Effect of AMR101 (Ethyl Icosapentate) on Triglyceride (Tg... | NCT01047501

ID	Type	Description	Link
The ANCHOR Study	Other Identifier	Amarin Pharma Inc.

Status Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Placebo	Placebo Comparator	Drug: Placebo
AMR101 (ethyl icosapentate) - 2 g/day	Experimental	Drug: AMR101 (ethyl icosapentate) - 2 g/day
AMR101 (ethyl icosapentate) - 4 g/day	Experimental	Drug: AMR101 (ethyl icosapentate) - 4 g/day

Name	Type	Description	Arm Group Labels	Other Names
AMR101 (ethyl icosapentate) - 4 g/day	Drug	AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks	AMR101 (ethyl icosapentate) - 4 g/day

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect	Median percent change from baseline to Week 12 in fasting serum triglyceride levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day	baseline and 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Low-density Lipoprotein Cholesterol Levels	Median percent change from baseline to Week 12 in serum low density lipoprotein cholesterol levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day	baseline and 12 weeks

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
Amarin Investigational Site		Muscle Shoals	Alabama	35662	United States
Amarin Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22819432	Result	Ballantyne CM, Bays HE, Kastelein JJ, Stein E, Isaacsohn JL, Braeckman RA, Soni PN. Efficacy and safety of eicosapentaenoic acid ethyl ester (AMR101) therapy in statin-treated patients with persistent high triglycerides (from the ANCHOR study). Am J Cardiol. 2012 Oct 1;110(7):984-92. doi: 10.1016/j.amjcard.2012.05.031. Epub 2012 Jul 20.
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IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Placebo: Placebo 4 capsules/day for 12 weeks
FG001	AMR101 (Ethyl Icosapentate) - 2 g/Day	AMR101 (ethyl icosapentate) - 2 g/day: AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Placebo	Placebo: Placebo 4 capsules/day for 12 weeks
BG001	AMR101 (Ethyl Icosapentate) - 2 g/Day	AMR101 (ethyl icosapentate) - 2 g/day: AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks
BG002	AMR101 (Ethyl Icosapentate) - 4 g/Day	AMR101 (ethyl icosapentate) - 4 g/day: AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00061.2± 10.05 BG00161.8± 9.42 BG00261.1± 10.03 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00088 BG00192 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

White

Title	Measurements
	BG000224 BG001226 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Triglyceride Lowering Effect

Median percent change from baseline to Week 12 in fasting serum triglyceride levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day

Intent-to-treat population: randomized patients who received >= 1 dose of study drug and had baseline and >= 1 postrandomization efficacy measurement. Only patients with non-missing baseline and Week 12 endpoint values were included.

Posted

Median

Inter-Quartile Range

Percent change from baseline

baseline and 12 weeks

ID	Title	Description
OG000	AMR101 (Ethyl Icosapentate) - 2 g/Day	AMR101 (ethyl icosapentate) - 2 g/day: AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks
OG001	AMR101 (Ethyl Icosapentate) - 4 g/Day	AMR101 (ethyl icosapentate) - 4 g/day: AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks
OG002	Placebo	Placebo: Placebo 4 capsules/day for 12 weeks

Units	Counts
Participants	OG000234 OG001226 OG002227

Title

Denominators

Categories

Title	Measurements
	OG000-5.6(-21.1 to 13.4) OG001-17.5(-30.5 to 0.5) OG0025.9(-13.5 to 31.3)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG001 OG002	A sample size of 194 was required to provide 90.6% power to detect a difference of 15% between AMR101 4 g/day and placebo in percent change from baseline in fasting TG levels, assuming an SD of 45% in TG measurements and a significance level (p value) of 0.05, and 80% power to demonstrate noninferiority (p 0.025, 1-sided) of the LDL-cholesterol response between AMR101 4 g/day and placebo with a +6% margin. To accommodate a 10% drop-out rate, recruitment was planned for 648 randomized patients.	Wilcoxon rank-sum test	A prespecified step-down testing procedure was used to control Type I error rate using 4 g/day vs placebo then, if significant, 2 g/day vs placebo.	<0.0001	Nonparametric analysis p values were planned using Wilcoxon rank-sum test for each comparison between AMR101 and placebo. Comparisons between AMR101 and placebo were made using a significance level of 0.05.	Median Difference (Final Values)	-21.5			2-Sided	95	-26.7

Secondary

Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Low-density Lipoprotein Cholesterol Levels

Median percent change from baseline to Week 12 in serum low density lipoprotein cholesterol levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day

Posted

Median

Inter-Quartile Range

Percent change from baseline

baseline and 12 weeks

ID	Title	Description
OG000	AMR101 (Ethyl Icosapentate) - 2 g/Day	AMR101 (ethyl icosapentate) - 2 g/day: AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks
OG001	AMR101 (Ethyl Icosapentate) - 4 g/Day	AMR101 (ethyl icosapentate) - 4 g/day: AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks
OG002	Placebo	Placebo: Placebo 4 capsules/day for 12 weeks

Secondary

Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Non-High-Density Lipoprotein Cholesterol Levels

Median percent change from baseline to Week 12 in serum non-high density lipoprotein cholesterol levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day

Posted

Median

Inter-Quartile Range

Percent change from baseline

baseline and 12 weeks

ID	Title	Description
OG000	AMR101 (Ethyl Icosapentate) - 2 g/Day	AMR101 (ethyl icosapentate) - 2 g/day: AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks
OG001	AMR101 (Ethyl Icosapentate) - 4 g/Day	AMR101 (ethyl icosapentate) - 4 g/day: AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks
OG002	Placebo	Placebo: Placebo 4 capsules/day for 12 weeks

Secondary

Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Very Low-density Lipoprotein Cholesterol Levels

Median percent change from baseline to Week 12 in serum very low-density lipoprotein cholesterol levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day

Posted

Median

Inter-Quartile Range

Percent change from baseline

baseline and 12 weeks

ID	Title	Description
OG000	AMR101 (Ethyl Icosapentate) - 2 g/Day	AMR101 (ethyl icosapentate) - 2 g/day: AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks
OG001	AMR101 (Ethyl Icosapentate) - 4 g/Day	AMR101 (ethyl icosapentate) - 4 g/day: AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks
OG002	Placebo	Placebo: Placebo 4 capsules/day for 12 weeks

Secondary

Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Lipoprotein-associated Phospholipase A2 Levels

Median percent change from baseline to Week 12 in serum Lipoprotein-associated Phospholipase A2 levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day

Posted

Median

Inter-Quartile Range

Percent change from baseline

baseline and 12 weeks

ID	Title	Description
OG000	AMR101 (Ethyl Icosapentate) - 2 g/Day	AMR101 (ethyl icosapentate) - 2 g/day: AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks
OG001	AMR101 (Ethyl Icosapentate) - 4 g/Day	AMR101 (ethyl icosapentate) - 4 g/day: AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks
OG002	Placebo	Placebo: Placebo 4 capsules/day for 12 weeks

Secondary

Difference Between AMR101 (Ethyl Icosapentate) and Placebo Treatment Groups in Apolipoprotein B Levels

Median percent change from baseline to Week 12 in serum Apolipoprotein B levels following treatment with AMR101 (ethyl icosapentate) 2 g/day or 4 g/day

Posted

Median

Inter-Quartile Range

Percent change from baseline

baseline and 12 weeks

ID	Title	Description
OG000	AMR101 (Ethyl Icosapentate) - 2 g/Day	AMR101 (ethyl icosapentate) - 2 g/day: AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks
OG001	AMR101 (Ethyl Icosapentate) - 4 g/Day	AMR101 (ethyl icosapentate) - 4 g/day: AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks
OG002	Placebo	Placebo: Placebo 4 capsules/day for 12 weeks

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Placebo: Placebo 4 capsules/day for 12 weeks	5	233	25	233
EG001	AMR101 (Ethyl Icosapentate) - 2 g/Day	AMR101 (ethyl icosapentate) - 2 g/day: AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks	6	236	28	236
EG002	AMR101 (Ethyl Icosapentate) - 4 g/Day	AMR101 (ethyl icosapentate) - 4 g/day: AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks	7	233	18	233

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Coronary artery disease	Cardiac disorders	MedDRA (13.0)	Systematic Assessment	EG0001 affected233 at risk EG0011 affected236 at risk EG0020 affected233 at risk
Myocardial infarction	Cardiac disorders	MedDRA (13.0)	Systematic Assessment	EG0002 affected233 at risk EG0010 affected236 at risk EG0020 affected233 at risk
Angina, unstable	Cardiac disorders	MedDRA (13.0)	Systematic Assessment	EG0000 affected233 at risk EG0011 affected236 at risk EG0020 affected233 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA (13.0)	Systematic Assessment	EG0000 affected233 at risk EG0010 affected236 at risk EG0021 affected233 at risk
Bradycardia	Cardiac disorders	MedDRA (13.0)	Systematic Assessment	EG0001 affected233 at risk EG0010 affected236 at risk EG0020 affected233 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG0000 affected233 at risk EG0011 affected236 at risk EG0020 affected233 at risk
Non-cardiac chest pain	General disorders	MedDRA (13.0)	Systematic Assessment	EG0000 affected233 at risk EG0012 affected236 at risk EG0022 affected233 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0001 affected233 at risk EG0010 affected236 at risk EG0020 affected233 at risk
Herpes zoster	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0000 affected233 at risk EG0010 affected236 at risk EG0021 affected233 at risk
Subdural hematoma	Injury, poisoning and procedural complications	MedDRA (13.0)	Systematic Assessment	EG0000 affected233 at risk EG0011 affected236 at risk EG0020 affected233 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA (13.0)	Systematic Assessment	EG0001 affected233 at risk EG0010 affected236 at risk EG0020 affected233 at risk
Breast cancer in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (13.0)	Systematic Assessment	EG0000 affected233 at risk EG0011 affected236 at risk EG0020 affected233 at risk
Multiple myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (13.0)	Systematic Assessment	EG0001 affected233 at risk EG0010 affected236 at risk EG0020 affected233 at risk
Subarachnoid hemorrhage	Nervous system disorders	MedDRA (13.0)	Systematic Assessment	EG0000 affected233 at risk EG0011 affected236 at risk EG0021 affected233 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA (13.0)	Systematic Assessment	EG0001 affected233 at risk EG0010 affected236 at risk EG0020 affected233 at risk
Presyncope	Nervous system disorders	MedDRA (13.0)	Systematic Assessment	EG0000 affected233 at risk EG0010 affected236 at risk EG0021 affected233 at risk
Ruptured cerebral aneurysm	Nervous system disorders	MedDRA (13.0)	Systematic Assessment	EG0000 affected233 at risk EG0010 affected236 at risk EG0021 affected233 at risk
Syncope	Nervous system disorders	MedDRA (13.0)	Systematic Assessment	EG0000 affected233 at risk EG0011 affected236 at risk EG0020 affected233 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Systematic Assessment	EG0000 affected233 at risk EG0010 affected236 at risk EG0021 affected233 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhea	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG00010 affected233 at risk EG0019 affected236 at risk EG0028 affected233 at risk
Nasopharyngitis	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0007 affected233 at risk EG0016 affected236 at risk EG0021 affected233 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (13.0)	Systematic Assessment	EG0001 affected233 at risk EG0018 affected236 at risk EG0024 affected233 at risk
Nausea	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG0007 affected233 at risk EG0015 affected236 at risk EG0025 affected233 at risk

ID	Term
D015228	Hypertriglyceridemia
D050171	Dyslipidemias

ID	Term
D006949	Hyperlipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
C035276	eicosapentaenoic acid ethyl ester
C509895	eicosapentaenoic acid ethanolamide