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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

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ClinicalTrials.gov Identifier: NCT00776321
Recruitment Status : Completed
First Posted : October 21, 2008
Last Update Posted : October 21, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Primary Hypercholesterolemia Drug: Eprotirome Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Placebo Controlled, Double Blind, Randomised, 12-Week, Phase ii Study to Assess the Safety and Efficacy of KB2115 in Patients With Primary Hypercholesterolemia
Study Start Date : September 2006
Primary Completion Date : October 2007
Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: 1 Drug: Placebo
Experimental: Eprotirome dose 1 Drug: Eprotirome
Other Name: KB2115
Experimental: Eprotirome dose 2 Drug: Eprotirome
Other Name: KB2115


Outcome Measures

Primary Outcome Measures :
  1. LDL cholesterol [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  1. Lipid variables, Thyroid hormone levels, Bone markers,DEXA, ECG, Echocardiography, liver enzymes [ Time Frame: 12 week ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • clinical diagnosis of hypercholesterolemia
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00776321


Locations
Sweden
Jens Kristensen
Huddinge, Sweden
Sponsors and Collaborators
Karo Bio AB
More Information

Responsible Party: Jens Kristensen, MD PhD, Chief Medical Officer, Karo Bio AB
ClinicalTrials.gov Identifier: NCT00776321     History of Changes
Other Study ID Numbers: EudraCT No: 2006-003191-35
First Posted: October 21, 2008    Key Record Dates
Last Update Posted: October 21, 2008
Last Verified: October 2008

Keywords provided by Karo Bio AB:
hypercholesterolemia
dyslipidemia
thyroid
safety

Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases