LDL-Cholesterol Lowering Effect of KB2115 as Add on to Ezetimibe
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
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2008
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 12, 2008
CompletedFirst Posted
Study publicly available on registry
May 14, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedDecember 1, 2008
May 1, 2008
5 months
May 12, 2008
November 27, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
LDL cholesterol
10 weeks
Secondary Outcomes (1)
Triglycerides
10 weeks
Study Arms (4)
1
PLACEBO COMPARATOREzetimibe and placebo
2
EXPERIMENTALEprotirome dose 1 and ezetimibe
3
EXPERIMENTALEprotirome dose 2 and ezetimibe
4
EXPERIMENTALEprotirome dose 3 and ezetimibe
Interventions
Placebo or three different doses of eprotirome added to ezetimibe treatment
Placebo or three different doses of eprotirome added to ezetimibe treatment
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karo Bio ABlead
Study Sites (1)
Karo Bio AB
Huddinge, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jens D Kristensen, MD, PhD
Karo Bio AB
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 12, 2008
First Posted
May 14, 2008
Study Start
April 1, 2008
Primary Completion
September 1, 2008
Study Completion
October 1, 2008
Last Updated
December 1, 2008
Record last verified: 2008-05