NCT01410383

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 236 (actual)
• Sponsor: Karo Bio AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heterozygous Familial Hypercholesterolaemia

Interventions

Type	Name	Description
DRUG	Placebo	Tablets taken daily
DRUG	Eprotirome	Tablets taken daily
DRUG	Eprotirome	Tablets taken daily

Timeline

• Start date: 2011-10-01
• Primary completion: 2013-10-01
• Completion: 2014-10-01
• First posted: 2011-08-05
• Last updated: 2012-09-03