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

NCT01410383 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2012-09-03

No results posted yet for this study

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

DRUG

Placebo

Tablets taken daily

DRUG

Eprotirome

Tablets taken daily

DRUG

Eprotirome

Tablets taken daily

Sponsors & Collaborators

  • Karo Bio AB

    lead INDUSTRY

Principal Investigators

  • John Kastelein, Professor · Academic Medical Center (AMC) of the University of Amsterdam

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-10-31
Completion
2014-10-31

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01410383 on ClinicalTrials.gov