Back to resultsEprotirome for the Treatment of Dyslipidemia, Efficacy and Safety 12-Week, Phase ii Study to Assess the Safety and Efficacy of KB2115 in Patients With Primary Hypercholesterolemia
Primary Purpose
Primary Hypercholesterolemia
Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Eprotirome
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Primary Hypercholesterolemia focused on measuring hypercholesterolemia, dyslipidemia, thyroid, safety
Eligibility Criteria
Inclusion Criteria:
- clinical diagnosis of hypercholesterolemia
Sites / Locations
- Jens Kristensen
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
1
Eprotirome dose 1
Eprotirome dose 2
Arm Description
Outcomes
Primary Outcome Measures
LDL cholesterol
Secondary Outcome Measures
Lipid variables, Thyroid hormone levels, Bone markers,DEXA, ECG, Echocardiography, liver enzymes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00776321
Brief Title
Eprotirome for the Treatment of Dyslipidemia, Efficacy and Safety 12-Week, Phase ii Study to Assess the Safety and Efficacy of KB2115 in Patients With Primary Hypercholesterolemia
Official Title
A Placebo Controlled, Double Blind, Randomised, 12-Week, Phase ii Study to Assess the Safety and Efficacy of KB2115 in Patients With Primary Hypercholesterolemia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (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 a clinical 2-weeks studies demonstrated pronounced reduction of 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 monotherapy following 12 weeks of exposure compared to placebo. The aim of the study is to assess efficacy (LDL-cholesterol lowering effects) and safety of KB2115.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hypercholesterolemia
Keywords
hypercholesterolemia, dyslipidemia, thyroid, safety
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
142 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Title
Eprotirome dose 1
Arm Type
Experimental
Arm Title
Eprotirome dose 2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Eprotirome
Other Intervention Name(s)
KB2115
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
LDL cholesterol
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Lipid variables, Thyroid hormone levels, Bone markers,DEXA, ECG, Echocardiography, liver enzymes
Time Frame
12 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
clinical diagnosis of hypercholesterolemia
Facility Information:
Facility Name
Jens Kristensen
City
Huddinge
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Eprotirome for the Treatment of Dyslipidemia, Efficacy and Safety 12-Week, Phase ii Study to Assess the Safety and Efficacy of KB2115 in Patients With Primary Hypercholesterolemia
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