A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and on Statin

Phase 3

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Drug: Placebo; Drug: AMR101; Drug: Statin therapy

• Registration Number: NCT01492361
• Lead Sponsor: Amarin Pharma Inc.

Brief Summary

AMR101 (icosapent ethyl \[ethyl-EPA\]) is a highly purified ethyl ester of eicosapentaenoic acid (EPA) developed by Amarin Pharma Inc. for the treatment of cardiovascular disease in statin-treated patients with hypertriglyceridemia. The purpose of this study was to evaluate whether this drug, combined with a statin therapy, will be superior to the statin therapy alone, when used as a prevention in reducing long-term cardiovascular events in high-risk patients with mixed dyslipidemia.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-12-13
• Study First Submitted QC: 2011-12-13
• Study First Posted: 2011-12-15
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Disposition First Submitted: 2019-06-04
• Disposition First Submitted QC: 2019-06-04
• Disposition First Posted: 2019-06-06
• Results First Submitted: 2022-02-08
• Status Verified: 2022-03
• Results First Submitted QC: 2022-03-21
• Last Update Submitted: 2022-03-21
• Results First Posted: 2022-04-14
• Last Update Posted: 2022-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8179

Inclusion Criteria

• Men and non-pregnant or sterile women ages 45 and older
• Hypertriglyceridemia
• On statin therapy for at least four weeks
• Either having established cardiovascular disease or at high risk for cardiovascular disease

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Exclusion Criteria

• Severe heart failure

• Any life-threatening disease other than cardiovascular disease

• Active severe liver disease

• Hemoglobin A1c >10.0%

• Poorly controlled hypertension

• Planned coronary intervention (such as stent placement or heart bypass) or any non-cardiac major surgical procedure

• Known familial lipoprotein lipase deficiency (Fredrickson Type I), apolipoprotein C-II deficiency, or familial dysbetalipoproteinemia (Fredrickson Type III)

• Known hypersensitivity to the study product, fish and/or shellfish, or placebo

• History of acute or chronic pancreatitis

• Patients are excluded if using the following medications:

  • PCSK9 inhibitors
  • niacin >200 mg/day or fibrates;
  • any omega-3 fatty acid medications ;
  • dietary supplements containing omega-3 fatty acids (e.g., flaxseed oil, fish oil, krill oil, or algal oil);
  • bile acid sequestrants

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo + statin therapy, daily
AMR101	AMR101	AMR101 (icosapent ethyl) + statin therapy, daily
Placebo	Statin therapy	Placebo + statin therapy, daily
AMR101	Statin therapy	AMR101 (icosapent ethyl) + statin therapy, daily

Primary Outcome Measures

Name	Time	Method
Composite of CV Death, Nonfatal MI (Including Silent MI), Nonfatal Stroke, Coronary Revascularization, or Unstable Angina Determined to be Caused by Myocardial Ischemia by Invasive / Non-invasive Testing and Requiring Emergent Hospitalization.	Total follow-up time of up to approximately 6 years.	The primary outcome measure was the number of patients with a first occurrence of any component of the composite of CV death, nonfatal MI (including silent MI), nonfatal stroke, coronary revascularization, or unstable angina determined to be caused by myocardial ischemia by invasive / non-invasive testing and requiring emergent hospitalization during the follow-up period.

Secondary Outcome Measures

Name	Time	Method
Total Mortality, Nonfatal MI (Including Silent MI), or Nonfatal Stroke.	Total follow-up time of up to approximately 6 years.	Number of patients with a first occurrence of any component of the composite of total mortality, nonfatal MI (including silent MI), or nonfatal stroke during the follow-up period.
Composite of CV Death, Nonfatal MI (Including Silent MI), or Nonfatal Stroke.	Total follow-up time of up to approximately 6 years.	The key secondary outcome measure was the number of patients with a first occurrence of any component of the composite of CV death, nonfatal MI (including silent MI), or nonfatal stroke during the follow-up period.
CV Death.	Total follow-up time of up to approximately 6 years.	Number of patients with an occurrence of CV death during the follow-up period.
Fatal or Nonfatal Stroke.	Total follow-up time of up to approximately 6 years.	Number of patients with a first occurrence of fatal or nonfatal stroke during the follow-up period.
Unstable Angina Determined to be Caused by Myocardial Ischemia by Invasive / Non-invasive Testing and Requiring Emergent Hospitalization.	Total follow-up time of up to approximately 6 years.	Number of patients with a first occurrence of unstable angina determined to be caused by myocardial ischemia by invasive / non-invasive testing and requiring emergent hospitalization during the follow-up period.
Fatal or Nonfatal MI (Including Silent MI).	Total follow-up time of up to approximately 6 years.	Number of patients with a first occurrence of fatal or nonfatal MI (including silent MI) during the follow-up period.
Total Mortality.	Total follow-up time of up to approximately 6 years.	Number of patients with an occurrence of death from any cause during the follow-up period.
Composite of CV Death or Nonfatal MI (Including Silent MI).	Total follow-up time of up to approximately 6 years.	Number of patients with a first occurrence of any component of the composite of CV death or nonfatal MI (including silent MI) during the follow-up period.
Non-elective Coronary Revascularization Represented as the Composite of Emergent or Urgent Classifications.	Total follow-up time of up to approximately 6 years.	Number of patients with a first occurrence of non-elective coronary revascularization represented as the composite of emergent or urgent classifications during the follow-up period.

Trial Locations

Locations (1)

Amarin Investigational Site; 🇺🇦 Zaporizhzhia, Ukraine