Hyperlipidemia
Conditions
Interventions
Trade Name: Artrox
Product Name: Artrox
Pharmaceutical Form: Tablet
INN or Proposed INN: glucosamine
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Lennart Andren
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Intolerance to glucoseamine Allergic reactions towards shellfish
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Sweden
Outcome results
None listed