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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2004-004208-19
    Sponsor's Protocol Code Number:CXUO320B2406
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-12-02
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2004-004208-19
    A.3Full title of the trial
    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
    A.4.1Sponsor's protocol code numberCXUO320B2406
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovartis Pharma Services AG
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.1.1.1Trade name Locol 80 mg Retardtabletten
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLocol
    D.3.2Product code XUO320B
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNfluvastatin
    D.3.9.1CAS number 93957-55-2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.1.1.1Trade name Ezetrol 10 mg Tabletten
    D.2.1.1.2Name of the Marketing Authorisation holderMSD-SP Ltd
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameEzetrol
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEzetimibe
    D.3.9.1CAS number 163222-33-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule*
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Dyslipidemia
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    E.2.2Secondary objectives of the trial
    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.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal 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.
    E.4Principal 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 % at week -1 (visit 2).
    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.
    E.5 End points
    E.5.1Primary 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).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    double dummy
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months10
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-12-02. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 164
    F.4.2.2In the whole clinical trial 210
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2005-05-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-06-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-01-19
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