Clinical Trials Register

Summary
EudraCT Number:	2013-000239-28
Sponsor's Protocol Code Number:	D1693C00001
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:	2013-05-14
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

2013-000239-28

A.3

Full title of the trial

DECLARE Dapagliflozin Effect on CardiovascuLAR Events
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Dapagliflozin 10 mg Once Daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischemic Stroke in Patients with Type 2 Diabetes

Studio multicentrico, randomizzato, in doppio cieco, controllato vs placebo per valutare gli effetti di dapaglifozin 10 mg una volta al giorno sull’incidenza della morte per cause cardiovascolari, infarto del miocardio o ictus ischemico in pazienti con diabete di tipo 2.

A.3.1

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

Multicenter Trial to Evaluate the Effect of Dapaglliflozin on the Incidence of Cardiovascular Events (DECLARE)

Studio Multicentrico per valutare l'effeto di dapaglifozin sull'incidenza degli eventi cardiovascolari (DECLARE)

A.3.2

Name or abbreviated title of the trial where available

DECLARE

A.4.1

Sponsor's protocol code number

D1693C00001

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01730534

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

P/207/2012

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	AstraZeneca AB
B.1.3.4	Country	Sweden
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	AstraZeneca AB
B.4.2	Country	Sweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	AstraZeneca
B.5.2	Functional name of contact point	Information Center
B.5.3	Address:
B.5.3.1	Street Address	1800 Concord Pike, PO Box 15437
B.5.3.2	Town/ city	Wilmington
B.5.3.3	Post code	19850-5437
B.5.3.4	Country	United States
B.5.4	Telephone number	001800236993
B.5.6	E-mail	information.center@astrazeneca.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	Yes
D.2.1.1.1	Trade name	Forxiga
D.2.1.1.2	Name of the Marketing Authorisation holder	AstraZeneca AB
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	Dapagliflozin
D.3.2	Product code	BMS-512148
D.3.4	Pharmaceutical form	Film-coated tablet
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	dapaglifozin
D.3.9.1	CAS number	960404-48-2
D.3.9.2	Current sponsor code	BMS-512148-05
D.3.9.3	Other descriptive name	DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE
D.3.9.4	EV Substance Code	SUB90205
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	Film-coated tablet
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

Type II Diabetes mellitus

Diabete mellito di tipo II

E.1.1.1

Medical condition in easily understood language

Diabetes Type II

Diabete di tipo II

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	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10012613
E.1.2	Term	Diabetes mellitus non-insulin-dependent
E.1.2	System Organ Class	100000004861

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary efficacy objective is to determine whether treatment with dapagliflozin compared with placebo when added to current background therapy will result in a reduction in the incidence of the composite endpoint of cardiovascular death, myocardial infarction (MI), or ischemic stroke in patients with type 2 diabetes mellitus (T2DM) with either established cardiovascular disease or at least two cardiovascular risk factors in addition to T2DM.

L'obiettivo primario di efficacia è determinare se il trattamento con dapagliflozin rispetto a placebo quando aggiunto alla terapia corrente comporta una riduzione dell’incidenza dell'endpoint composito di morte cardiovascolare, infarto del miocardio (MI), o ictus ischemico nei pazienti con diabete di tipo 2 e con una malattia cardiovascolare nota o con almeno due fattori di rischio cardiovascolare in aggiunta al diabete mellito di tipo 2.

E.2.2

Secondary objectives of the trial

The secondary objective is to determine whether treatment with dapagliflozin compared with placebo when added to current background therapy in patients with T2DM with either established cardiovascular disease or at least two cardiovascular risk factors in addition to T2DM will result in a reduction of:
· Hospitalization for Congestive Heart Failure
·The composite endpoint of cardiovascular death, MI, ischemic stroke, hospitalization for heart failure, hospitalization for unstable angina pectoris, or hospitalization for any revascularization.
· All-cause mortality
· Body weight from baseline

L'obiettivo secondario di efficacia è di determinare se il trattamento con dapaglifozin confrontato con placebo in aggiunta alla terapia standard in pazienti con diabete mellito di tipo 2 con una malattia cardiovascolare nota o con almeno due fattori di rischio cardiovascolare oltre al diabete porterà a una riduzione:
•dei ricoveri per insufficienza cardiaca congestizia
•dell’endpoint composito di morte cardiovascolare, infarto del miocardio, ictus ischemico, ospedalizzazione per insufficienza cardiaca, ospedalizzazione per angina pectoris instabile o ospedalizzazione per rivascolarizzazione
•della mortalità per qualsiasi causa
•del peso corporeo rispetto al baseline

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

For inclusion in the study patients should fulfill the following criteria:
1. Provision of informed consent prior to any study specific procedures (including run-in)
2. Female or male aged ≥ 40 years
3. Diagnosed with T2DM (See Appendix E for details)
4. High Risk for CV event defined as having either established CV disease and/or multiple risk factors:
- Established CV Disease (See Appendix E for details)
OR
No known cardiovascular disease AND at least two cardiovascular risk factors in addition to T2DM, defined as:
- Age > 55 years in men and > 60 in women
AND presence of at least 1 of the following additional risk factors (see Appendix E for details)
- Dyslipidemia
- Hypertension
- Tobacco use

5. WOCBP must take precautions to avoid pregnancy throughout the study and for 4 weeks after intake of the last dose.
- WOCBP must have a negative urine pregnancy test. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal.
- WOCBP must be willing to use a medically accepted method of contraception that is considered reliable in the judgment of the Investigator.
For inclusion in the optional genetic research, patients must fulfill the criterion specified in Appendix H.

Per l'inclusione nello studio i pazienti devono soddisfare i seguenti criteri:
1.Firma del consenso informato prima di qualsiasi procedura studio-specifica (compreso il run-in)
2.Maschi o femmine di età ≥ 40 anni
3.Diagnosi di diabete mellito di tipo 2
4.Alto rischio per eventi cardiovascolari definito come una malattia cardiovascolare ben definita e/o multipli fattori di rischio:
- malattia cardiovascolare ben definita o
nessuna malattia cardiovascolare nota E almeno due fattori di rischio oltre al diabete mellito definiti come:
-età >55 anni per gli uomini e >60 anni per le donne
E
La presenza di almeno uno dei seguenti fattori di rischio aggiuntivi:
-Dislipidemia
-Ipertensione
-Uso di tabacco
5. Le donne in età fertile devono impegnarsi ad evitare gravidanze durante lo studio e per 4 settimane dopo l’assunzione dell’ultima dose
-Le donne in età fertile devono avere un test di gravidanza effettuato sulle urine
Negativo. Per donna in età fertile si intende qualsiasi donna che abbia il ciclo
mestruale e che non sia stata sottoposta a sterilizzazione chirurgica (isterectomia,legame delle tube o ooforectomia bilaterale) o che non è in postmenopausa.
- Le donne in età fertile devono essere disposte ad utilizzare un metodo di
contraccezione che sia giudicato efficace dallo Sperimentatore.

Per l'inclusione nella parte di ricerca genetica dello studio i pazienti devono soddisfare i criteri indicati nell'Appendice H

E.4

Principal exclusion criteria

1. Use of the following excluded medications:
- Current or recent (within 24 months) treatment with pioglitazone and/or use of pioglitazone for 2 years or more at any time
- Current or recent (within 12 months) treatment with rosiglitazone
- Previous treatment with any SGLT2 inhibitor
- Any patient currently receiving chronic (>30 consecutive days) treatment with an oral steroid at a dose equivalent to oral prednisolone ≥10 mg (e.g., betamethasone ≥1.2 mg, dexamethasone ≥1.5 mg, hydrocortisone ≥40 mg) per day
2. Acute cardiovascular event[e.g., acute coronary syndrome (ACS), transient ischemic attack (TIA), stroke, any revascularization, decompensated HF, sustained tachycardia <8 weeks prior to randomization. Patients with acute cardiovascular events can be enrolled in the run-in period as long as randomization does not occur within 8 weeks of the event.
3. Systolic BP >180 or diastolic BP >100 mmHg at randomization
4. Diagnosis of Type 1 diabetes mellitus, MODY, or secondary diabetes mellitus
5. History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time
6. History of any other malignancy within 5 years (with the exception of successfully treated non-melanoma skin cancers)
7. Chronic cystitis and/or recurrent urinary tract infections (3 or more in the last year)
8. Any conditions that, in the opinion of the Investigator, may render the patient unable to complete the study including but not limited to cardiovascular (NYHA class IV CHF, recurrent ventricular arrhythmias) or non-cardiovascular disease (e.g., active malignancy with the exception of basal cell carcinoma, cirrhosis, chronic lung disease, severe autoimmune disease) and/or a likely fatal outcome within 5 years
9. Pregnant or breast-feeding patients
10. Involvement in the planning and/or conduct of the study or other dapagliflozin studies (applies to AZ, BMS, Hadassah and Thrombolysis in Myocardial Infarction [TIMI] or representative staff and/or staff at the study site)
11. Previous randomization in the present study
12. Active participation in another clinical study with IP and/or investigational device
13. Individuals at risk for poor protocol or medication compliance during run-in period (reasonable compliance defined as 80 – 120%, unless a reason for non-compliance is judged acceptable by the Investigator). If for any reason, the Investigator believes that the patient will not tolerate or be compliant with IP or study procedures, the patient should not be randomized and considered a run-in failure.
Patients will be excluded during run-in and should not be randomized if the following are observed from laboratory or observation during enrollment and run-in assessments:
14. HbA1c ≥12% or HbA1c<6.5%
15. AST or ALT >3x ULN or Total bilirubin >2.5 x ULN
16. CrCl < 60 ml/min (based on the Cockroft-Gault equation)
17. Hematuria (confirmed by microscopy at Visit 1) with no explanation as judged by the Investigator up to randomization. If bladder cancer is identified, patients are not eligible to participate.
18. Any reason the Investigator believes the patient is not likely to be compliant with the study medication and protocol.
Exclusion criteria for the optional genetic research
The exclusion criteria for the optional genetic research are provided in Appendix H.

1.Trattamento con uno dei seguenti farmaci:

•Attuale o recente (entro 24 mesi) trattamento con pioglitazione e/o uso di pioglitazione per 2 anni o più in qualsiasi momento della vita

•Attuale o recente (entro 12 mesi) trattamento con rosiglitazone

•Precedente trattamento con inibitori di trasportatori sodio/glucosio SGLT2

•Pazienti attualmente in trattamento cronico (>30 giorni consecutivi) con uno steroide orale ad un dosaggio equivalente al prednisolone orale ≥10 mg al giorno (cioè betametasone ≥1.2 mg, dexametasone ≥1.5 mg, idrocortisone ≥40 mg)
2.Evento cardiovascolare acuto (sindrome coronarica acuta (ACS), attacco ischemico transitorio (TIA), ictus, qualsiasi rivascolarizzazione, insufficienza cardiaca scompensata, tachicardia sostenuta nelle 8 settimane prima della randomizzazione). I pazienti con eventi cardiovascolari acuti possono essere arruolati nel periodo di run-in a patto che la randomizzazione avvenga dopo 8 settimane dall’evento.

3.Pressione sanguigna sistolica >180 e diastolica >100 mmHg alla randomizzazione.

4.Diagnosi di diabete mellito di tipo 1, diabete giovanile ad insorgenza adulta (MODY) o diabete mellito secondario.

5.Storia di tumore della vescica o storia di trattamento con radiazioni nel basso addome o pelvi in qualsiasi momento della vita.

6.Storia di qualsiasi altro tumore maligno nei 5 anni prima dello studio (ad eccetto dei tumori della pelle non melanomi trattati con successo).

7.Cistite cronica e/o infezioni ricorrenti del tratto urinario ( 3 o più nell’ultimo anno)

8.Qualsiasi condizione che a giudizio dello sperimentatore possa rendere il paziente impossibilitato a completare lo studio includendo ma non limitatamente a malattie cardiovascolari (NYHA classe IV CHF, aritmia ventricolare ricorrente) o non cardiovascolari (tumori maligni in atto ad accezione dei tumori del carcinoma basale, cirrosi, malattia polmonare cronica, severe malattie autoimmuni) e/o con outcome fatale entro i 5 anni

9.Pazienti in gravidanza o allattamento.

10.Coinvolgimento della progettazione e/o conduzione dello studio o di altri studi con dapaglifozin (si applica ad AZ, BMS, Hadassah e gruppo TIMI o staff rappresentativi e/o staff del centro sperimentale.)

11.Precedente randomizzazione nello studio

12.Attiva partecipazione in un altro studio clinico con un prodotto sperimentale e/o un dispositivo medico.

13.Individui a rischio di poca complianza al protocollo o al farmaco nel periodo di run-in (complianza ragionevole definita come 80-120%, a meno che una motivazione della non complianza sia accettata dallo Sperimentatore). Se per qualsiasi ragione lo Sperimentatore pensa che il paziente non tollererà o non sarà compliante al farmaco ed alle procedure di studio il paziente non dovrebbe essere arruolato nello studio e dovrebbe essere considerato un “run-in failure”.

I pazienti saranno esclusi durante il periodo di run-in e non dovrebbero essere randomizzati se si dovessero riscontrare i seguenti valori di laboratorio all’arruolamento o durante il periodo di run-in:

14. HbA1c ≥12% o HbA1c<6.5%

15. AST or ALT >3x ULN o Bilirubina Totale >2.5 x ULN

16. CrCl < 60 ml/min (basato sull’equazione di Cockroft-Gault)

17.Ematuria (confermata da microscopia a visita 1) senza apparente motivo a giudizio dello Sperimentatore prima della randomizzazione. Se viene identificato tumore della vescica il paziente non può partecipare.

18.Qualsiasi motivo per cui lo Sperimentatore ritenga che il paziente non sarebbe compliante all’assunzione del farmaco in studio e alle procedure del protocollo.

Criteri di esclusione per la ricerca genetica opzionale:
I criteri di esclusione per la ricerca genetica opzionale sono specificati nell'Appendice H

E.5 End points

E.5.1

Primary end point(s)

The primary outcome efficacy variable of the study is the composite endpoint of cardiovascular death, myocardial infarction, or ischemic stroke (time to first event). These events will be adjudicated.

La principale variabile di efficacia esito dello studio è l'endpoint composito di morte cardiovascolare morte, infarto miocardico, o ictus ischemico (tempo al primo evento). Questi eventi saranno aggiudicati.

E.5.1.1

Timepoint(s) of evaluation of this end point

This is event triggered and will be evaluated at 1/3 of primary events, 2/3 of primary events and when we have 100% of the primary events, which means at 463, 927 and 1390 primary events

Questo evento sarà raggiunto quando saranno valutati 1/3 degli eventi primari, 2/3 degli eventi primari e quando si sarà raggiunto il 100% degli eventi primari, che significa a 463, 927 e 1390 eventi primari

E.5.2

Secondary end point(s)

The secondary objective is to determine whether treatment with dapagliflozin compared with placebo when added to current background therapy in patients with T2DM with either established cardiovascular disease or at least two cardiovascular risk factors in addition to T2DM will result in a reduction of:
· Hospitalization for Congestive Heart Failure
· The composite endpoint of cardiovascular death, MI, ischemic stroke, hospitalization for heart failure, hospitalization for unstable angina pectoris, or hospitalization for any revascularization.
· All-cause mortality
· Body weight from baseline

L'obiettivo secondario di efficacia è di determinare se il trattamento con dapaglifozin confrontato con placebo in aggiunta alla terapia standard in pazienti con diabete mellito di tipo 2 con una malattia cardiovascolare nota o con almeno due fattori di rischio cardiovascolare oltre al diabete porterà a una riduzione:
-ricovero per insufficienza cardiaca congestizia
-l'endpoint composito di morte cardiovascolare, infarto miocardico, ictus ischemico, ricovero per insufficienza cardiaca, ricovero per angina pectoris instabile o ricovero per rivascolarizzazione
-mortalità per qualsiasi causa
-variazione del peso corporeo dal baseline

E.5.2.1

Timepoint(s) of evaluation of this end point

Secondary endpoints will only be evaluated once – and that is when the study stops. It could be when we have 1/3 of primary events OR when we have 2/3 of primary events OR when we have all primary events.

Gli endpoints secondari saranno valutati una sola volta- e cioè a fine studio. Ciò potrebbe avvenire quando si raggiunge 1/3 degli eventi primari o quando si raggiunge 2/3 degli eventi primari o quando si raggiungono tutti.

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

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)

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)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

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

265

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

Bulgaria

Canada

China

Czech Republic

France

Germany

India

Israel

Italy

Japan

Korea, Republic of

Mexico

Netherlands

Philippines

Poland

Romania

Russian Federation

Slovakia

South Africa

Spain

Sweden

Taiwan

Thailand

Turkey

Ukraine

United Kingdom

United States

Vietnam

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 is defined as ‘the last visit of the last patient undergoing the study’.

La fine dello studio è definita come "LSLV".

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

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

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:

8575

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

8575

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

340

F.4.2

For a multinational trial

F.4.2.1

In the EEA

5440

F.4.2.2

In the whole clinical trial

17150

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)

Background medication and post-study treatment will not be provided by the Sponsor.

I farmaci di background e i trattamenti da assumere dopo la fine dello studio non saranno forniti dallo Sponsor

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

2013-05-30

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-06-20

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-09-16

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Clinical trials