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

Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00677248
• Other study ID #: 2007-007831-24
• Status: Completed
• Phase: Phase 2
• First received: May 12, 2008
• Last updated: November 27, 2008
• Start date: April 2008
• Est. completion date: October 2008

Study information

• Verified date: May 2008
• Source: Karo Bio AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• Ezetimibe and placebo
Placebo or three different doses of eprotirome added to ezetimibe treatment
• Eprotirome and ezetimibe
Placebo or three different doses of eprotirome added to ezetimibe treatment

Locations

Country	Name	City	State
Sweden	Karo Bio AB	HUddinge

Sponsors (1)

Lead Sponsor	Collaborator
Karo Bio AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL cholesterol		10 weeks	No
Secondary	Triglycerides		10 weeks	No