Clinical Trials Register

Summary
EudraCT Number:	2006-006697-15
Sponsor's Protocol Code Number:	D3560L00068
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
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

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A. Protocol Information

A.1

Member State Concerned

France - ANSM

A.2

EudraCT number

2006-006697-15

A.3

Full 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.4.1

Sponsor's protocol code number

D3560L00068

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	AstraZeneca SAS
B.1.3.4	Country	France
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Crestor 5mg
D.2.1.1.2	Name of the Marketing Authorisation holder	AstraZeneca
D.2.1.2	Country which granted the Marketing Authorisation	France
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Crestor 5mg
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Rosuvastatine
D.3.9.2	Current sponsor code	ZD4522
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Tahor 10mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer
D.2.1.2	Country which granted the Marketing Authorisation	France
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Tahor 10mg
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Atorvastatine
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Information not present in EudraCT
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.2	Product code	Pravastatine
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pravastatine
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule*
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Hypercholestérolémies de type IIa et IIb

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	LLT
E.1.2	Classification code	10020602
E.1.2	Term	Hypercholesteremia

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main 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.2.2

Secondary 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.2.3

Trial contains a sub-study

E.3

Principal 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.4

Principal 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.5.1

Primary 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.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

Information not present in EudraCT

E.7.1.2

Bioequivalence study

Information not present in EudraCT

E.7.1.3

Other

Information not present in EudraCT

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

170

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

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.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1.1	In Utero	Information not present in EudraCT
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	Information not present in EudraCT
F.1.1.3	Newborns (0-27 days)	Information not present in EudraCT
F.1.1.4	Infants and toddlers (28 days-23 months)	Information not present in EudraCT
F.1.1.5	Children (2-11years)	Information not present in EudraCT
F.1.1.6	Adolescents (12-17 years)	Information not present in EudraCT
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	1150

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2007-03-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2007-03-26

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2008-10-01

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