Status:
TERMINATED
Efficacy and Safety Study of Eprotirome in HeFH Patients Who Are on Optimal Standard of Care
Lead Sponsor:
Karo Bio AB
Conditions:
Heterozygous Familial Hypercholesterolaemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 purp...
Eligibility Criteria
Inclusion
- 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
- Significant health problems in recent past including heart failure,cardiac electrophysiologic instability, rheumatoid arthritis, thyroid dysfunction, liver disease, cancer, secondary dyslipidaemia
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
236 Patients enrolled
Trial Details
Trial ID
NCT01410383
Start Date
October 1 2011
End Date
October 1 2014
Last Update
September 3 2012
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