Clinical Trials Register

Summary
EudraCT Number:	2009-018173-31
Sponsor's Protocol Code Number:	POISE-2Trial
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:	2010-02-15
Trial 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

2009-018173-31

A.3

Full title of the trial

A large, international, placebo-controlled, factorial trial to assess the impact of clonidine and acetyl-salicylic acid (ASA) in patients undergoing noncardiac surgery who are at risk of a perioperative cardiovascular event.

Studio prospettico,randomizzato multicentrico, internazionale, farmacologico vs placebo, volto a valutare l'impatto della clonidina e dell'acido acetilsalicilico (ASA) in pazienti sottoposti a chirurgia non cardiaca a rischio per eventi cardiovascolari nel perioperatorio.

A.4.1

Sponsor's protocol code number

POISE-2Trial

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	POPULATION HEART RESEARCH INSTITUTE (PHRI)
B.1.3.4	Country	Canada
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	nessun finanziamento
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Fondazione San Raffaele del Monte Tabor
B.5.2	Functional name of contact point	Anest. e Rianim. Cardiotoracovasc.
B.5.3	Address:
B.5.3.1	Street Address	via Olgettina,60
B.5.3.2	Town/ city	milano
B.5.3.3	Post code	20132
B.5.3.4	Country	Italy
B.5.4	Telephone number	02.26437176
B.5.5	Fax number	02.26437178
B.5.6	E-mail	landoni.giovanni@hsr.it

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	ASPIRINA
D.2.1.1.2	Name of the Marketing Authorisation holder	BAYER SpA
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	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	Salicylic acid and derivatives
D.3.9.1	CAS number	50-78-2
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.3	Concentration number	100
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	Yes
D.3.11.13.1	Other medicinal product type	di natura chimica
D.IMP: 2
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	CATAPRESAN*30CPR 150MCG
D.2.1.1.2	Name of the Marketing Authorisation holder	BOEHRINGER INGELHEIM IT.SpA
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	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	Clonidine
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.3	Concentration number	150
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	Yes
D.3.11.13.1	Other medicinal product type	farmaco di natura chimica
D.IMP: 3
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	catapres-TTS
D.2.1.1.2	Name of the Marketing Authorisation holder	ALZA COORPORATION
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	Transdermal patch
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Transdermal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Clonidine
D.3.9.1	CAS number	4205-90-7
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	2
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	Yes
D.3.11.13.1	Other medicinal product type	farmaco di natura chimica

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	Transdermal patch
D.8.4	Route of administration of the placebo	Transdermal use
D.8 Placebo: 3
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

patients affected by coronary disease undergoing non cardiac surgery

pazienti affetti o a rischio di coronaropatia sottoposti ad intervento di chirurgia non cardiaca

E.1.1.1

Medical condition in easily understood language

patients affected by coronary disease

pazienti affetti o a rischio di coronaropatia

E.1.1.2

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	HLGT
E.1.2	Classification code	10011082
E.1.2	Term	Coronary artery disorders
E.1.2	System Organ Class	10007541 - Cardiac 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 determine the impact of clonidine versus placebo and ASA versus placebo on the 30-day risk of all-cause mortality or nonfatal MI in patients with, or at risk of, atherosclerosic disease who are undergoing noncardiac surgery.

valutare l` efficacia perioperatoria di farmaci noti, poco costosi e utilizzati a basso dosaggio (acido acetilsalicilico ASA- e clonidina) sulla mortalita` e sull incidenza di infarto miocardico non fatale a 30 giorni in pazienti affetti o a rischio di coronaropatia sottoposti a intervento di chirurgia non cardiaca

E.2.2

Secondary objectives of the trial

To determine the impact of perioperative administration of low-dose clonidine and separately low-dose ASA on each of the following individual secondary outcomes at 30 days after randomization: all-cause mortality, vascular mortality, MI, nonfatal cardiac arrest, cardiac revascularization procedure, pulmonary emboli, deep venous thrombosis, clinically important atrial fibrillation, rehospitalization for vascular reasons, length of hospital stay, length of intensive care unit / cardiac care unit (ICU/CCU) stay, and new acute renal failure requiring dialysis. 2. To determine the impact of perioperative administration of low-dose clonidine and separately low-dose ASA on the composite of all-cause mortality, nonfatal MI, and nonfatal stroke at 30 days after randomization. 3. To determine in each ASA stratum the impact on a composite outcome of all-cause mortality, nonfatal MI, cardiac revascularization procedure, nonfatal pulmonary emboli, and nonfatal deep venous thrombosis

1.det. l`impatto della sommin perioperatoria della clonidina a basso dosaggio e separatamente ASA a basso dosaggio per ciascuno dei seguenti risultati individuali sec.o a 30 gg dopo la randomizzazione:mortalità per qualsiasi causa,mortalità vascolare,infarto miocardico,arresto cardiaco non fatale,procedure di rivascolarizzazione cardiaca,embolia polmonare,trombosi venosa profonda,clinicamente importanti fibrillazione atriale,riospedalizzazione per motivi vascolare,durata della degenza ospedaliera,durata della terapia intensiva/unità di assistenza cardiaca(ICU/CCU),soggiorno,e nuova insufficienza renale acuta che richieda la dialisi.2.det. l`impatto della sommin perioperatoria della clonidina a basso dosaggio e separatamente ASA a basso dosaggio su un risultato composto di mortalità generale,infarto miocardico non fatale e ictus non fatale a 30 gg dopo la randomizzazione.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients are eligible if: 1. are aged >= 45 years old 2. are expected to require at least an overnight hospital admission after surgery; AND 3. fulfill one or more of the following 5 criteria history of : A. coronary artery disease; B. peripheral vascular disease; C. stroke; D. undergoing major vascular surgery; OR E. any 3 of the following 9 criteria: undergoing major surgery (i.e. intraperitoneal, intrathoracic, retroperitoneal, or major orthopedic surgery), history of congestive heart failure, transient ischemic attack, diabetes and currently taking an oral hypoglycemic agent or insulin, age > 70 years, hypertension, serum creatinine > 175 μmol/L (>2.0 mg/dl), history of smoking, within 2 years of surgery, undergoing urgent/emergent surgery.

pazienti di eta` superiore ai 45 anni; pazienti che richiedano almeno una notte di ricovero post intervento chirurgico e che soddisfino uno o piu` dei seguenti 6 requisiti: storia di patologia coronarica arteriosa; storia di patologie vascolari periferiche; storia di infarto; effettuazione di interventi chirurgici vascolari importanti; precedente rivascolarizzazione coronarica arteriosa; oppure che soddisfino almeno 3 dei seguenti 9 requisiti: -chirurgia maggiore , storia di scompenso cardiaco congestizio,retroperitoneale, attacco ischemico transiente,diabete ed assunzione corrente di terapia ipoglicemizzante od insulina,eta` > o pari a 70 anni,ipertensione,creatinina serica > 175micromol/L, abitudine al fumo entro 2 anni dall`intervento,necessita` di chirurgia d`urgenza

E.4

Principal exclusion criteria

1. consumption of ASA within 72 hours prior to surgery; 2. hypersensitivity or known allergy to ASA or clonidine; 3. systolic blood pressure < 105 mm Hg; 4. heart rate < 55 beats per minute in a patient who does not have a permanent pacemaker; 5. second or third degree heart block without a permanent pacemaker; 6. active peptic ulcer disease or gastrointestinal bleeding within previous 6 weeks; 7. intracranial hemorrhage (including subdural hematoma and parenchymal hematoma as a complication of primary ischemic stroke) documented by neuro-imaging, in the 6 months prior to randomization. This does not include petechial hemorrhagic transformation of a primary ischemic stroke; 8. subarachnoid hemorrhage or epidural hematoma unless the event occurred more than 6 months prior to randomization and the offending aneurysm or arterial lesion has been repaired; 9. drug-eluting coronary stent in the year prior to randomization;96 10. bare-metal coronary stent in the 6 weeks prior to randomization;96 11. thienopyridine (e.g., clopidogrel, ticlopidine, prasugrel)or ticagrelor within 72 hours prior to surgery ; or intention to restart a thienopyridine or ticagrelor during the first 7 days post op; 12. planned use during the first 3 days after surgery therapeutic dose anticoagulation (e.g., warfarin with a target INR > 2.0, dabigatran > 250 mg/day, or rivaroxaban > 10 mg/day) or a therapeutic subcutaneous or intravenous antithrombotic agent (defined as full dose unfractionated heparin [i.e., > 15, 000 u/24hrs], low molecular weight heparin [i.e., > 6,000 u/24hrs or enoxaparin: > 60 mg/24hrs], or fondaparinux [i.e., > 2.5mg/24hrs]; 13. undergoing intracranial surgery, carotid endarterectomy, or retinal surgery; 14. not consenting to participate in POISE-2 prior to surgery; OR 15. previously enrolled in POISE-2 Trial

1.consumo di ASA entro 72 ore prima dell`intervento; 2. ipersensibilita` o allergia ad ASA o clonidina; 3. pressione sistolica <105 mmHg; 4. frequenza cardiaca <55 battiti al minuto in un paziente che non dispone di un pacemaker permanente; 5. secondo o terzo grado di blocco cardiaco senza un pacemaker permanente; 6. ulcera peptica attiva o sanguinamento gastrointestinale entro sei settimane precedenti; 7. emorragia intracranica (compresi ematoma subdurale ed ematoma parenchimale come complicanza di ictus ischemico primario), documentata da neuro-imaging, nei 6 mesi prima della randomizzazione. Questo non include petecchiali trasformazioni emorragiche di un ictus ischemico primario; 8. emorragia subaracnoidea o ematoma epidurale a meno che l`evento si sia verificato piu` di 6 mesi prima della randomizzazione e l`aneurisma o lesione arteriosa sia stato riparato; 9. stent a eluizione di farmaco coronarico durante l`anno prima della randomizzazione; 96 10. bare-metal stent coronarico nelle 6 settimane prima della randomizzazione; 96 11. 1-tienopiridine (ad esempio, il clopidogrel, ticlopidina, prasugrel)o ticagrelor entro 72 ore prima dell`operazione o intenzione di ripristinare la terapia con thionepyridina o tiragrelor durante i primi 7 gg post operazione; 12. previsto utilizzo - durante i primi 3 giorni dopo l`intervento - di terapia anticoagulante (ad esempio, warfarin con un target INR> 2,0, dabigatran> 250 mg / die, o rivaroxaban> 10 mg / die) o di un agente terapeutico per via sottocutanea o endovenosa antitrombotici (definito come eparina non frazionata a dosaggio pieno [ie,> 15, 000 u/24hrs], cioe` l`eparina a basso peso molecolare del peso [,> 6.000 u/24hrs o enoxaparina:> 60 mg/24hrs], o fondaparinux [cioe`, 2.5mg/24hrs>] ; 13. pazienti sottoposti a chirurgia intracranica, endoarteriectomia carotidea, o a chirurgia retinica; 14. pazienti che non acconsentono di partecipare a POISE-2 prima della chirurgia 15. pazienti precedentemente arruolati in POISE-2 Trial

E.5 End points

E.5.1

Primary end point(s)

valutare l efficacia perioperatoria di farmaci noti, poco costosi e utilizzati a basso dosaggio (acido acetilsalicilico ASA- e clonidina) sulla mortalita' e sull incidenza di infarto miocardico non fatale a 30 giorni in pazienti affetti o a rischio di coronaropatia sottoposti a intervento di chirurgia non cardiaca

E.5.1.1

Timepoint(s) of evaluation of this end point

30 days from randomization

30 giorni dalla randomizzazione

E.5.2

Secondary end point(s)

the composite of all-cause mortality, nonfatal MI, and nonfatal stroke at 30 days after randomization

l`insieme delle cause di mortalita`, Mi non fatale, ed infarto non fatale a 30 gg dopo la randomizzazione

E.5.2.1

Timepoint(s) of evaluation of this end point

30 days after randomization

30 giorni dopo la randomizzazione

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

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)

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)

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

101

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

Canada

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

LVLS

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.1.3

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

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

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

Yes

F.3.3.7.1

Details of other specific vulnerable populations

pzianti che si sottopongono a chirurgia non cardiaca ceh soddisfino i criteri di inclusione

F.4 Planned number of subjects to be included

F.4.1

In the member state

1000

F.4.2

For a multinational trial

F.4.2.1

In the EEA

2000

F.4.2.2

In the whole clinical trial

10000

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

2010-10-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-02-04

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2015-03-17

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