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    Summary
    EudraCT Number:2006-003286-14
    Sponsor's Protocol Code Number:D3560L00060
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2006-07-22
    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 ConcernedUK - MHRA
    A.2EudraCT number2006-003286-14
    A.3Full title of the trial
    A phase IV, 6-week, randomised, double-blind, multicentre, parallel group, comparative study to evaluate the efficacy of rosuvastatin 5 mg and atorvastatin 10 mg in UK Asian subjects with primary hypercholesterolaemia
    A.3.2Name or abbreviated title of the trial where available
    SHUKRA
    A.4.1Sponsor's protocol code numberD3560L00060
    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 UK 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.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 UK Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    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.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
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Ireland Pharmaceuticals
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameatorvastatin
    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.3.11 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 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
    Hypercholesterolaemia
    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
    The primary objective of this UK study is to compare the efficacy of rosuvastatin 5 mg with atorvastatin 10 mg in reducing LDL-C in Asian subjects with hypercholesterolaemia after 6 weeks of treatment.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to compare the efficacy of rosuvastatin 5mg with atorvastatin 10mg in Asian subjects with hypercholesterolaemia by assessing:

    1. The percentage of subjects reaching the General Medical Services (GMS) contract
    target of TC <5 mmol/L, after 6 weeks of treatment

    2. The percentage of subjects reaching the Joint British Societies’ Guideline (JBS 2)
    targets of TC <4 mmol/L and LDL-C <2 mmol/L, after 6 weeks of treatment

    3. The percentage of subjects reaching the European (EAS) targets for LDL-C or combined LDL-C and TC, dependent on risk category

    4. The percentage change from baseline in TC, HDL-C, TG, non-HDL-C, ApoB,
    ApoA1, LDL-C/HDL-C ratio, TC/HDL-C ratio, non-HDL-C/HDL-C ratio and ApoB/ApoA1 ratio after 6 weeks of treatment

    5. The safety and tolerability of treatment with rosuvastatin and atorvastatin during the 6-week treatment period
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For inclusion in the study dietary run-in period subjects must fulfil all of the following
    criteria:

    Visit 1:
    1. Provision of written informed consent
    2. Self-described Asian, first or second generation (includes origin of India, Pakistan,
    Bangladesh, Sri Lanka, Nepal, Bhutan, Japan, China, Phillipines, Vietnam , Korea,
    Indonesia and Malaysia, and the intention to reside in the UK for the duration of the
    study)
    3. Males or females aged ≥ 18 years. There is no upper age limit
    4. Subjects with primary hypercholesterolaemia
    5. Fasting LDL-C of 3.5 - 5.7 mmol/L (statin naive subjects) or 2.6 - 4.2 mmol/L (in subjects who have taken a statin within 4 weeks of Visit 1)and TG <4.52 mmol/L (all subjects) determined from blood samples collected at Visit 1

    For inclusion into the treatment period of the study, subjects must fulfil the following criteria:

    6. Fasting LDL-C of 3.5 - 5.7mmol/L (all subjects) and TG <4.52 mmol/L determined from blood samples collected at Visit 2
    E.4Principal exclusion criteria
    Any of the following is regarded as a criterion for exclusion from the study:

    1. Use of cholesterol-lowering drugs, the continued use of lipid-regulating dietary
    supplements or food additives after Visit 1
    2. History of serious hypersensitivity reactions to other HMG-CoA reductase
    inhibitors
    3. Pregnancy or lactation. Women of child bearing potential must have a negative
    pregnancy test at Visit 1, and use a reliable method of contraception i.e. hormonal
    contraceptives, double-barrier methods, intra-uterine device or tubal ligation, unless
    their sexual partner is sterile
    4. Active arterial disease such as unstable angina, myocardial infarction (MI), transient ischaemic attack (TIA), cerebrovascular accident (CVA), coronary artery bypass graft (CABG) surgery or angioplasty within 3-months of study entry
    5. Poorly controlled diabetes, as defined by glycosylated haemoglobin (HbA1c) ≥9%
    at Visit 1. Subjects with a history of diabetic ketoacidosis within the past 5-years
    are also excluded
    6. Uncontrolled hypothyroidism as defined as a thyroid stimulating hormone (TSH) >
    1.5 X ULN at Visit 1 or subjects whose thyroid replacement therapy was initiated
    within the last 3 months
    7. History of alcohol and/or drug abuse during the preceding 5-years
    8. Active liver disease or hepatic dysfunction, as defined by elevations of >3 x ULN at
    Visit 1 in any of the following liver function tests: alanine aminotranferase (ALT),
    aspartate aminotranferase (AST) or bilirubin
    9. Unexplained serum creatine kinase (CK) >5 x ULN at Visit 1(eg., not due to recent
    trauma, intra-muscular injections, heavy exercise etc)
    10. Renal insufficiency as defined by serum creatinine >177μmol/L (2.0 mg/dL) at
    Visit 1
    11. Serious or unstable medical or psychological conditions that, in the opinion of the
    investigator would compromise the subject’s safety or successful participation in
    the study
    12. History of malignancy, except subjects who have been disease-free for more than 5 years, or whose malignancy has been basal or squamous cell skin carcinoma
    13. History of homozygous familial hypercholesterolaemia
    14. Previous enrolment or randomisation of treatment in this study
    15. Participation in another clinical study during the last 90 days.
    16. Use of contraindicated concomitant medications, as detailed in section 3.7
    17. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)

    Laboratory results should be reviewed in a timely manner from receipt at site, in order to assess patient’s eligibility for continuation into the dietary lead in/ wash-out period. Following review of results, if a subject no longer meets inclusion/ exclusion criteria the Investigator should contact the subject and inform them that they will no longer be required to participate in the study.

    In addition, the following are regarded as criteria for exclusion into the randomised treatment period (Visit 3), determined from blood samples taken at visit 2:

    18. Active liver disease or hepatic dysfunction, as defined by elevations of >3 x ULN in any of the following liver function tests: alanine aminotranferase (ALT), aspartate
    aminotranferase (AST) or bilirubin at Visit 2
    19. Unexplained serum creatine kinase (CK) >5 x ULN (eg., not due to recent trauma,
    intra-muscular injections, heavy exercise etc) at Visit 2
    20. Serum creatinine >177μmol/L (2.0 mg/dL) at Visit 2
    E.5 End points
    E.5.1Primary end point(s)
    Reduction in LDL-C from baseline (week 6) to week 12.
    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 No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    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 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) 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 No
    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.8.4.1Number of sites anticipated in Member State concerned75
    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
    Last visit of last subject
    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 months3
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state750
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Normal treatment for hypercholesterolaemia
    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 Decision2006-08-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-09-18
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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