LDL-Cholesterol Lowering Effect of KB2115 as Add on to Ezetimibe
Information source: Karo Bio AB
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypercholesterolemia
Intervention: Ezetimibe and placebo (Drug); Eprotirome and ezetimibe (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Karo Bio AB Official(s) and/or principal investigator(s):
Jens D Kristensen, MD, PhD, Study Chair, Affiliation: Karo Bio AB
Overall contact:
Jens D Kristensen, MD, PhD, Phone: 46-8608-6005, Email: Jens.kristensen@karobio.se
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.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: LDL cholesterol
Secondary outcome: Triglycerides
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Jens D Kristensen, MD, PhD, Phone: 46-8608-6005, Email: Jens.kristensen@karobio.se
Karo Bio AB, HUddinge, Sweden; Recruiting
Carl-Peter Anderberg, MD, Principal Investigator
Additional Information
Starting date: April 2008
Last updated: May 13, 2008
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