Clinical Trials Register

Summary
EudraCT Number:	2012-001363-70
Sponsor's Protocol Code Number:	20110115
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:	2012-09-25
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

2012-001363-70

A.3

Full title of the trial

A Double-blind, Randomized, Placebo and Ezetimibe Controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 on LDL-C in Combination With Statin Therapy in Subjects With Primary Hypercholesterolemia and Mixed Dyslipidemia

Studio multicentrico, in doppio cieco, randomizzato e controllato con placebo ed ezetimibe per valutare la sicurezza, la tollerabilita' e l'efficacia di AMG 145 in associazione alla terapia con statine nel controllo dell'LDL-C, in soggetti con ipercolesterolemia primaria e dislipidemia mista

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Study to assess the safety and efficacy of AMG-145 on LDL-cholesterol, in combination with Statin therapy in patients with high blood cholesterol or high concentration of lipids in the blood.

Studio per valutare la sicurezza e l'efficacia di AMG145 sul colesterolo-LDL somministrato n combinazione le statine nei pazienti con un alto livello di colesterolo o un'alta concentrazione di lipidi nel sangue

A.4.1

Sponsor's protocol code number

20110115

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	AMGEN INC.
B.1.3.4	Country	United States
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	Amgen Inc
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Amgen Dompe' SpA
B.5.2	Functional name of contact point	Dip.to Regolatorio
B.5.3	Address:
B.5.3.1	Street Address	Via Tazzoli, 6
B.5.3.2	Town/ city	Milano
B.5.3.3	Post code	20154
B.5.3.4	Country	Italy
B.5.4	Telephone number	026241121
B.5.5	Fax number	0229005596
B.5.6	E-mail	gbotta@amgen.com

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	No
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	AMG145
D.3.2	Product code	NA
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	AMG145
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	70
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
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	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
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	Yes
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	ZETIA (ezetimibe) tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck & Co. Inc.
D.2.1.2	Country which granted the Marketing Authorisation	United States
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	No
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	EZETIMIBE
D.3.9.1	CAS number	163222-33-1
D.3.9.4	EV Substance Code	SUB16430MIG
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)	No
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	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
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	No
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	Solution for injection
D.8.4	Route of administration of the placebo	Subcutaneous 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

Primary Hypercholesterolemia and Mixed Dyslipidemia

Ipercolesterolemia primaria e dislipidemia mista

E.1.1.1

Medical condition in easily understood language

Abnormal amounts of lipids in the blood and Elevated level of total cholesterol in the bloodstream

Livelli elevati di lipidi e di colesterolo totale nel sangue

E.1.1.2

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	15.1
E.1.2	Level	PT
E.1.2	Classification code	10058108
E.1.2	Term	Dyslipidaemia
E.1.2	System Organ Class	10027433 - Metabolism and nutrition disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	15.1
E.1.2	Level	LLT
E.1.2	Classification code	10020604
E.1.2	Term	Hypercholesterolemia
E.1.2	System Organ Class	10027433 - Metabolism and nutrition disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the effect of 12 weeks of subcutaneous (SC) AMG 145 administered every 2 weeks (Q2W) and every 4 weeks (Q4W) when used in combination with a statin, compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in subjects with primary hypercholesterolemia and mixed dyslipidemia.

Valutare l'effetto a 12 settimane di AMG 145 somministrato per via sottocutanea (SC) ogni 2 settimane (Q2W) e ogni 4 settimane (Q4W) in associazione a una statina rispetto al placebo, sulla variazione percentuale rispetto al baseline, nel colesterolo della lipoproteina a bassa densità (LDL-C) in soggetti con ipercolesterolemia primaria e dislipidemia mista

E.2.2

Secondary objectives of the trial

• To evaluate the safety and tolerability of SC AMG 145 Q2W and Q4W used in combination with a statin, compared with placebo or ezetimibe, in subjects with primary hypercholesterolemia and mixed dyslipidemia • To assess the effects of 12 weeks of SC AMG 145 Q2W and Q4W used in combination with a statin compared to placebo or ezetimibe, on change from baseline in LDL-C, and percent change from baseline in nonhigh- density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB), total cholesterol/HDL-C ratio, ApoB/ Apolipoprotein A-1 (ApoA1) ratio lipoprotein (a) [Lp(a)], triglycerides and HDLC in subjects with primary hypercholesterolemia and mixed dyslipidemia Please see the Protocol for furhte secondary objectives

Valutare la sicurezza e la tollerabilita` di AMG 145 SC Q2W e Q4W somministrato in associazione a una statina, rispetto a placebo o ezetimibe, in soggetti con ipercolesterolemia primaria e dislipidemia mista -Valutare gli effetti a 12 settimane diAMG 145 SC Q2W e Q4W somministrato in associazione a una statina, rispetto a placebo o ezetimibe, sulla variazione rispetto al basale di LDL-C e sulla variazione percentuale rispetto al basale nel colesterolo della lipoproteina non ad alta densita` (non-HDL-C), nell`apolipoproteina B (ApoB), nel rapporto colesterolo totale/HDL-C, nel rapporto ApoB/Apolipoproteina A-1 (ApoA1), nella lipoproteina(a) (Lp[a]), nei trigliceridi e nell`HDL-C in soggetti con ipercolesterolemia primaria e dislipidemia mista Si veda il protocollo per ulteriori Obiettivi secondari

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

PHARMACOGENETIC:
Vers:--
Date:2012/04/05
Title:Pharmacogenetic Studies (Protocol Section 7.4.2)
Objectives:The optional pharmacogenetic analyses focus on inherited genetic variations such as those of the PCSK9 gene or the LDLR gene to evaluate their possible correlation to the disease and/or responsiveness to the therapies
used in this study.

FARMACOGENETICA:
Vers:--
Data:2012/04/05
Titolo:Studio Farmacogenetico (Sez. 7.4.2 del protocollo)
Obiettivi:Le analisi farmacogenetiche opzionali si concentreranno su varianti genetiche ereditarie, quali quelle del gene PCSK9 o il gene LDLR per valutare la loro possibile correlazione alla patologia e/o la risposta alle terapie
utilizzate in questo studio

E.3

Principal inclusion criteria

• Male or female ≥ 18 to ≤ 80 years of age • Subjects not taking a statin at screening must have a fasting LDL-C of at least 150 mg/dl (4.0 mmol/L) as determined by central laboratory • Subjects already on a non-intensive statin (see Appendix D) at screening must have a fasting LDL-C at screening of ≥ 100 mg/dL (2.6 mmol/L) as determined by central laboratory • Subjects already on a intensive statin (see Appendix D) at screening must have a fasting LDL-C at screening of ≥ 80 mg/dL (2.1 mmol/L) as determined by central laboratory • Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L) by central laboratory at screening

• maschi o femmine tra 18 e 80 anni di età • soggetti che non assumevano una statina al momento dello screening devono avere un LDL-Ca digiuno di almeno 150 mg / dl (4,0 mmol / L), come determinato dal laboratorio centrale • Soggetti già trattamento non intensivo con statine (vedi Appendice D) allo screening devono avere un LDL-C a digiuno al momento dello screening di ≥ 100 mg / dl (2,6 mmol / L) come determinato dal laboratorio centrale • I soggetti già in terapia intensiva con statina (vedi Appendice D) allo screening devono avere un LDL-C a digiuno al momento dello screening di ≥ 80 mg / dl (2.1 mmol / L) determinato dal laboratorio centrale • trigliceridi a digiuno ≤ 400 mg / dl (4,5 mmol / L) allo screening determinato dal laboratorio centrale

E.4

Principal exclusion criteria

•Current or prior history of statin intolerance, or any intolerance to rosuvastatin, atorvastatin, or simvastatin. •NYHA III or IV heart failure, or last known left ventricular ejection fraction < 30% •Uncontrolled serious cardiac arrhythmia defined as recurrent and highly symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular response, or supraventricular tachycardia that are not controlled by medications, in the past 3 months prior to randomization •Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 6 months prior to randomization •Planned cardiac surgery or revascularization •Type 1 diabetes, poorly controlled type 2 diabetes (HbA1c > 8.5%), newly diagnosed type 2 diabetes (within 6 months of randomization), or laboratory evidence of diabetes during screening (fasting plasma glucose ≥ 126 mg/dL [7.0 mmol/L] or HbA1c ≥ 6.5%) without prior diagnosis of diabetes •Uncontrolled hypertension defined as sitting systolic blood pressure (SBP) > 160 mmHg or diastolic BP (DBP) > 100 mmHg •Subject has taken in the last 6 weeks prior to LDL‑C screening red yeast rice, > 200 mg/day niacin, > 1000 mg/day omega-3 fatty acids ( DHA and EPA combined), stanols or prescription lipid-regulating drugs (eg, bileacid sequestering resins, fibrates and derivatives) other than statins and ezetimibe - Subject, who in the opinion of the investigator, requires maximal statin therapy - Personal or family history of hereditary muscular disorders - Known sensitivity to any of the active substances or their excipients to be administered during dosing. Please see the protocol for furtehr exclusion criteria

• Storia pregressa o in corso di intolleranza a statine, o di qualsiasi intolleranza a rosuvastatina, atorvastatina, simvastatina. • insufficienza cardiaca di grado NYHA III o IV, o ultima frazione di eiezione ventricolare sinistra nota <30% • aritmie cardiache grave incontrollata definita come ricorrente e tachicardia ventricolare altamente sintomatica, fibrillazione atriale con rapida risposta ventricolare, o tachicardia sopraventricolare che non sono controllata da farmaci, negli ultimi 3 mesi prima della randomizzazione • Infarto del miocardio, angina instabile, intervento coronarico percutaneo (PCI), intervento di bypass coronarico arterioso (CABG) o ictus nei 6 mesi prima della randomizzazione • intervento chirurgico programmato cardiaco o rivascolarizzazione • diabete di tipo 1, diabete di tipo 2 scarsamente controllato (HbA1c> 8,5%), nuova diagnosi di diabete di tipo 2 (entro 6 mesi dalla randomizzazione), o prove di laboratorio di diabete durante lo screening (plasma a digiuno glicemia ≥ 126 mg / dL [7.0 mmol / L] o HbA1c ≥ 6,5%) in assenza di preventiva diagnosi di diabete • ipertensione non controllata definita come pressione arteriosa sistolica da seduto (SBP)> 160 mmHg o pressione arteriosa diastolica (DBP)> 100 mmHg • Il soggetto ha assunto negli ultimi 6 settimane prima dello screening LDL-C lievito di riso rosso, niacina > 200 mg / die, acidi grassi omega-3 > 1000 mg / al giorno ( DHA e EPA combinati), stanoli o farmaci da prescrizione regolatori del lipidi (ad esempio, resine sequestranti acidi biliari, fibrati e derivati) diversi da statine ed ezetimibe - soggetti che necessitano di una dose massima di statine - storia famigliare o personale di disordini scheletrici ereditari - comprovata sensibilità verso la sostanza attiva o suoi eccipienti. Si veda il protocollo per gli ulteriori criteri di esclusione.

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is the percent change from baseline in LDL-C at week 12.

L'endpoint primario è la percentuale di variazione dell’LDL-C alla settimana 12, rispetto al basale

E.5.1.1

Timepoint(s) of evaluation of this end point

At week 12

Settimana 12

E.5.2

Secondary end point(s)

Tier 1 endpoints • Change from baseline in LDL-C at week 12 • LDL-C response (LDL-C < 70 mg/dL [1.8 mmol/L]) at week 12 • Percent change from baseline in non-HDL-C at week 12 • Percent change from baseline in ApoB at week 12 • Percent change from baseline in the total cholesterol/HDL-C ratio at week 12 • Percent change from baseline in ApoB/ApoA1 ratio at week 12 Tier 2 endpoints • Percent change from baseline in Lp(a) at week 12 • Percent change from baseline in triglycerides at week 12

Livello 1 -Variazione dal baseline alla settimana 12 nell'LDL-C -Risposta dell'LDL-C (LDL-C < 70 mg/dl [1,8 mmol/l]) alla settimana 12 -Percentuale di variazione dal baseline alla settimana 12 nel non-HDL-C -Percentuale di variazione dal baseline alla settimana 12 nella ApoB -Percentuale di variazione dal baseline alla settimana 12 nel rapporto colesterolo totale/HDL-C -Percentuale di variazione dal baseline alla settimana 12 nel rapporto ApoB/ApoA1 Livello 2 -Percentuale di variazione dal baseline alla settimana 12 nella Lp(a) -Percentuale di variazione dal baseline alla settimana 12 nei trigliceridi -Percentuale di variazione dal baseline alla settimana 12 nell'HDL-C

E.5.2.1

Timepoint(s) of evaluation of this end point

Secondary Efficacy Endpoints • Change from baseline in LDL-C at week 12 • LDL-C response (LDL-C < 70 mg/dL [1.8 mmol/L]) at week 12 • Percent change from baseline in non-HDL-C at week 12 • Percent change from baseline in ApoB at week 12 • Percent change from baseline in the total cholesterol/HDL-C ratio at week 12 • Percent change from baseline in ApoB/ApoA1 ratio at week 12 • Percent change from baseline in Lp(a) at week 12 • Percent change from baseline in triglycerides at week 12

Variazione dal baseline alla settimana 12 nell'LDL-C -Risposta dell'LDL-C (LDL-C < 70 mg/dl [1,8 mmol/l]) alla settimana 12 -Percentuale di variazione dal baseline alla settimana 12 nel non-HDL-C -Percentuale di variazione dal baseline alla settimana 12 nella ApoB -Percentuale di variazione dal baseline alla settimana 12 nel rapporto colesterolo totale/HDL-C -Percentuale di variazione dal baseline alla settimana 12 nel rapporto ApoB/ApoA1 Livello 2 -Percentuale di variazione dal baseline alla settimana 12 nella Lp(a) -Percentuale di variazione dal baseline alla settimana 12 nei trigliceridi -Percentuale di variazione dal baseline alla settimana 12 nell'HDL-C

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

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

biomarker development

sviluppo biomarker

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

Yes

E.8.2.3.1

Comparator description

ezetimibe

E.8.2.4

Number of treatment arms in the trial

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

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

110

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

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

Argentina

Australia

Brazil

Canada

Hong Kong

Korea, Democratic People's Republic of

Mexico

Russian Federation

South Africa

Switzerland

Taiwan

United States

E.8.7

Trial has a data monitoring committee

Yes

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

The end of the study for this trial is defined as the date on which the
last randomized subject has had the opportunity to complete their EOS
assessment. This will occur at the week 12 assessment for subjects
randomized to the Q4W treatment arm or at the week 14 assessment
for subjects randomized to the Q2W treatment arm).

E' la data in cui l'ultimo soggetto randomizzato ha avuto la possibilità di completare la valutazione di EoS. Questo accadrà alla sett. 12 per i soggetti randomizzati al braccio di trattamento Q4W o alla sett. 14 per quelli del braccio Q2W.

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

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

1300

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

400

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

750

F.4.2.2

In the whole clinical trial

1700

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)

Subjects may be eligible for continued treatment with Amgen IP by an
extension protocol or as provided for by the local country's regulatory
mechanism. However, Amgen reserves the unilateral right, at its sole
discretion, to determine whether to supply Amgen IP, and by what
mechanism, after termination of the trial and before it is available
commercially.

I soggetti potrebbero beneficiare di un trattamento continuato con l'IMP tramite un protocollo di estensione o se previsto dalla normativa del paese. Tuttavia, Amgen si riserva il diritto unilaterale, a sua esclusiva discrezione, se fornire l'IMP, e con quale modalità, dopo il termine dello studio e prima che l'IMP sia disponibile commercialmente

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

2012-08-05

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-09-13

P. End of Trial
P.	End of Trial Status	Completed

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
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IMP with orphan designation in the indication
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