LDL-Cholesterol Lowering Effect of KB2115 as Add on to Ezetimibe - Full Text View

Purpose

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.

Condition	Intervention	Phase
Hypercholesterolemia	Drug: Ezetimibe and placebo Drug: Eprotirome and ezetimibe	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol

Drug Information available for: Ezetimibe

U.S. FDA Resources

Further study details as provided by Karo Bio AB:

Primary Outcome Measures:

LDL cholesterol [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Triglycerides [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	April 2008
Study Completion Date:	October 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1 Ezetimibe and placebo	Drug: Ezetimibe and placebo Placebo or three different doses of eprotirome added to ezetimibe treatment
Experimental: 2 Eprotirome dose 1 and ezetimibe	Drug: Eprotirome and ezetimibe Placebo or three different doses of eprotirome added to ezetimibe treatment
Experimental: 3 Eprotirome dose 2 and ezetimibe	Drug: Eprotirome and ezetimibe Placebo or three different doses of eprotirome added to ezetimibe treatment
Experimental: 4 Eprotirome dose 3 and ezetimibe	Drug: Eprotirome and ezetimibe Placebo or three different doses of eprotirome added to ezetimibe treatment

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00677248

Locations

Sweden
Karo Bio AB
HUddinge, Sweden

Sponsors and Collaborators

Karo Bio AB

Investigators

Study Chair:

Jens D Kristensen, MD, PhD

Karo Bio AB

More Information

No publications provided

Responsible Party:	Chief Medical Officer, Karo Bio AB
ClinicalTrials.gov Identifier:	NCT00677248 History of Changes
Other Study ID Numbers:	2007-007831-24
Study First Received:	May 12, 2008
Last Updated:	November 27, 2008
Health Authority:	Sweden: Medical Products Agency

Keywords provided by Karo Bio AB:

Eprotirome
KB2115
dyslipidemia
hypercholesterolemia
hypertriglyceridemia

Additional relevant MeSH terms:

Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Ezetimibe
Anticholesteremic Agents

Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013