LDL-Cholesterol Lowering Effect of KB2115 as Add on to Ezetimibe
NCT ID: NCT00677248
Last Updated: 2008-12-01
Study Results
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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COMPLETED
PHASE2
120 participants
INTERVENTIONAL
2008-04-30
2008-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Ezetimibe and placebo
Ezetimibe and placebo
Placebo or three different doses of eprotirome added to ezetimibe treatment
2
Eprotirome dose 1 and ezetimibe
Eprotirome and ezetimibe
Placebo or three different doses of eprotirome added to ezetimibe treatment
3
Eprotirome dose 2 and ezetimibe
Eprotirome and ezetimibe
Placebo or three different doses of eprotirome added to ezetimibe treatment
4
Eprotirome dose 3 and ezetimibe
Eprotirome and ezetimibe
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
Eprotirome and ezetimibe
Placebo or three different doses of eprotirome added to ezetimibe treatment
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Karo Bio AB
INDUSTRY
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
Countries
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Other Identifiers
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2007-007831-24
Identifier Type: -
Identifier Source: org_study_id
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