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Efficacy and Safety Study of Eprotirome in HeFH Patients Who Are on Optimal Standard of Care (AKKA)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Karo Bio AB
ClinicalTrials.gov Identifier:
NCT01410383
First received: July 13, 2011
Last updated: August 31, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Heterozygous Familial Hypercholesterolaemia
 Drug: Placebo
Drug: Eprotirome
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

Further study details as provided by Karo Bio AB:

Primary Outcome Measures:
  • Percent reduction in low-density lipoprotein cholesterol (LDL-C) from baseline [ Time Frame: 12 weeks treatment ] [ Designated as safety issue: No ]

Enrollment: 236
Study Start Date: October 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Tablets taken daily
Experimental: Eprotirome I Drug: Eprotirome
Tablets taken daily
Other Name: KB2115
Experimental: Eprotirome II Drug: Eprotirome
Tablets taken daily
Other Name: KB2115

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01410383

Sponsors and Collaborators
Karo Bio AB
Investigators
Principal Investigator: John Kastelein, Professor Academic Medical Center (AMC) of the University of Amsterdam
  More Information

No publications provided

Responsible Party: Karo Bio AB
ClinicalTrials.gov Identifier: NCT01410383     History of Changes
Other Study ID Numbers: KBT 009
Study First Received: July 13, 2011
Last Updated: August 31, 2012
Health Authority: Sweden: Regional Ethic committe

Keywords provided by Karo Bio AB:
hypercholesterolemia,
dyslipidemia,
thyroid,
 safety,
Heterozygous Familial Hypercholesterolaemia
coronary artery disease

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipoproteinemia Type II
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
 Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias

ClinicalTrials.gov processed this record on May 16, 2013