Trial | NCT00776321  Report issue

Title

Eprotirome for the Treatment of Dyslipidemia, Efficacy and Safety 12-Week, Phase ii Study to Assess the Safety and Efficacy of KB2115 in Patients With Primary Hypercholesterolemia
A Placebo Controlled, Double Blind, Randomised, 12-Week, Phase ii Study to Assess the Safety and Efficacy of KB2115 in Patients With Primary Hypercholesterolemia

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    eprotirome ...

  • Study Participants

    142
Eprotirome (KB2115) is a liver selective thyroid hormone that can induce hyperthyroidism in the liver, while an euthyroid state is preserved in the extrahepatic tissue. Eprotirome has in a clinical 2-weeks studies demonstrated pronounced reduction of independent risk factors for the development of atherosclerotic cardiovascular diseases.

The purpose of the study is to assess the efficacy and safety of KB2115 as monotherapy following 12 weeks of exposure compared to placebo. The aim of the study is to assess efficacy (LDL-cholesterol lowering effects) and safety of KB2115.
Study Started
Sep 30
2006
Primary Completion
Oct 31
2007
Study Completion
Oct 31
2007
Last Update
Oct 21
2008
Estimate

Drug Eprotirome

  • Other names: KB2115

Drug Placebo

1 Placebo Comparator

Eprotirome dose 1 Experimental

Eprotirome dose 2 Experimental

Criteria 

Inclusion Criteria:

clinical diagnosis of hypercholesterolemia
No Results Posted