Primary Hypercholesterolemia. MedDRA version: 8.1 Level: LLT Classification code 10020603 Term: Hypercholesterolaemia
Conditions
Interventions
Product Name: KB2115
Product Code: KB2115
Pharmaceutical Form: Gastro-resistant tablet
Current Sponsor code: KB2115
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number:
Sponsors
Karo Bio AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must be/have - primary hypercholesterolaemia, - between 18 to 65 years of age, - males or females. If females - non-nursing, non-pregnant, not of childbearing potential, i.e., either surgically sterile or post-menopausal for = 1 year, - LDL-cholesterol > 4 mmol/L at Screening and Week -1 Visit, or treated with lipid lowering medication at Screening and LDL-cholesterol > 4 mmol/L at Week - 1 Visit, - NCEP Step 1 diet during the last 4 weeks prior to randomisation, - adequate wash-out of present lipid lowering treatment. 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients must not be/have: - treatment with lipid lowering agents at randomisation, - known homozygote or heterozygote familiar hypercholesterolaemia, - HbA1c > 7.0, - diabetes requiring medication (insulin or oral diabetic treatment), - BP > 160/95, - treatment with betablockers, - BMI > 35, - history of thyroid disease, - history of cardiac arrhythmia, . CHF NYHA class > 2, - history of myocardial infarction, CABG or PCI (Percutaneous Coronary Intervention) - current angina pectoris or peripheral artery disease, - history of stroke/TIA, - ASAT & ALAT > 1.0 ULN, - history of liver disease, - hormone treatment last 3 months (including contraceptive pills), - history of alcohol and/or drug abuse within the last year, - history of coagulapathy or use of anticoagulants such as Warfarin, - history of any significant drug allergy, as judged by the investigator, - known allergy to bromide, - any other condition or circumstance that, in the opinion of the investigator, may compromise the patient's ability to comply with the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy of KB2115 in lowering LDL-cholesterol and assess safety of two doses of KB2115 versus placebo in patients with primary hypercholesterolaemia.;Secondary Objective: To identify the lipid efficacy profile of KB2115 in relation to risk markers for heart, bone, liver and muscle and to assess the kinetics of KB2115.;Primary end point(s): The primary efficacy endpoint is the change of LDL-cholesterol, from baseline to Week 12. Secondary: Effects on lipid markers: - percentage responders in each group (with 20% lowering of LDL-cholesterol; week 12 versus baseline, - total cholesterol, HDL-cholesterol, triglycerides, free fatty acids, FPLC, apolipoprotein A-I, and B, Lp(a), Cholestan (C4), lathosterol and plant sterol. | — |
Countries
Finland, Sweden
Outcome results
None listed