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

This study has been completed.
Sponsor:
Information provided by:
Karo Bio AB
ClinicalTrials.gov Identifier:
NCT00677248
First received: May 12, 2008
Last updated: November 27, 2008
Last verified: May 2008
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Ezetimibe
Anticholesteremic Agents
Antimetabolites
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014