Do treatment with glucosamine interfere with the lipid lowering effects of simvastatin and atorvastatin?
- Conditions
- Hyperlipidemia
- Registration Number
- EUCTR2006-001458-28-SE
- Lead Sponsor
- ennart Andren
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Patients with hypercholesterolemia treated with a stable dose of either atorvastatin (10 -40 mg) or simvastatin (10-40 mg) for at least 3 months.
Age 18- 85 years
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
Intolerance to glucoseamine
Allergic reactions towards shellfish
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: Secondary objectives are to study changes in total-cholesterol, HDL, cholesterol, triglycerides, blood glucose and HBA1c;Primary end point(s): Change in LDL-cholesterol after 1 month of treatment with glucosamine compared to change in LDL-cholesterol after 1 month of treatment with control (multivitamins).;Main Objective: This is a study to invetigate if there is pharmacodynamic interaction between glucosamine and simvastatin/atorvastatin. Thus 50 patients with hyperlipidemia are given glucosamine or control (multivitamins) and blood lipids are measured as efficacy variables. The main efficacy variable is change in LDL-kolesterol after 1 month of treratment with glucosamine compared with change in LDL-kolesterol levels after one month of treatment with control in patients on a stable dose of either simvastatin or atorvastatin
- Secondary Outcome Measures
Name Time Method