Back to resultsLDL-Cholesterol Lowering Effect of KB2115 as Add on to Ezetimibe
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Ezetimibe and placebo
Eprotirome and ezetimibe
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia focused on measuring Eprotirome, KB2115, dyslipidemia, hypercholesterolemia, hypertriglyceridemia
Eligibility Criteria
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
Sites / Locations
- Karo Bio AB
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
1
2
3
4
Arm Description
Ezetimibe and placebo
Eprotirome dose 1 and ezetimibe
Eprotirome dose 2 and ezetimibe
Eprotirome dose 3 and ezetimibe
Outcomes
Primary Outcome Measures
LDL cholesterol
Secondary Outcome Measures
Triglycerides
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00677248
Brief Title
LDL-Cholesterol Lowering Effect of KB2115 as Add on to Ezetimibe
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Karo Bio AB
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
Eprotirome, KB2115, dyslipidemia, hypercholesterolemia, hypertriglyceridemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Ezetimibe and placebo
Arm Title
2
Arm Type
Experimental
Arm Description
Eprotirome dose 1 and ezetimibe
Arm Title
3
Arm Type
Experimental
Arm Description
Eprotirome dose 2 and ezetimibe
Arm Title
4
Arm Type
Experimental
Arm Description
Eprotirome dose 3 and ezetimibe
Intervention Type
Drug
Intervention Name(s)
Ezetimibe and placebo
Intervention Description
Placebo or three different doses of eprotirome added to ezetimibe treatment
Intervention Type
Drug
Intervention Name(s)
Eprotirome and ezetimibe
Intervention Description
Placebo or three different doses of eprotirome added to ezetimibe treatment
Primary Outcome Measure Information:
Title
LDL cholesterol
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Triglycerides
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens D Kristensen, MD, PhD
Organizational Affiliation
Karo Bio AB
Official's Role
Study Chair
Facility Information:
Facility Name
Karo Bio AB
City
HUddinge
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
LDL-Cholesterol Lowering Effect of KB2115 as Add on to Ezetimibe
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