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

• Conditions: Hypercholesterolemia; MedDRA version: 9.1Level: LLTClassification code 10020603Term: Hypercholesterolaemia

• Registration Number: EUCTR2007-007831-24-SE
• Lead Sponsor: Karo Bio AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-24
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Signed informed consent

Males or females aged > 18 to <75 years. Female patients must be non-fertile. To be considered as non-fertile, females must fulfill the following:
Non-nursing and non-pregnant 12 months prior to enrolment
Not of child bearing potential i.e., either documented irreversible surgically sterile (bilateral oophorectomy or hysterectomy is acceptable, but not tubal ligation) or post-menopausal. Post-menopausal is defined as serum follicle-stimulating hormone levels in the post-menopausal range combined with amenorrhea for more than 1 year in a woman above 50 years of age, or amenorrhea for more than 2 years below 50 years of age

Patient with hypercholesterolemia with an LDL-cholesterol > 3.0 mmol/L at Enrolment and Visit Week –1.

Patient able and willing to comply with all study requirements

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Cholesterol lowering agents other than ezetimibe

History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study as judged by the investigator

Clinically significant illness or clinically relevant trauma within 2 weeks before the administration of the investigational product as judged by the investigator

Chronic (> 3 months) pain condition requiring daily medication with pain killers

Glycosylated hemoglobin (HbA1c) > 7.5% at week -1

Diabetes requiring medication other than metformin

Cholestyramine, anticoagulants (eg. Warfarin) or cyclosporine (due to ezetimibe interactions).

Clinically abnormal physical findings and laboratory values as judged by the investigator and abnormal resting electrocardiogram (ECG), eg, QTc interval > 500 msec at enrolment or week -1

Body Mass Index of = 40 kg/m2

Resent history (< 3 month) of stroke or transient ischemic attacks

History of seizure disorder, except febrile convulsions

A current diagnosis of cancer, unless in remission

BP of > 160/95 mm Hg at baseline

History of cardiac arrhythmia, such as intermittent supraventricular tachyarrhythmia and atrial fibrillation

Unstable angina pectoris, myocardial infarction or coronary bypass graft surgery or percutaneous coronary intervention < 6 month before randomization
Patients with ongoing statin treatment and previous myocardial infarction or coronary bypass graft surgery or percutaneous coronary intervention, regardless of time elapsed, are to be excluded from this study

Congestive heart failure New York Heart Association Class > 2

Unstable or severe angina pectoris or peripheral artery disease

Known thyroid disease or thyroid biomarkers (thyroid-stimulating hormone [TSH], T3, free T3, T4, free T4) outside reference range for normal at enrolment and week -1

Positive urine pregnancy test in women at enrolment

Use of thyroid replacement therapy and hormone replacement therapy (including contraceptive pills) for last 3 months before randomization

Positive test for human immunodeficiency virus (HIV), hepatitis B or C at week -1

Known impairment of liver function or known liver disease, such as hepatitis or liver cirrhosis

Bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase or -glutamyl transpeptidase > 1.5-fold ULN at Enrollment (Screening Visit) or Visit Week 1

History of (past 2 years) or present alcohol or drug abuse as judged by the investigator or patients who consume > 14 alcoholic drinks per week.

Involvement in the planning and conduct of the study (applies to both Karo Bio AB staff and clinical research organizations)

Participation in a clinical study during the past 30 days anticipated to interfere with the objectives of the study as judged by the investigator

Previous randomization of treatment in present study or previous treatment with KB2115

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified