Back to resultsEfficacy and Safety Study of Eprotirome in HeFH Patients Who Are on Optimal Standard of Care (AKKA)
Primary Purpose
Heterozygous Familial Hypercholesterolaemia
Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Placebo
Eprotirome
Eprotirome
Sponsored by
About this trial
This is an interventional treatment trial for Heterozygous Familial Hypercholesterolaemia focused on measuring hypercholesterolemia,, dyslipidemia,, thyroid,, safety,, Heterozygous Familial Hypercholesterolaemia, coronary artery disease
Eligibility Criteria
Inclusion Criteria:
- Patients with confirmed HeFH and 18 years of age at screening
- Presence of clinical atherosclerotic disease that confers high risk for CAD events together with an LDL-C more than 2 mmol/L (more than 80 mg/dL)
- Presence of risk factors for CVD (other than the HeFH diagnosis) together with an LDL-C more than 2.5 mmol/L (more than 100 mg/dL)
- On an optimal standard of care, defined as being on a stable dose of statin (rosuvastatin, atorvastatin, or simvastatin) with or without ezetimibe for 8 weeks prior to randomisation
Exclusion Criteria:
- Significant health problems in recent past including heart failure,cardiac electrophysiologic instability, rheumatoid arthritis, thyroid dysfunction, liver disease, cancer, secondary dyslipidaemia
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
Eprotirome I
Eprotirome II
Arm Description
Outcomes
Primary Outcome Measures
Percent reduction in low-density lipoprotein cholesterol (LDL-C) from baseline
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01410383
Brief Title
Efficacy and Safety Study of Eprotirome in HeFH Patients Who Are on Optimal Standard of Care
Acronym
AKKA
Official Title
A Placebo-controlled, Double-blind, Randomised, Parallel-group, Long Term Phase III Trial Assessing the Safety and Efficacy of Eprotirome in Patients With Heterozygous Familial Hypercholesterolaemia Who Are on Optimal Standard of Care
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Terminated
Study Start Date
October 2011 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
October 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Karo Bio AB
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Eprotirome is a liver selective thyroid hormone that can reduce several independent risk factors for cardiovascular disease, while an euthyroid state is preserved in the extrahepatic tissue.
The purpose of this Phase III study is to assess the long-term efficacy and safety of Eprotirome in Patients with heterozygous Familial Hypercholesterolaemia who are on optimal standard of care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heterozygous Familial Hypercholesterolaemia
Keywords
hypercholesterolemia,, dyslipidemia,, thyroid,, safety,, Heterozygous Familial Hypercholesterolaemia, coronary artery disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
236 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Eprotirome I
Arm Type
Experimental
Arm Title
Eprotirome II
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablets taken daily
Intervention Type
Drug
Intervention Name(s)
Eprotirome
Other Intervention Name(s)
KB2115
Intervention Description
Tablets taken daily
Intervention Type
Drug
Intervention Name(s)
Eprotirome
Other Intervention Name(s)
KB2115
Intervention Description
Tablets taken daily
Primary Outcome Measure Information:
Title
Percent reduction in low-density lipoprotein cholesterol (LDL-C) from baseline
Time Frame
12 weeks treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with confirmed HeFH and 18 years of age at screening
Presence of clinical atherosclerotic disease that confers high risk for CAD events together with an LDL-C more than 2 mmol/L (more than 80 mg/dL)
Presence of risk factors for CVD (other than the HeFH diagnosis) together with an LDL-C more than 2.5 mmol/L (more than 100 mg/dL)
On an optimal standard of care, defined as being on a stable dose of statin (rosuvastatin, atorvastatin, or simvastatin) with or without ezetimibe for 8 weeks prior to randomisation
Exclusion Criteria:
Significant health problems in recent past including heart failure,cardiac electrophysiologic instability, rheumatoid arthritis, thyroid dysfunction, liver disease, cancer, secondary dyslipidaemia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Kastelein, Professor
Organizational Affiliation
Academic Medical Center (AMC) of the University of Amsterdam
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
24731671
Citation
Sjouke B, Langslet G, Ceska R, Nicholls SJ, Nissen SE, Ohlander M, Ladenson PW, Olsson AG, Hovingh GK, Kastelein JJ. Eprotirome in patients with familial hypercholesterolaemia (the AKKA trial): a randomised, double-blind, placebo-controlled phase 3 study. Lancet Diabetes Endocrinol. 2014 Jun;2(6):455-63. doi: 10.1016/S2213-8587(14)70006-3. Epub 2014 Feb 18.
Results Reference
derived
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Efficacy and Safety Study of Eprotirome in HeFH Patients Who Are on Optimal Standard of Care
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