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    Summary
    EudraCT Number:2007-002810-20
    Sponsor's Protocol Code Number:D356FC00003
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-08-07
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2007-002810-20
    A.3Full title of the trial
    A 12-week Open-Label, Randomised, Parallel-group, Multicentre, Phase IIIb Study to compare the Efficacy and Safety of rosuvastatin (CRESTOR) 10 mg and 20 mg in Combination with Ezetimibe 10 mg and Sivastatin 40 mg and 80 mg in Combination with Ezetimibe 10 mg (fixed dose combination) in Patients with Hypercholesterolaemia and Coronary Heart Disease (CHD) or a CHD Risk Equivalent, Atherosclerosis or a 10-year CHD Risk of >20% (GRAVITY)

    A.3.2Name or abbreviated title of the trial where available
    Gauging the lipid effects of RosuvAstatin plus ezetimibe Versus sImvastatin plus ezetimibe TherapY
    A.4.1Sponsor's protocol code numberD356FC00003
    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 UK Ltd
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 calcium
    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 calcium
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNrosuvastatin calcium
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 ZOCOR
    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 namesimvastatin
    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 INNsimvastatin
    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.IMP: 3
    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 ZOCOR
    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 namesimvastatin
    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 INNsimvastatin
    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 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: 4
    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 EZETROL
    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 nameezetimibe
    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 INNezetimibe
    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 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: 5
    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 Inegy
    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 namesimvastatin/ezetimibe
    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 INNsimvastatin/ezetimibe
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40/10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsimvastatin/ezetimibe
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80/10
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Dyslipidemia - Expert groups have identified low-density lipoprotein cholesterol (LDL-C) as the primary target for cholesterol lowering therapy because it is strongly associated with coronary heart disease (CHD) risk but, more importantly, clinical studies document that lowering LDL-C reduces the risk for major CHD events (Expert Panel NCEP ATP III 2001: De Backer et al 2003; American Heart Association (AHA)/American College of Cardiology (ACC): Smith et al 2006).
    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
    The primary objective of this study is to evaluate the LDL-C lowering efficacy of rosuvastatin 10 mg and 20 mg in combination with ezetimibe relative to that of simvastatin in a fixed dose combination with ezetimibe. This objective has 3 specific components:
    1. Percentage change from baseline in LDL-C for rosuvastatin 20mg in combination with ezetimibe 10mg vs simvastatin 40mg in combination with ezetimibe 10mg after 6 weeks combination therapy (mean value of 4 and 6 weeks of combination therapy will be used)
    2. Percentage change from baseline in LDL-C for rosuvastatin 10mg in combination with ezetimibe 10mg vs simvastatin 40mg in combination with ezetimibe 10mg after 6 weeks combination therapy (mean value of 4 and 6 weeks of combination therapy will be used)
    3. Percentage change from baseline in LDL-C for rosuvastatin 20mg in combination with ezetimibe 10mg vs simvastatin 80mg in combination with ezetimibe 10mg after 6 weeks combination therapy
    E.2.2Secondary objectives of the trial
    1. The percent change in LDL-C of rosuva 10mg/ezetimibe 10 vs simva 80mg/ezetimibe 10 mg
    2. The percent change in HDL-C, TC, TG, nonHDL-C, ApoB, ApoA-1 of of rosuva 10mg/ezetimibe 10 vs simva 80mg/ezetimibe 10 mg
    3. rosuva 20/ezetimibe 10 vs simva 40 mg/ezetimibe 10mg on the proportion of patients achieving lipid goals after 6 weeks.
    4. rosuva 10/ezetimibe 10 vs simva 40 mg/ezetimibe 10mg on the proportion of patients achieving lipid goals after 6 weeks.
    5. rosuva 20/ezetimibe 10 vs simva 80 mg/ezetimibe 10mg on the proportion of patients achieving lipid goals after 6 weeks.
    6. rosuva 10/ezetimibe 10 vs simva 80 mg/ezetimibe 10mg on the proportion of patients achieving lipid goals after 6 weeks.
    7. To assess rosuva 10mg and 20mg with ezetimibe 10mg vs the same dose of rosuva alone on the percent change in lab values
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    There is an optional research activity that is contained with in the CSP in Appendix K. This is therefore under the same full title of the main study but has the following objective

    Optional Genetic Research

    To obtain, with appropriate informed consent, DNA samples for future exploratory research on the effects of genetic polymorphisms on

    - Response to rosuvastatin and ezetimibe conbination therapy
    -Susceptibility to and prognosis of coronary heart disease (CHD) and lipid disorders
    E.3Principal inclusion criteria
    At Visit 1 (Week -6)
    For inclusion in the dietary lead-in phase, patients must fulfil all of the following criteria at Visit 1:
    1. Provision of signed written informed consent
    2. Male or female patients aged 18 years of age or older.
    3. A history of CHD or a CHD risk equivalent, clinical evidence of atherosclerosis (definitions given in Appendix G) or a 10-year Framingham risk score of >20% for CHD, as described in NCEP ATP III guidelines
    4. The patient must have a reasonable likelihood of attaining LDL-C values of ≥ 130 mg/dL to <220 mg/dL at Visit 2, in the opinion of the Investigator. Based upon the experience of previous studies, the following guidance can be used in interpreting Visit 1 LDL-C results:
    o ≥ 125 mg/dL (3.24 mmol/L) to <220 mg/dL (5.69 mmol/L) in statin-naïve patients (patients who have not taken any lipid-lowering therapy known to affect LDL-C in the 4 weeks prior to Visit 1)
    o ≥ 90 mg/dL (2.33 mmol/L) to <180 mg/dL (4.66 mmol/L) in patients who have taken lovastatin, fluvastatin, or pravastatin within 4 weeks of Visit 1
    o ≥ 70 mg/dL (1.81 mmol/L) to <160 mg/dL (4.14 mmol/L) in patients who have taken simvastatin, atorvastatin, rosuvastatin or any statin in combination with ezetimibe within 4 weeks of Visit 1
    5. Fasting TG concentrations <400 mg/dL (4.52 mmol/L)
    6. Patients willing to follow all study procedures including attendance at clinics for scheduled study visits, fasting prior to clinic visits (all visits blood draws) and compliance with study treatment regimen
    For inclusion in the biomarker research, patients must fulfil the following criterion:
    · Provision of written informed consent for biomarker research.
    For inclusion in the genetic research, patients must fulfil the following criterion:
    · Provision of written informed consent for genetic research. Any additional criteria are provided in Appendix K
    If a patient declines to participate in the biomarker or genetic research, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study described in this CSP, so long as they consent.
    Randomised treatment period
    For inclusion into the randomised treatment phase of the study, patients must fulfil the following criteria:
    1. Fasting LDL-C concentrations of ≥ 130 mg/dL (3.36 mmol/L) to <220 mg/dL (5.69 mmol/L) at Visit 2
    2. Fasting TG concentrations <400 mg/dL (4.52 mmol/L) at Visit 2
    E.4Principal exclusion criteria
    At Visit 1 (Week -6)
    Any of the following is regarded as a criterion for exclusion from the study:
    1. Use of lipid lowering drugs and other prohibited concomitant medications from Visit 1 (see Section 3.7)
    2. History of statin-induced myopathy, or serious hypersensitivity reaction to other HMG-CoA reductase inhibitors (statins), including rosuvastatin, simvastatin and/or a history of hypersensitivity to any components of ezetimibe
    3. Pregnant women, women who are breast feeding, and women of childbearing potential who are not using chemical or mechanical contraception or have a positive serum pregnancy test (serum β-HCG analysis)
    4. Patients considered to be unstable by the Investigator after the following events (event within 8 to 12 weeks of study entry (Visit 1) at the Investigators discretion): a myocardial infarction, recent episode of unstable angina, myocardial revascularisation [percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass graft (CABG) surgery or another revascularisation procedure] or a transient ischaemic attack (TIA) or stroke. (These patients should be on a statin and should not be entered into a washout phase, therefore they are unsuitable for this study)
    5. Severe congestive cardiac failure (New York Heart Association [NYHA] Class IIIb or IV) (see Appendix H). (There is no evidence that these patients benefit from statin therapy)
    6. Patients awaiting a planned myocardial revascularisation prior to Visit 1. (These patients require statin therapy and so a washout phase is not appropriate; therefore they are unsuitable for this study)
    7. History of malignancy with the exception of resected basal cell or squamous cell carcinoma of the skin. Women with a history of cervical dysplasia will be permitted to enter the study provided they have 3 consecutive clear Papanicolaou (Pap) smears. (So that patients who are at risk of recurrence of malignancy requiring treatment are not included)
    8. History of homozygous familial hypercholesterolaemia (the severity of hypercholesterolaemia in these patients usually dictates the need for individualised treatment regimens which can include phoresis)
    9. History of alcohol or drug abuse within the last 5 years
    10. Current active liver disease [alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase (SGPT)) ≥ 2 x upper limit of normal (ULN)] or severe hepatic impairment
    11. Participation in another investigational drug study (including a previous rosuvastatin study) <4 weeks before enrolment in the study, or according to patient’s local ethics committee requirements where a longer period is stipulated
    12. Patients previously screened for this study
    13. Serious or unstable medical or psychological conditions that, in the opinion of the Investigator, would compromise the patient’s safety or successful participation in the study
    14. Patients whose hormone replacement therapy (HRT) or oral contraceptive therapy (OCT) was initiated or changed within the 3 months prior to enrolment in the dietary lead in phase. (Changes in female hormones can have an effect on lipid measurements)
    At randomisation visit
    15. Patients with uncontrolled hypothyroidism within 3 months prior to enrolment in the dietary lead-in phase, defined as a TSH >1.5 x ULN (this is due to the relationship between myopathy and patients with hypothyroidism undergoing statin therapy)
    16. Patients with unexplained creatine kinase (CK) within 3 months prior to enrolment in the dietary lead-in phase, defined as >1 x ULN
    17. Serum creatinine >176 μmol/L or 2.0 mg/dL at Visit 2. (This is consistent with other statin studies previously performed)
    E.5 End points
    E.5.1Primary end point(s)
    Primary outcome variable:
    · Percentage LDL-C change from baseline to 6 weeks (mean of weeks 4 and 6) of combination therapy
    · Statistical significance of the following 3 comparisons will be tested simultaneously by a Hochberg procedure to control for multiple comparisons:
    1. Rosuvastatin 20 mg + ezetimibe 10mg vs simvastatin 40 mg+ 10 mg ezetimibe.
    2. Rosuvastatin 10 mg + ezetimibe 10mg vs simvastatin 40 mg+ 10 mg ezetimibe.
    3. Rosuvastatin 20 mg + ezetimibe 10mg vs simvastatin 80 mg+ 10 mg ezetimibe
    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 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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 Yes
    E.8.2.3.1Comparator description
    Simvastatin, simvastatin/ezetimibe
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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 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
    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
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 800
    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 Decision2007-08-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-09-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-12-12
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