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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

This study has been completed.
Sponsor:
Information provided by:
Karo Bio AB
ClinicalTrials.gov Identifier:
NCT00776321
First received: October 17, 2008
Last updated: October 20, 2008
Last verified: October 2008
History of Changes
  Purpose

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 Intervention Phase
Primary Hypercholesterolemia
 Drug: Eprotirome
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Karo Bio AB:

Primary Outcome Measures:
  • LDL cholesterol [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lipid variables, Thyroid hormone levels, Bone markers,DEXA, ECG, Echocardiography, liver enzymes [ Time Frame: 12 week ] [ Designated as safety issue: Yes ]

Enrollment: 142
Study Start Date: September 2006
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: Placebo
Experimental: Eprotirome dose 1 Drug: Eprotirome
Other Name: KB2115
Experimental: Eprotirome dose 2 Drug: Eprotirome
Other Name: KB2115

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • clinical diagnosis of hypercholesterolemia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00776321

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

No publications provided

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
Study First Received: October 17, 2008
Last Updated: October 20, 2008
Health Authority: Sweden: Medical Products Agency

Keywords provided by Karo Bio AB:
hypercholesterolemia
dyslipidemia
thyroid
safety

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

ClinicalTrials.gov processed this record on May 19, 2013