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

Heterozygous Familial Hypercholesterolaemia Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01410383
• Other study ID #: KBT 009
• Status: Terminated
• Phase: Phase 3
• First received: July 13, 2011
• Last updated: August 31, 2012
• Start date: October 2011
• Est. completion date: October 2014

Study information

• Verified date: August 2012
• Source: Karo Bio AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethic committe
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 236
• Est. completion date: October 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Heterozygous Familial Hypercholesterolaemia
• Hypercholesterolemia
• Hyperlipoproteinemia Type II

Intervention

Drug:
• Placebo
Tablets taken daily
• Eprotirome
Tablets taken daily
• Eprotirome
Tablets taken daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Karo Bio AB

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent reduction in low-density lipoprotein cholesterol (LDL-C) from baseline		12 weeks treatment	No