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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

NCT ID: NCT00776321

Last Updated: 2008-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Primary Hypercholesterolemia

Keywords

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hypercholesterolemia dyslipidemia thyroid safety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Study Groups

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1

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Eprotirome dose 1

Group Type EXPERIMENTAL

Eprotirome

Intervention Type DRUG

Eprotirome dose 2

Group Type EXPERIMENTAL

Eprotirome

Intervention Type DRUG

Interventions

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Eprotirome

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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KB2115

Eligibility Criteria

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Inclusion Criteria

* clinical diagnosis of hypercholesterolemia
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karo Bio AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Karo Bio AB

Locations

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Jens Kristensen

Huddinge, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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EudraCT No: 2006-003191-35

Identifier Type: -

Identifier Source: org_study_id