Dyslipidemia
Conditions
Interventions
Product Name: Lescol XL
Product Code: XUO320B
Pharmaceutical Form: Tablet
INN or Proposed INN: fluvastatin
CAS Number: 93957-55-2
Current Sponsor code: XUO320
Concentration unit: mg milligram(s)
Conce
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provide informed consent and agree to attend all clinical visits 2. Dyslipidemic patients with history of muscle related side effects that had caused cessation of statin therapy or currently suffering from muscle related side effects (under statin treatment other than fluvastatin) which affects the patient’s quality of life. 3. Male and female patients with triglycerides levels =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with homozygous familial hypercholesterolemia, and Fredrickson Types I, IV and V dyslipoproteinemia. 2. History or evidence of myositis or asymptomatic CK elevation > 10 x ULN. 3. History of rhabdomyolysis, or any congenital muscular disease. 4. Unstable patients with secondary hypercholesterolemia, e.g. patients treated for hypothyroidism must have a TSH level ? 1.5 x ULN at week -1 (visit 2). 5. Unstable diabetic patients, e.g. patients on anti diabetic therapy 8 %. 6. Patients requiring lipid-altering medication other than those used in the study. A 4-week (prior to Visit 2/Week -1) wash-out period from HMG-CoA reductase inhibitors, fibric acid derivatives, bile acid binding resins, niacin or ezetimibe is required. 7. History of hypersensitivity or muscle related side effects with fluvastatin. 8. History of hypersensitivity or intolerance to ezetimibe. 9. ALT/SGPT and/or AST/SGOT > 2 x ULN at Visit 2/Week -1. 10. Severe renal function impairment (defined as creatinine blood level > 2.5 mg/dL and/or proteinuria > 1.5 g/24 hours). 11. Unexplained serum CK levels > 3 x ULN at Visit 2/Week -1. 12. Treated or untreated uncontrolled hypertensive patients. 13. History of acute coronary syndrome (i.e., unstable angina and myocardial infarction), arterial revascularization, coronary artery bypass graft surgery, and cerebral stroke within 6 months prior to Visit 1. 14. History of congestive heart failure (e.g., New York Heart Association Class III and IV). 15. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug including but not limited to any of the following: • History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection. • Active inflammatory bowel syndrome within 12 months. • Active gastritis, ulcers or gastrointestinal/rectal bleeding. • Any history of pancreatic injury, pancreatitis or evidence of impaired pancreatic function/injury as indicated by abnormal lipase or amylase. 16. Patients with a HIV diagnosis, or currently treated for HIV. 17. History of malignancy including leukemia and lymphoma within the past 5 years. Basal cell skin cancer is allowed. 18. Exposure to any investigational new drug 30 days prior to visit 1. 19. History of drug or alcohol abuse within the past 2 years. 20. Severe illness/trauma, major surgery, within 3 months. 21. Any other conditions that, at the discretion of the investigator, place the patient at higher risk from his/her participation to the study, or are likely to prevent compliance and/or completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To assess the efficacy of fluvastatin extended release (Lescol XL 80 mg) in combination with ezetimibe 10 mg on LDL-C reduction versus ezetimibe 10 mg monotherapy in dyslipidemic patients intolerant to other statins due to muscle related side effects. 2. To assess the efficacy of fluvastatin extended release (Lescol XL 80 mg) on LDL-C reduction versus ezetimibe 10 mg monotherapy in dyslipidemic patients intolerant to other statins due to muscle related side effects. ;Secondary Objective: 1.To assess tolerability of fluvastatin extended release (Lescol XL 80 mg), ezetimibe 10 mg, and their combination as determined by rate of recurrence of muscle related side effect and rate of recurrence of muscle related side effects leading to study drug discontinuation. 2.To assess lipid altering effects of fluvastatin extended release (Lescol XL 80 mg), ezetimibe 10 mg, and their combination on total cholesterol (TC), triglycerides (TG), high density lipoprotein cholesterol (HDL-C), LDL-C:HDL-C ratio, apolipoprotein AI (Apo-AI), and Apo-B as compared to ezetimibe 10 mg and combined regimen. 3.To explore number of patients who reach the LDL-C target according to the current NCEP guidelines among the different treatment groups. 4.To explore overall safety and tolerability profile of fluvastatin extended release (Lescol XL 80 mg), ezetimibe 10 mg and their combination. ;Primary end point(s): The primary efficacy variable is the percent change from baseline in LDL C at the end of the study, week 12 (LOCF). Baseline will be the value obtained at visit 3 (randomization visit). | — |
Countries
Germany, Norway
Outcome results
None listed