hypercholesterolemia MedDRA version: 14.1 Level: LLT Classification code 10020604 Term: Hypercholesterolemia System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Cholestagel 625 mg film-coated tablets
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Each tablet contains 625 mg colesevelam (as hydrochloride)
CAS Number: 182815-44-7
Other
Sponsors
Institute for Clinical and Experimental Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether response of cholesterol concentration and concentration of 7alpha-hydroxycholest-3-en-4-one (C4) to treatment with bile acid sequestrant differ between homozygous carriers of -203C allele and homozygous carriers of -203A allele of cholesterol 7alpha-hydroxylase gene (CYP7A1) ;Secondary Objective: To determine whether treatment with bile acid sequestrant has a positive effect on selected parameters of insulin sensitivity.;Primary end point(s): Patients: 1. difference in change of cholesterol and LDL-cholesterol concentrations between homozygous carriers of -203C and -203A alleles of CYP7A1 gene after 28 days of therapy 2. difference in change of 7alpha-hydroxycholest-3-en-4-one (C4)concentration between homozygous carriers of -203C and -203A alleles of CYP7A1 gene after 28 days of therapy Sub-study in healthy volunteers: 1. difference in dynamics of change of cholesterol and LDL-cholesterol concentrations between homozygous carriers of -203C and -203A alleles of CYP7A1 gene during 28 days of therapy 2. difference in dynamics of change of 7alpha-hydroxycholest-3-en-4-one (C4) concentration between homozygous carriers of -203C and -203A alleles of CYP7A1 gene of CYP7A1 gene during 28 days of therapy;Timepoint(s) of evaluation of this end point: Patients: Day 1 - baseline Day 29 - after 28 days of therapy Sub-study in healthy volunteers: Day 1 - baseline Day 2 - after 1 day of therapy Day 4 - after 3 days of therapy Day 8 - after 7 days of therapy Day 15 - after 14 days of therapy Day 29 - after 28 days of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change in concentration of selected biochemical parametres reflecting insulin sensitivity: insulin, glucose, GLP-1, leptin, adiponectin + HOMA index (insulin*glucose/22.5);Timepoint(s) of evaluation of this end point: Patients: Day 1 - baseline Day 29 - after 28 days of therapy Sub-study in healthy volunteers: Day 1 - baseline Day 2 - after 1 day of therapy Day 4 - after 3 days of therapy Day 8 - after 7 days of therapy Day 15 - after 14 days of therapy Day 29 - after 28 days of therapy | — |
Countries
Czech Republic
Contacts
Public ContactLab for Atherosclerosis Research
Institute for Clinical and Experimental Medicine
Outcome results
None listed