A 12-week multicentre, double blind, double dummy, randomized, parallel group, active controlled study to evaluate the efficacy and tolerability of fluvastatin extended release (Lescol XL® 80 mg) alone or in combination with ezetimibe10 mg as compared to ezetimibe monotherapy, in dyslipidemic patients with previous history of muscular complaints with other statins

Phase 1

• Conditions: Dyslipidemia

• Registration Number: EUCTR2004-004208-19-NO
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-03-16
• Study Completion: 2005-12-23
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

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 < 500 mg/dL, aged ? 18 years. Pre-menopausal non-pregnant, non-lactating women are allowed, the latter if using oral contraceptives, approved mechanical (copper-coated IUD, condom) contraceptive methods together with a spermicidal, or underwent hysterectomy, or had tubal ligation for at least 1 year. All women of child bearing potential must have a negative pregnancy test at study entry.

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

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 < 3 months and/or HbA1C level > 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified