Trial record 67 of 153 for:    "familial hypercholesterolemia"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01410383
Recruitment Status : Terminated
First Posted : August 5, 2011
Last Update Posted : September 3, 2012
Information provided by (Responsible Party):
Karo Bio AB

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.

Condition or disease Intervention/treatment Phase
Heterozygous Familial Hypercholesterolaemia Drug: Placebo Drug: Eprotirome Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 236 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : October 2011
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Percent reduction in low-density lipoprotein cholesterol (LDL-C) from baseline [ Time Frame: 12 weeks treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01410383

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Karo Bio AB Identifier: NCT01410383     History of Changes
Other Study ID Numbers: KBT 009
First Posted: August 5, 2011    Key Record Dates
Last Update Posted: September 3, 2012
Last Verified: August 2012

Keywords provided by Karo Bio AB:
Heterozygous Familial Hypercholesterolaemia
coronary artery disease

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