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

November 27, 2008 updated by: Karo Bio AB

A Phase II, Placebo-Controlled, Double-Blind, Randomised, 10-Week, Parallel-Group Study to Assess the Efficacy of Different Doses of KB2115 as Add on to Ezetimibe Treatment in Patients With Primary Hypercholesterolemia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • HUddinge, Sweden
        • Karo Bio AB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Ezetimibe and placebo
Drug: Ezetimibe and placebo
Placebo or three different doses of eprotirome added to ezetimibe treatment
Experimental: 2
Eprotirome dose 1 and ezetimibe
Drug: Eprotirome and ezetimibe
Placebo or three different doses of eprotirome added to ezetimibe treatment
Experimental: 3
Eprotirome dose 2 and ezetimibe
Drug: Eprotirome and ezetimibe
Placebo or three different doses of eprotirome added to ezetimibe treatment
Experimental: 4
Eprotirome dose 3 and ezetimibe
Drug: Eprotirome and ezetimibe
Placebo or three different doses of eprotirome added to ezetimibe treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
LDL cholesterol
Time Frame: 10 weeks
10 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Triglycerides
Time Frame: 10 weeks
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karo Bio AB

Investigators

  • Study Chair: Jens D Kristensen, MD, PhD, Karo Bio AB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

May 12, 2008

First Submitted That Met QC Criteria

May 13, 2008

First Posted (Estimate)

May 14, 2008

Study Record Updates

Last Update Posted (Estimate)

December 1, 2008

Last Update Submitted That Met QC Criteria

November 27, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-007831-24

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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