A Phase II, Placebo-Controlled, Double-Blind, Randomised, 12-Week, Parallel-group Study to Assess the Efficacy of Different Doses of KB 2115 as add on to Statin Treatment in Patients With Dyslipidemia

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

• Registration Number: EUCTR2007-004413-33-FI
• Lead Sponsor: Karo Bio AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-24
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1. Signed informed consent
2. Males or females aged 18 to 75 years. Female patients must be non-fertile. To be considered as non-fertile, females must fulfil the following:
a. Non-nursing and non-pregnant 12 months prior to enrolment
b. Not of child bearing potential ie, 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
3. Patients with hypercholesterolemia treated with stable doses of the below listed lipid lowering medication for at least 3 months prior to randomization
a. Atorvastatin not more than 20 mg/day or
b. Simvastatin not more than 40 mg/day
4. LDL-cholesterol > 3.0 mmol/L (Week –1)
5. Subject able and willing to comply with all study requirements
6. 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

1. Cholesterol lowering agents other than the defined statins
2. History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study as judged by the investigator
3. Clinically significant illness or clinically relevant trauma within 2 weeks before the administration of the investigational product as judged by the investigator
4. Chronic (> 3 months) pain condition requiring daily medication with pain killers
5. Glycosylated haemoglobin (HbA1c) > 7.0%
6. Diabetes requiring medication other than metformin
7. Clinically abnormal physical findings and laboratory values as judged by the investigator and abnormal resting electrocardiogram (ECG), eg, QTc interval > 450 msec
8. Body Mass Index of = 40 kg/m^2
9. Recent history (< 3 month) of stroke or transient ischemic attacks
10. History of seizure disorder, except febrile convulsions
11. A current diagnosis of cancer, unless in remission
12. BP of > 160/95 mm Hg
13. History of cardiac arrhythmia, such as intermittent supraventricular tachyarrhythmia and atrial fibrillation
14. Unstable angina pectoris, myocardial infarction or coronary bypass graft surgery or percutaneous coronary intervention < 6 month before randomization
15. Congestive heart failure New York Heart Association Class > 2
16. Unstable or severe angina pectoris or peripheral artery disease
17. Known thyroid disease or thyroid biomarkers (thyroid-stimulating hormone [TSH], T3, free T3, T4, free T4) outside reference range for normal at enrolment and at baseline
18. Positive urine pregnancy test in women at enrolment
19. Use of thyroid replacement therapy and hormone replacement therapy (including contraceptive pills) for last 3 months before randomization
20. Positive human immunodeficiency virus (HIV) or hepatitis A, B and C, and for Epstein Barr virus and Cytomegalovirus
21. Hepatitis or liver cirrhosis
22. Bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase or -glutamyl transpeptidase > 1.5 ULN at enrollment or visit Week 1
23. 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.
24. Involvement in the planning and conduct of the study (applies to both Karo Bio AB staff and clinical research organizations)
25. Participation in a clinical study during the past 30 days anticipated to interfere with the objectives of the study as judged by the investigator
26. 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