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LDL-Cholesterol Lowering Effect of KB2115 as Add on to Ezetimibe

NCT ID: NCT00677248

Last Updated: 2008-12-01

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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2008-10-31

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 clinical trials demonstrated pronounced reduction of several 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 add on therapy to ezetimibe following 10 weeks of exposure compared to placebo. The aim of the study is to assess efficacy (LDL-cholesterol lowering effects) and safety of KB2115 and to define a clinically relevant dose or dose range for future studies.

Detailed Description

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Conditions

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Hypercholesterolemia

Keywords

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Eprotirome KB2115 dyslipidemia hypercholesterolemia hypertriglyceridemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Ezetimibe and placebo

Group Type PLACEBO_COMPARATOR

Ezetimibe and placebo

Intervention Type DRUG

Placebo or three different doses of eprotirome added to ezetimibe treatment

2

Eprotirome dose 1 and ezetimibe

Group Type EXPERIMENTAL

Eprotirome and ezetimibe

Intervention Type DRUG

Placebo or three different doses of eprotirome added to ezetimibe treatment

3

Eprotirome dose 2 and ezetimibe

Group Type EXPERIMENTAL

Eprotirome and ezetimibe

Intervention Type DRUG

Placebo or three different doses of eprotirome added to ezetimibe treatment

4

Eprotirome dose 3 and ezetimibe

Group Type EXPERIMENTAL

Eprotirome and ezetimibe

Intervention Type DRUG

Placebo or three different doses of eprotirome added to ezetimibe treatment

Interventions

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Ezetimibe and placebo

Placebo or three different doses of eprotirome added to ezetimibe treatment

Intervention Type DRUG

Eprotirome and ezetimibe

Placebo or three different doses of eprotirome added to ezetimibe treatment

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males or females aged 18 to 75 years
* Patient with primary hypercholesterolemia with an LDL-cholesterol \> 3.0 mmol/L
* At randomization, diet as instructed by the investigator during the last 4 weeks prior to randomization and willingness to follow these instructions throughout the study

Exclusion Criteria

* History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 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

Principal Investigators

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Jens D Kristensen, MD, PhD

Role: STUDY_CHAIR

Karo Bio AB

Locations

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Karo Bio AB

Huddinge, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2007-007831-24

Identifier Type: -

Identifier Source: org_study_id