Heredity and treatment of increased cholesterol concentratio

Phase 1

Conditions: hypercholesterolemia
MedDRA version: 14.1Level: LLTClassification code 10020604Term: HypercholesterolemiaSystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2012-001638-33-CZ

Lead Sponsor: Institute for Clinical and Experimental Medicine

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 66

Inclusion Criteria

Patients:
- sex: males and females
- age: 18 - 65 years
- confirmation of contraception used (in fertile women)
- LDL-cholesterol (calculated) > 3 mmol/l
- homozygote for -203A or -203C allele of CYP7A1 gene

Sub-study in healthy volunteers:
- sex: males
- age: 18 - 65 years
- BMI < 30 kg/m2
- total cholesterol > 5 mmol/l
- homozygote for -203A or -203C allele of CYP7A1 gene
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 66
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients:
- triglyceride > 3 mmol/l
- pregnancy, breast-feeding
- treatment with hypolipidemic drugs and oral anticoagulants
- decompensated diabetes mellitus
- insulin treatment
- serious thyreopathy
- presence of another confirmed serious disease that could endanger or disadvantage the patient if included into the trial
- hypersensitivity to colesevelam or any of the excipients
- intestine or bile duct obstruction, obstipation

Sub-study in healthy volunteers:
- triglyceride > 3 mmol/l
- presence of confirmed serious disease such as ischemic heart disease, diabetes mellitus, thyreopathy, nephrotic syndrome, dysproteinemia and others that could endanger or disadvantage the subject if included into the trial
- alcoholism
- mental disorders
- hypersensitivity to colesevelam or any of the excipients
- intestine or bile duct obstruction, obstipation