Clinical Trials Register

Summary
EudraCT Number:	2005-002892-34
Sponsor's Protocol Code Number:	D3560L00052
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2006-10-11
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2005-002892-34

A.3

Full title of the trial

Comparison of the Effects Noted in The ApoB/ApoA-I ratio Using Rosuvastatin and atorvastatin in patients with acUte coronary Syndrome

A.3.2

Name or abbreviated title of the trial where available

CENTAURUS STUDY

A.4.1

Sponsor's protocol code number

D3560L00052

A.5.1

ISRCTN (International Standard Randomised Controlled Trial) Number

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
B.1.3.4	Country	Italy
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*28CPR RIV 20MG
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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.3.4	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	Rosuvastatin
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	Information not present in EudraCT
D.3.11.8	Extractive medicinal product	Information not present in EudraCT
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	LIPITOR 40*10CPR 40MG
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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.3.4	Pharmaceutical form	Capsule, hard
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	Atorvastatin
D.3.9.1	CAS number	134523-03-8
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	40
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	Information not present in EudraCT
D.3.11.8	Extractive medicinal product	Information not present in EudraCT
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	Tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, hard
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

Acute Coronary Syndrome

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	6.1
E.1.2	Level	PT
E.1.2	Classification code	10051592

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Compare the efficacy of rosuvastatin 20 mg versus atorvastatin 80 mg in reducing ApoB/ApoA-I ratio at 3 months in acute coronary syndrome ACS patients receiving the study treatment after a PCI.

E.2.2

Secondary objectives of the trial

1.The efficacy of rosuvastatin 20 mg versus atorvastatin 80 mg in reducing the LDL-C level at 1 month and 3 months in patients receiving the study treatment after a PCI 2.The efficacy of early started rosuvastatin 20 mg versus placebo on hs-CRP from the admission of patients Day 6 until start of study treatment after the PCI Day 0 . 3.The efficacy of rosuvastatin 20 mg versus atorvastatin 80 mg in reducing ApoB/ApoA-I ratio at 1 month in patients receiving the study treatment after a PCI

E.2.3

Trial contains a sub-study

Information not present in EudraCT

E.3

Principal inclusion criteria

1.Provision of written informed consent. 2.Men or women who are 18 and 75 years old. 3.Hospital admission for ACS with chest pain or discomfort occurring during rest or with minimal exertion, relieved by nitroglycerin or lasting for at least 15 minutes if untreated, and with the most recent occurrence 24 hours before hospital admission 4.Percutaneous coronary intervention PCI planned 5.In addition to ischemic symptoms, patients must have evidence of coronary artery disease.

E.4

Principal exclusion criteria

1.History of statin induced myopathy, or serious or hypersensitivity reaction to other HMG-CoA reductase inhibitors statins . 2.Known homozygous familial hypercholesterolemia. 3.Any cholesterol lowering medication HMG-CoA reductase inhibitors, fibrates, niacin 400 mg/day , ezetimibe, bile acid sequestrants, probucol or other prescription medications used to treat dyslipidemia Table 4 taken within 1 month prior to the Visit 1. Patients taking lipid lowering dietary supplements, anti-oxidants, or food additives may continue at their current dose. No new lipid lowering dietary supplements, anti-oxidants or food additives should be started for the duration of the study. 4.Pregnant women, women who are breast-feeding, and women of childbearing potential who are not using chemical or mechanical contraception, or who have a positive serum pregnancy test serum b-HCG . 5.Sustained ST-segment elevation on 12-lead ECG 6.Active liver disease or hepatic dysfunction or alanine aminotransferase ALT elevation of 2 x ULN 7.Serum creatinine 2.0 mg/dL 176 mmol/L . 8.LDL-C 40 mg/dL 1.03 mmol/L or triglycerides 400 mg/dL 4.52 mmol/L 9.Patients whose hormone replacement therapy HRT or oral contraceptive therapy OCT was initiated within the 3 months prior to the Visit 1. 10.History of malignancy unless a documented disease-free period exceeding 5 years is present with the exception of basal cell or squamous cell carcinoma of the skin. Women with a history of cervical dysplasia would be permitted to enter the study provided they have 3 consecutive clear Papanicolaou Pap smears 11.Use of concomitant medications, as detailed in Table 4. 12.History of alcohol and/or drug abuse within the past 5 years. 13.Creatine kinase CK 3 x ULN and myocardial isoenzymes CK-MB 2 x ULN at Visit 1. If CK-MB is not available, should be considered CK 3 x ULN and Cardiac Troponin I or T 0 at Visit 1. 14.Systolic hypotension systolic blood pressure SBP 90 mmHg or poorly controlled hypertension SBP 200 mmHg or diastolic blood pressure 110 mmHg recorded since the onset of symptoms. 15.Planned therapeutic coronary intervention other than primary PCI or bypass surgery during the current hospitalization. 16.CABG or percutaneous coronary intervention PCI within the 3 months prior to Visit 1. 17.Occurrence of ventricular fibrillation, sustained ventricular tachycardia, complete heart block, new onset of fibrillation with uncontrolled ventricular rate 100 bpm , or paced ventricular rhythm within the preceding 4 weeks of Visit 1. 18.Stroke, sepsis, acute pericarditis, or any evidence of systemic or pulmonary embolus within the preceding 4 weeks of Visit 1. 19.Known uncontrolled hypothyroidism defined as a thyroid stimulating hormone TSH 1.5 times the upper limit of normal ULN at Visit 1 20.Severe or uncontrolled diabetes Type I or II according to the investigator s judgement. 21.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. 22.Participation in another investigational drug study and/or having ingested investigational drug 61603; 61472;4 weeks, or according to local ethics committee requirements where a larger period is stipulated. 23.Patients already enrolled in the present study. 24.Involvement in the planning and conduct of the study applies to both AstraZeneca staff or staff at the study site

E.5 End points

E.5.1

Primary end point(s)

Death Non Fatal Myocardial Infarction Non fatal Stroke Unstable Angina Repeat Revascularization

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

Information not present in EudraCT

E.6.9

Dose response

E.6.10

Pharmacogenetic

Information not present in EudraCT

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Information not present in EudraCT

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

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

Yes

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.8.5

The trial involves multiple Member States

Yes

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

E.8.7

Trial has a data monitoring committee

Information not present in EudraCT

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

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
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	Information not present in EudraCT
F.3.3.1	Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-10-11.	Yes
F.3.3.2	Women of child-bearing potential using contraception	Information not present in EudraCT
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	Yes
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	100
F.4.2	For a multinational trial
F.4.2.1	In the EEA	575
F.4.2.2	In the whole clinical trial	1075

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

2006-06-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2006-03-28

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2007-10-06

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