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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
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    The EU Clinical Trials Register currently displays   39194   clinical trials with a EudraCT protocol, of which   6422   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).
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2005-001112-41
    Sponsor's Protocol Code Number:NK-104-307
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-11-10
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2005-001112-41
    A.3Full title of the trial
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberNK-104-307
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 SponsorKOWA RESEARCH EUROPE LTD
    B.1.3.4CountryUnited Kingdom
    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.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 Yes
    D. name Livalo Tab
    D. of the Marketing Authorisation holderKowa Company Ltd
    D.2.1.2Country which granted the Marketing AuthorisationJapan
    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.3.4Pharmaceutical 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.3.9.1CAS number 147526-32-7
    D.3.9.2Current sponsor codeNK-104
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with hypercholestrolemia or combined dyslipidemia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10020603
    E.1.2Term Hypercholesterolaemia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess long-term up to 1 year safety and tolerability of pitavastatin 4 mg once daily QD .
    E.2.2Secondary objectives of the trial
    To assess the long-term efficacy of pitavastatin 4 mg QD on LDL-C levels and on other lipid and lipoprotein fractions TC, HDL-C, TC HDL-C ratio, TG, apolipoprotein A1 and B Apo-A1, Apo-B , hs-CRP, oxidized LDL and LDL-C target attainment European Atherosclerosis Society EAS and National Cholesterol Education Program NCEP .
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1 Patients have completed 12 weeks of treatment in Study NK-104-301 or NK-104-302; 2 Males and females age 18-75 years at the start of the core study . Non-pregnant, non-lactating females; 3 Patients who have not developed any treatment emergent and in the opinion of the investigator related, AE of clinical significance where the investigator is uncomfortable with continuing the patient on therapy with pitavastatin. 4 Women of child bearing potential are allowed to enter the study ONLY if they use sustained contraceptive preparations e.g., implants or intramuscular IM injections or comply with an approved mechanical contraceptive method. A woman is considered to be of childbearing potential unless she is post-hysterectomy or at least 1-year post-menopausal or post-tubal ligation. All women of child bearing potential must have a negative pregnancy test at the end of the core study NK-104-301 or NK-104-302 ; 5 Patients who are eligible and able to participate in the study and who have given written informed consent after the purpose and nature of the investigation has been explained to them; 6 Patients who have been following a fat and cholesterol restrictive diet as advised by the EAS during the dietary stabilization lead-in period before the start of the core study and through-out the entire core study NK-104-301 or NK-104-302 ; and 7 Patients who agree to be available for every clinic visit, which will occur in the morning.
    E.4Principal exclusion criteria
    1 Any conditions which may cause secondary dyslipidemia, should be reassessed at the beginning of the follow-on study.2 Uncontrolled diabetes mellitus. Patients with controlled Type II diabetes are allowed, provided the disease has been stable during at least the last 3 months prior to study entry; 3 Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug. 4 Any history of pancreatic injury or pancreatitis, or impaired pancreatic function/injury as indicated by abnormal lipase or amylase; 5 Liver injury as indicated by serum transaminase levels ALAT/serum glutamic pyruvic transaminase SGPT , ASAT/serum glutamic oxaloacetic transaminase SGOT 1.5 x upper limit of the reference range ULRR between Visit 1 and Visit 3. If ALAT/SGPT and/or ASAT/SGOT is 2 x ULRR at any time point between Visit 1 Week 0 and Visit 3 Week 8 the patient will be immediately excluded from further study participation; 6 Impaired renal function as indicated by serum creatinine levels 1.5 x ULRR at Visit 1 Week 0 ; 7 Current obstruction of the urinary tract or difficulty in voiding due to mechanical as well as inflammatory conditions, which is likely to require intervention during the course of the study or is regarded as clinically meaningful by the investigator; 8 Serum CK 5 x ULRR without clinical explanation in the absence of conditions explaining the CK elevation the patient will be immediately excluded from further study participation; 9 Uncontrolled hypothyroidism defined as TSH ULRR; 10 Any severe acute illness or severe trauma in the last 3 months prior to Visit 1 Week 0 ; 11 Evidence of symptomatic heart failure NYHA class III or IV, gross cardiac enlargement cardiothoracic ratio 0.5 ; significant heart block or cardiac arrhythmia. History of uncontrolled complex ventricular arrhythmias, uncontrolled atrial fibrillation/flutter or uncontrolled supraventricular tachycardias with a ventricular response rate of 100 beats per minute at rest. Patients whose electrophysiological instability are controlled with a pacemaker or implantable cardiac device are eligible; 12 Symptomatic cerebrovascular disease including cerebrovascular hemorrhage, transient ischemic attack, or carotid endarterectomy; 13 Any treatment emergent event in the core study, that at the discretion of the investigator which place the patient at higher risk derived from his/her participation in the study, which could confound the result of the study, or are likely to prevent the patient from complying with the requirements of the study or completing the study period; 14 Poorly controlled or uncontrolled hypertension. Patients must have a systolic blood pressure SBP 160 mm Hg and diastolic blood pressure DBP 90 mm Hg with or without antihypertensive therapy; 15 Drug abuse or continuous consumption of more than 65 mL pure alcohol per day. 16 Current or recent within 4 weeks of Visit 1 Week 0 use of supplements or medications known to alter lipid metabolism e.g. soluble fibers including 2 teaspoons Metamucil or psyllium containing supplement per day , or other dietary fiber supplements, fish oils containing Omega 3 oils, or other products at the discretion of the investigator; 17 Any concomitant medication not permitted by this protocol; 18 Excessive obesity defined as Body Mass Index BMI above 35 kg/m2 BMI body weight in kg divided by squared height m2 . Body Mass Index values should be rounded to the nearest whole number down at 0.5 and up at 0.5.
    E.5 End points
    E.5.1Primary end point(s)
    Long term safety and tolerability of Pitavastatin 4 mg QD is assessed for a period of up to 1 year.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E. trial design description
    in aperto
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    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 2006-11-10. 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 750
    F.4.2.2In the whole clinical trial 1400
    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 Decision2006-06-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-04-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-11-26
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