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

NCT00677248 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2008-12-01

No results posted yet for this study

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 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.

Conditions

Interventions

DRUG

Ezetimibe and placebo

Placebo or three different doses of eprotirome added to ezetimibe treatment

DRUG

Eprotirome and ezetimibe

Placebo or three different doses of eprotirome added to ezetimibe treatment

Sponsors & Collaborators

  • Karo Bio AB

    lead INDUSTRY

Principal Investigators

  • Jens D Kristensen, MD, PhD · Karo Bio AB

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2008-09-30
Completion
2008-10-31

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00677248 on ClinicalTrials.gov