154 (0%)	0	0/375 (0%)	0
NEUROLEPTIC MALIGNANT SYNDROME	0/67 (0%)	0	0/1135 (0%)	0	0/1039 (0%)	0	0/766 (0%)	0	1/154 (0.6%)	1	0/375 (0%)	0
QUADRIPLEGIA	0/67 (0%)	0	0/1135 (0%)	0	1/1039 (0.1%)	1	0/766 (0%)	0	0/154 (0%)	0	0/375 (0%)	0
Psychiatric disorders
ANXIETY	0/67 (0%)	0	0/1135 (0%)	0	1/1039 (0.1%)	1	0/766 (0%)	0	0/154 (0%)	0	0/375 (0%)	0
Renal and urinary disorders
RENAL FAILURE ACUTE	0/67 (0%)	0	0/1135 (0%)	0	0/1039 (0%)	0	0/766 (0%)	0	1/154 (0.6%)	1	0/375 (0%)	0
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM	0/67 (0%)	0	0/1135 (0%)	0	0/1039 (0%)	0	1/766 (0.1%)	1	0/154 (0%)	0	0/375 (0%)	0
VOCAL CORD POLYP	0/67 (0%)	0	0/1135 (0%)	0	1/1039 (0.1%)	1	0/766 (0%)	0	0/154 (0%)	0	0/375 (0%)	0
Vascular disorders
ANGIOPATHY	0/67 (0%)	0	0/1135 (0%)	0	1/1039 (0.1%)	1	0/766 (0%)	0	0/154 (0%)	0	0/375 (0%)	0
HYPERTENSION	0/67 (0%)	0	0/1135 (0%)	0	2/1039 (0.2%)	3	0/766 (0%)	0	0/154 (0%)	0	0/375 (0%)	0
Other (Not Including Serious) Adverse Events
	EZETROL Year 1		EZETROL Year 2		EZETROL Year 3		EZETROL Year 4		EZETROL Year 5		EZETROL Year 6
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/67 (0%)		5/1135 (0.4%)		3/1039 (0.3%)		0/766 (0%)		0/154 (0%)		29/375 (7.7%)
General disorders
FATIGUE	0/67 (0%)	0	5/1135 (0.4%)	5	3/1039 (0.3%)	3	0/766 (0%)	0	0/154 (0%)	0	29/375 (7.7%)	29

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.