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
Sponsor study identifier
interventional
120
1 country
1
Study Start
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2008
Actual (reported)Study Completion
October 2008
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2008
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
May 12, 2008
Actual (reported)May 14, 2008
Actual (reported)September 2008
Actual (reported)October 2008
Actual (reported)LDL cholesterol
10 weeks
Triglycerides
10 weeks
Ezetimibe and placebo
Eprotirome dose 1 and ezetimibe
Eprotirome dose 2 and ezetimibe
Placebo or three different doses of eprotirome added to ezetimibe treatment
Placebo or three different doses of eprotirome added to ezetimibe treatment
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Eprotirome and ezetimibe
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordKaro Bio AB
Huddinge, Sweden
Jens D Kristensen, MD, PhD
Karo Bio AB
First Submitted
May 12, 2008
First Posted
May 14, 2008
Study Start
April 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2008
Actual (reported)Eprotirome dose 3 and ezetimibe
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Study Completion
October 2008
Actual (reported)Last Updated
December 1, 2008
Record last verified: 2008-05
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Source: ClinicalTrials.gov.
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