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    Summary
    EudraCT Number:2008-002332-15
    Sponsor's Protocol Code Number:D1840M00006
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-08-07
    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 ConcernedSweden - MPA
    A.2EudraCT number2008-002332-15
    A.3Full title of the trial
    A randomised, double-blind, placebo-controlled study to evaluate the transthoracic Doppler echocardiography method as a non-invasive method for coronary function measurements; ability to detect short-term statin effects in patients with increased cardiovascular risk
    A.4.1Sponsor's protocol code numberD1840M00006
    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 AB
    B.1.3.4CountrySweden
    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
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 namerosuvastatin
    D.3.4Pharmaceutical form Film-coated 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.3.9.3Other descriptive namerosuvastatin calcium
    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 No
    D.3.11.8Extractive medicinal product No
    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 placeboFilm-coated tablet
    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
    In this study the IMP, rosuvastatin, is used as a tool compound for creating favourable lipid-altering, anti-inflammatory or other pleiotropic effects which are believed to change coronary flow reserve (CFR).
    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
    · To evaluate the change after 1 month statin treatment in transthoracic Doppler echocardiography-coronary flow reserve (TTDE-CFR) peak velocity compared to baseline within the rosuvastatin 40 mg group

    · To evaluate the difference in treatment effects on CFR peak velocities after 1 month between the rosuvastatin group and the placebo group in favour of the rosuvastatin group
    E.2.2Secondary objectives of the trial
    • Changes in CFR peak velocity within the rosuvastatin group after 3 months
    compared to baseline and to 1 month
    • Changes in other CFR parameters after 1 month rosuvastatin treatment or placebo;
    comparisons within groups and between groups, respectively
    • Changes in plasma lipids, lipoproteins and other cardiovascular biomarkers after
    1 month of treatment with rosuvastatin or placebo; comparisons within groups and
    between groups, respectively
    • Rosuvastatin treated group only: changes within group in plasma lipids, lipoproteins and other cardiovascular biomarkers after 3 months of treatment with rosuvastatin compared to baseline and to 1 month, respectively
    • Explore relationships between CFR and plasma biomarkers, also after consideration
    of baseline characteristics of the subjects
    • To receive information on the variability of included variables
    • To collect and store DNA for future exploratory research into genes related to
    atherosclerotic and cardiovascular disease
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males aged 45-75 years or females aged 60-75 years inclusive
    2. Carotid and/or femoral atherosclerotic plaque(s), defined as a distinct area with an
    intima media thickness (IMT) >50% thicker than that of neighbouring sites
    (visually judged), as previously assessed by carotid ultrasound examination within
    the last 5 years
    3. Dyslipidaemia: Apolipoprotein (Apo)B/A1 ratio >0.60
    4. Provision of signed informed consent
    E.4Principal exclusion criteria
    1. Treatment with statins or other lipid-lowering drugs, e.g. fibrates, nicotinic acid,
    cholesterol absorption inhibitor, within the last 6 months before randomisation
    2. Treatment with Persantin® or Asasantin® or other dypyridamole-like drugs
    3. Treatment with glitazones or other peroxisome proliferator-activated receptors
    (PPAR) α/γ agonists, metformin or insulin within the last 6 months
    4. Known hypersensitivity to statins, adenosine or mannitol
    5. Haemoglobin A1c (HbA1c) >7.5 % (Swedish standard) or random glucose
    >15 mmol/L at Enrolment visit
    6. Initiation, cessation or dose change in any anti-diabetic medication within the last
    3 months before randomisation
    7. Initiation, cessation or dose change in any treatment with beta-blockers,
    Angiotensin-Converting Enzyme inhibitors (ACEi) or Angiotensin receptor
    blockers (ARBs) within the last 3 months before randomisation
    8. Uncontrolled hypertension according to the investigator
    9. Current smoking or snuff tobacco use
    10. Major CV event (myocardial infarction (MI), stroke/ transitory ischemic attack
    (TIA), Acute Coronary Syndrome (ACS), revascularisation) within the last
    6 months before randomisation
    11. Symptomatic carotid stenosis, atrioventricular (AV) block, QT-prolongation, atrial fibrillation, sinus
    node disease (such as sick sinus syndrome or symptomatic bradycardia), chronic
    obstructive pulmonary disease (COPD) or asthma
    12. History of myopathy, alcohol or drug abuse, epilepsy or seizures
    13. A calculated creatinine-clearance corresponding to a GFR <60 ml/min (Cockroft-Gault), Creatine kinase (CK) > 3 x upper limit of normal (ULN),
    liver transaminases > 1.5 x ULN or anaemia
    14. Hypothyroidism, in terms of a thyroid stimulating hormone (TSH) ≥ 1.5 x ULN
    (patients with diagnosed hypothyroidism on replacement therapy are allowed
    provided they do not meet this TSH criterion)
    15. Asian ethnicity, treatment with Vitamin K antagonists, protease inhibitors, rifampicine, cyclosporine or high-dose treatment with macrolide antibiotics
    16. Malignant disease (except in patients who have been disease-free >5 years or whose only malignancy has been basal or squamous cell skin carcinoma), kidney disease, hepatic disease or inflammatory bowel disease
    17. Systemic inflammatory disease or use of systemic corticosteroid treatment
    18. Positive screen for Serum Hepatitis B Surface Antigen, Hepatitis C Antibodies and
    human immunodeficiency virus (HIV)
    19. Donation of blood or plasma in any amount during the month prior to baseline visit or in excess of 170 mL during the 3 months prior to study start.
    20. Previous bone marrow transplant (excludes only participation in the genetic
    sampling)
    21. Whole blood transfusion within 120 days of the date of genetic sample collection
    22. Intake of any investigational product within the last month before enrolment
    23. Any other condition prohibiting study participation at the discretion of the
    investigator
    E.5 End points
    E.5.1Primary end point(s)
    The main purpose of this study is to evaluate the usefulness of Transthoracic Doppler Echocardiography (TTDE) to assess coronary flow reserve (CFR) and how it can be utilized as a composite biomarker for coronary artery function. Ultimately, the method may be used for monitoring drug effects in patients with increased cardiovascular risks.
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    The study will evaluate the TTDE CFR method
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.7.1Other trial design description
    A double-blind, randomised, placebo-contr 1-month study, with 2-month open extension of active arm
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    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
    End of study is defined as the last subject’s last visit.
    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 months6
    E.8.9.1In the Member State concerned days
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    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 Decision2008-09-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-08-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-05-07
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