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    Summary
    EudraCT Number:2007-004000-13
    Sponsor's Protocol Code Number:D356IC0001
    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:2007-11-28
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2007-004000-13
    A.3Full title of the trial
    A 104-week, randomized, double-blind, parallel group, multi-center Phase IIIb study comparing the effect of treatment with rosuvastatin 40mg or atorvastatin 80mg on atherosclerotic disease burden as measured by intravascular ultrasound in patients with coronary artery disease. - SATURN : Study of Coronary Atheroma by InTravascular Ultrasound: Effect of Rosuvastatin Versus Atorvastatin.
    A.3.2Name or abbreviated title of the trial where available
    SATURN
    A.4.1Sponsor's protocol code numberD356IC0001
    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 SponsorASTRAZENECA
    B.1.3.4CountryItaly
    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 Yes
    D.2.1.1.1Trade name CRESTOR*28CPR RIV 40MG
    D.2.1.1.2Name of the Marketing Authorisation holderASTRAZENECA SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.8INN - Proposed INNRosuvastatin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 Yes
    D.2.1.1.1Trade name LIPITOR*10CPR 40MG
    D.2.1.1.2Name of the Marketing Authorisation holderBIOINDUSTRIA FARMACEUTICI Srl
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.8INN - Proposed INNAtorvastatin
    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.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 coronary artery disease
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10011078
    E.1.2Term Coronary artery disease
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to compare the effects of rosuvastatin 40mg with atorvastatin 80mg on the percent atheroma volume (PAV) of a coronary artery as measured by
    intravascular ultrasound (IVUS) imaging following 104 weeks of treatment in patients with coronary artery disease (CAD).
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    1. To determine whether 104 weeks (24 months) of treatment with rosuvastatin 40mg or atorvastatin 80mg shows regression of PAV in the targeted coronary artery as measured by IVUS.
    2. To compare the effects of rosuvastatin 40mg with atorvastatin 80mg on the total atheroma volume (TAV) in the targeted coronary artery as measured by IVUS.
    3. To compare the effects of rosuvastatin 40mg with atorvastatin 80mg on lipid and lipoprotein metabolism.
    4. To assess the safety and tolerability of rosuvastatin 40mg and atorvastatin 80mg during the 104 weeks of treatment in patients with CAD.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Signed written informed consent
    2. Men or women 18 to 75 years of age.
    3. Women must be non-lactating, not of childbearing potential or using a reliable method of birth control considered suitable by the Investigator.
    4. Clinical indication for coronary angiography.
    5. Willing study procedures: adherence to lipid-lowering diet,
    study visits, fasting blood draws and compliance with study treatment regimen.
    3. Target Coronary Artery:
    Must be accessible to the IVUS catheter.
    Must have a < 50% reduction in lumen diameter by angiographic visual estimation throughout a target segment of at least 40 mm in length (the “target segment”). A
    lesion of up to 60% stenosis is permitted, distal to the target segment. A single branch of the “target vessel” may have a narrowing up to but < 70% by visual estimation as long as the target segment contains no lesion > 50%, and provided that the branch in question is not, and will not be, a target for percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) during the course of the study.
    Has not sustained a myocardial infarction (MI).
    Has not undergone prior PCI or CABG surgery.
    The target vessel is not currently a candidate for intervention or a likely candidate for intervention over the next 24 months.
    The target vessel may not be a bypass graft.
    . The target vessel may not be a bypassed vessel.
    E.4Principal exclusion criteria
    Patients must not have been treated with lipid-lowering medications
    for more than 3 months in the past 12 months.
    .Patients who have symptoms consistent with moderate or greater severity of
    congestive heart failure (CHF), or whose most recent determination of left ventricular ejection fraction (LVEF)
    is <0.35, by contrast left ventriculography, radionuclide ventriculography or
    echocardiography.
    . Uncontrolled hypertension at Visit 2,
    . Known serious or hypersensitivity reactions to HMG-CoA reductase inhibitors.
    . Triglyceride (TG) level &#8805;500 mg/dL (5.65 mmol/L) at screening
    . Creatine kinase (CK) >3 times the upper limit of the normal (ULN) range at
    screening,
    . Known major hematologic, neoplastic, metabolic, gastrointestinal or endocrine
    dysfunction which, in the judgment of the Investigator
    . History of malignancy, except in patients who have been disease-free >5 years or
    whose only malignancy has been basal or squamous cell skin carcinoma.
    . Life-threatening illness indicating the patient is not expected to survive for 104 weeks.
    . Unreliability as a study participant based on the Investigator’s knowledge of the
    patient, such as drug or alcohol abuse.
    . Uncontrolled diabetes, defined as glycosylated hemoglobin (HbA1C) >10% at
    screening.
    . Active liver disease or hepatic dysfunction, as determined by aspartate
    aminotransferase (AST [SGOT]), alanine aminotransferase (ALT [SGPT]) or
    bilirubin levels &#8805;1.5 x ULN at screening, because of the potential of statins to cause
    disturbances in liver function Secondary causes of hyperlipoproteinemia, such as uncontrolled primary
    hypothyroidism (defined as thyroid stimulating hormone [TSH] &#8805;1.5 x ULN),
    nephrotic syndrome, and/or renal dysfunction (serum creatinine &#8805;2.0 mg/dL [177
    &#956;mol/L]) at screening.
    . Coronary artery bypass surgery <6 weeks prior to the qualifying IVUS.
    E.5 End points
    E.5.1Primary end point(s)
    The nominal change (end of treatment minus pre-treatment) in percent atheroma volume
    (PAV) in a &#8805;40 mm segment of one targeted (imaged) coronary artery for all anatomically
    comparable slices (end of treatment and pre-treatment), as measured by IVUS.
    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 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.7.1.3.1Other 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 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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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 2007-11-28. 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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 290
    F.4.2.2In the whole clinical trial 1300
    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 Decision2006-03-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-11-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-06-16
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