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    Summary
    EudraCT Number:2006-006697-15
    Sponsor's Protocol Code Number:D3560L00068
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2007-02-23
    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 ConcernedFrance - ANSM
    A.2EudraCT number2006-006697-15
    A.3Full title of the trial
    Evaluation de l'efficacité et de la tolérance de rosuvastatine 5 mg versus pravastatine 40 mg et atorvastatine 10 mg chez des patients hypercholestérolémiques de type IIa et IIb
    A.4.1Sponsor's protocol code numberD3560L00068
    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 SAS
    B.1.3.4CountryFrance
    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 5mg
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameCrestor 5mg
    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 INNRosuvastatine
    D.3.9.2Current sponsor codeZD4522
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 Tahor 10mg
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameTahor 10mg
    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 INNAtorvastatine
    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: 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 Information not present in EudraCT
    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.3.2Product code Pravastatine
    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 INNPravastatine
    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.8 Information on Placebo
    D.8 Placebo: 1
    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
    Hypercholestérolémies de type IIa et IIb
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10020602
    E.1.2Term Hypercholesteremia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    L’objectif principal de l’étude est de comparer, après 8 semaines de traitement, la variation (en pourcentage des valeurs initiales) du taux de LDL-C de :

    - rosuvastatine 5 mg versus pravastatine 40 mg
    et
    - rosuvastatine 5 mg versus atorvastatine 10 mg.
    E.2.2Secondary objectives of the trial
    Comparer dans les groupes rosuvastatine 5 mg versus pravastatine 40 mg
    et rosuvastatine 5 mg versus atorvastatine 10 mg après 8 semaines de traitement :

    - le pourcentage de patients atteignant l'objectif de LDL-C conformément aux recommandations de l’AFSSAPS 2005 au global et selon le nombre de facteurs de risque (2, plus de 2)

    - la variation des taux de cholestérol total, HDL-C et triglycérides

    - la variation du rapport ApoB/ApoA1

    - la variation de la CRP et du taux de phospholipase A2 (PLA2)

    - le pourcentage de patients atteignant l'objectif de LDL-C conformément aux recommandations américaines (NCEP ATP III) et Européennes (EAS)

    - Evaluer la tolérance clinique et biologique après 8 semaines de traitement par rosuvastatine 5 mg, pravastatine 40 mg ou atorvastatine 10 mg en une prise quotidienne.



    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Pour être inclus dans l’étude, les patients doivent remplir tous les critères suivants :

    1. Patient ayant donné son consentement écrit à sa participation dans cette étude
    2. Patient de sexe masculin ou féminin, âgé de 18 ans ou plus
    3. Patient présentant une hypercholestérolémie primaire de type IIa ou IIb diagnostiquée depuis au moins 3 mois
    4. Patient en prévention primaire avec au moins deux facteurs de risque cardiovasculaire associé
    5. Patient :
    (a) soit « naïf » de tout traitement hypolipémiant, c’est-à-dire non traité depuis au moins 8 semaines par un hypolipémiant quel qu’il soit et sous régime depuis au moins 3 mois ; pour ces patients à partir d’un bilan datant de moins de 3 mois le taux de LDL-C à la visite d’inclusion (V1) doit être supérieur à 1.6 g/l en présence de 2 autres facteurs de risque ou supérieur à 1.3 g/l en présence de plus de 2 autres facteurs de risque,
    (b) soit traité par statine (traitement en cours ou arrêté depuis moins de 8 semaines) en tenant compte du bénéfice apporté au patient par sa participation à l’étude, selon le jugement de l’investigateur. Pour les patients avec un traitement en cours, la statine sera arrêtée à la visite d’inclusion (V1).

    E.4Principal exclusion criteria
    Tous les critères suivants sont des critères d’exclusion de l’étude :
    1. Hypercholestérolémie familiale homozygote ou hétérozygote
    2. Traitement en cours par fibrates et/ou par ézétimibe
    3. Hypertriglycéridémie (taux de TG ≥ 4 g/l)
    4. Patients à haut risque cardiovasculaire selon la définition AFSSAPS 2005 (coronariens ou antécédents de maladie vasculaire avérée, diabétique de type 2 à haut risque cardiovasculaire, patient en prévention primaire avec un score de Framingham > 20 % à 10 ans)
    5. Antécédents d’évènement indésirable ou d’hypersensibilité à un inhibiteur de l’HMG-CoA réductase (en particulier tout antécédent de myopathie)
    6. Hypothyroïdie non contrôlée
    7. Utilisation concomitante de tout médicament interdit pendant la durée de l’étude (voir §3.7, traitements interdits)
    8. Affection hépatique évolutive avec élévation des transaminases sériques (ASAT, ALAT) au-delà de 2 fois la limite supérieure de la normale
    9. CPK au-delà de 3 fois la limite supérieure de la normale
    10. Insuffisance rénale sévère (clairance de la créatinine < 30 ml/min)
    11. Diabète de type I (diabète insulino-dépendant)
    12. Hypertension artérielle non contrôlée (PAD > 95 mmHg et/ou PAS > 180 mmHg)
    13. Femme enceinte ou allaitant ou femme en âge de procréer n’utilisant pas de moyen de contraception approprié selon le jugement de l’investigateur
    14. Troubles médicaux ou psychologiques graves ou instables qui, de l’avis de l’investigateur, risqueraient de mettre en danger la sécurité du patient ou de compromettre sa participation à cette étude
    15. Antécédents d’abus d’alcool ou de drogue durant les 2 années précédentes
    16. Antécédents de tumeur (à moins d’être en période de rémission depuis au moins 5 ans) à l’exception des tumeurs cutanées à cellules basales ou à cellules squameuses
    17. Patient présentant une galactosémie congénitale, ou un syndrome de malabsorption du glucose et du galactose ou un déficit en lactase
    18. Patient participant à un autre essai clinique pendant la durée de l’étude ou ayant participé dans le mois précédant l’inclusion
    19. Patient précédemment inclus dans cette étude et sorti d’essai
    20. Patient impliqué dans l’organisation ou la conduite de l’étude.
    E.5 End points
    E.5.1Primary end point(s)
    Le critère principal de jugement est la variation (en pourcentage des valeurs initiales) du taux de LDL-C après 8 semaines de traitement par rosuvastatine 5 mg ou atorvastatine 10 mg ou pravastatine 40 mg.
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 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.8.4.1Number of sites anticipated in Member State concerned170
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state1150
    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 Decision2007-03-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-03-26
    P. End of Trial
    P.End of Trial StatusOngoing
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