Clinical Trials Register

Summary
EudraCT Number:	2013-005571-40
Sponsor's Protocol Code Number:	9207
National Competent Authority:	Netherlands - Competent Authority
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2014-01-14
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

Netherlands - Competent Authority

A.2

EudraCT number

2013-005571-40

A.3

Full title of the trial

Randomized Evaluation of short-term DUal anti platelet therapy in patients with acute coronary syndrome treated with the COMBO dual-therapy stEnt

Gerandomiseerde Evaluatie van kortdurende DUbbele anti-bloedplaatjes therapie in patiënten met een acuut coronair syndroom behandeld met de COMBO dubbele therapie stEnt

A.3.1

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

Randomized Evaluation of short-term DUal anti platelet therapy in patients with acute coronary syndrome treated with the COMBO dual-therapy stEnt

Gerandomiseerde Evaluatie van kortdurende DUbbele anti-bloedplaatjes therapie in patiënten met een acuut coronair syndroom behandeld met de COMBO dubbele therapie stEnt

A.3.2

Name or abbreviated title of the trial where available

REDUCE

A.4.1

Sponsor's protocol code number

9207

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	Diagram B.V.
B.1.3.4	Country	Netherlands
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	OrbusNeich
B.4.2	Country	Netherlands
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Diagram B.V.
B.5.2	Functional name of contact point	J. Klijn
B.5.3	Address:
B.5.3.1	Street Address	Dokter Stolteweg 96
B.5.3.2	Town/ city	Zwolle
B.5.3.3	Post code	8025AZ
B.5.3.4	Country	Netherlands
B.5.4	Telephone number	00310384242999
B.5.5	Fax number	00310384242990
B.5.6	E-mail	reduce.study@diagram-zwolle.nl

D. IMP Identification
D.IMP: 1
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	Aspirin
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
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	Aspirin
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.3.11 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.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	Plavix
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
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.3.11 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.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	Yes
D.2.1.1.1	Trade name	Prasugrel
D.2.1.1.2	Name of the Marketing Authorisation holder	Eli Lilly
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
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.3.11 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.IMP: 4
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	Ticagrelor
D.2.1.1.2	Name of the Marketing Authorisation holder	AstraZeneca
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
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.3.11 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	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

Acute coronary syndrome

Acuut coronair syndroom

E.1.1.1

Medical condition in easily understood language

Occlusion/obstruction blood vessel of the heart

verstopping/vernauwing van een bloedvat van het hart

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	18.1
E.1.2	Level	LLT
E.1.2	Classification code	10064348
E.1.2	Term	Non STEMI
E.1.2	System Organ Class	100000004849

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.1
E.1.2	Level	LLT
E.1.2	Classification code	10064346
E.1.2	Term	STEMI
E.1.2	System Organ Class	100000004849

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.1
E.1.2	Level	LLT
E.1.2	Classification code	10002385
E.1.2	Term	Angina pectoris unstable
E.1.2	System Organ Class	100000004849

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 safety of 90-days versus standard 360-days of DAPT

Evalueren van de veiligheid van 90 dagen versus de standaard 360 dagen DAPT

E.2.2

Secondary objectives of the trial

Not applicable

Niet van toepassing

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. The patient must be ≥18 years of age
2. The patient has been diagnosed with STEMI, NSTEMI or UA
3. The Patient is willing to comply with specified follow-up evaluations
4. The Patient has been informed of the nature of the study, agrees to its provisions and has been provided written informed consent, approved by the appropriate Medical Ethics Committee (MEC), Institutional Review Board (IRB), or Human Research Ethics Committee (HREC)
5. Successful COMBO stent implantation (TIMI 3 flow with residual stenosis < 20% based visual estimation), with no clinical adverse event during hospitalization (Death, stent thrombosis (ST), stroke, target vessel revascularisation (TVR), bleeding (BARC II, III, V))

1. De patiënt moet ≥18 jaar zijn
2. De patiënt is gediagnosticeerd met een STEMI, NSTEMI of IAP
3. De patiënt is bereid om mee te werken aan de follow ups van de studie
4. De patiënt is geinformeerd over de studie, gaat akkoord met de dekking en heeft schriftelijk informed consent gegeven voor het IC dat beoordeeld is door de medische ethische commissie (METC), het review board van het instituut (IRB) of the menselijke onderzoeks ethische commissie (HREC)
5. Successvolle COMBO stent implantatie (TIMI 3 flow met residuale stenosis < 20% gebasseerd op visuale schatting), met geen klinische adverse events tijdens opname (overlijden, beroerte, target vessel revascularisatie (TVR) of bloeding (BARC II, III, V))

E.4

Principal exclusion criteria

1. Patients presenting with cardiogenic shock
2. Patients with recent major bleeding complications or contraindication to DAPT, such as:
a) Hypersensitivity to Aspirin, Clopidogrel, Prasugrel or Ticagrelor
b) Need for oral anticoagulation
c) History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia) or refusal of blood transfusions
d) History of intracerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke
e) Stroke or transient ischemic attack within the past 6 months or any permanent residual neurologic defect
f) Gastrointestinal or genitourinary bleeding within the last 2 months or major surgery within 6 weeks
g) Recent history (<3 months prior to randomization) or known current platelet count <100 000 cells/mm3 or hemoglobin <10 g/dL
h) An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 12 months post enrollment
3. Planned need for concomitant cardiac surgery (e.g., valve surgery or resection of aortic or left ventricular aneurysm etc.)
4. Planned intervention of another lesion (target vessel or non-target vessel) after index hospital discharge
5. Any revascularization performed within index hospitalization with other stents than COMBO
6. Potential for non-compliance towards the requirements in the trial protocol (especially the medical treatment) or follow-up visits
7. Patients requiring permanent DAPT due to comorbidities
8. Patient has received any organ transplant or is on a waiting list for any organ transplant
9. Life expectancy of less than 2 years
10. Pregnancy or intention to become pregnant during the course of the trial
11. Any significant medical or mental condition, which in the Investigator’s opinion may interfere with the patient’s optimal participation in the study
12. Currently participating in another investigational drug or device study
13. Patients who have been treated with another DES within 9 months prior to the index procedure

1. Patiënten die zich presenteren met een cardiogene shock
2. Patiënten met een recente majeure bloedingscomplicaties of contraindicatie voor DAPT:
a) Overgevoeligheid voor Aspirine, Clopidogrel, Prasugrel of Ticagrelor
b) Indicatie hebben voor orale anticoagulantia
c) Voorgeschiedenis van gevoeligheid voor bloedingen of antistollingsstoornis (inclusief heparine geinduceerde trombocytopenie) of het niet accepteren van bloedtransfusies
d) Voorgeschiedenis van toename intracerebrale massa, aneurysma, arterioveneuze malformatie of hersenbloeding
e) Beroerte of TIA binnen 6 maanden of een permanente residuele neurologische afwijking
f) Gastrointestinale of urogenitale bloeding binnen de afgelopen 2 maanden of een grote operatie binnen 6 weken
g) Recente voorgeschiedenis (3 maanden voor randomizatie) van bloedplaatjes aantal van <100 000 cells/mm3 of hemoglobine <10 g/dL
h) Een electieve chirurgische procedure die gepland is en interruptie van de thienopyridine therapie tot gevolg heeft 12 maanden na inclusie
3. Geplande cardiaal gerelateerde operatie (klepoperatie of resectie van de aorta of linker ventriculair aneurysma etc).
4. Geplande interventie van een andere laesie (target vessel of non-target vessel) na ontslag uit het ziekenhuis behorende bij de index ziekenhuisopname
5. Iedere revascularisatie die is uitgevoerd binnen de index ziekenhuisopname met een andere stent dan de COMBO stent
6. Mogelijkheid van non-compliance betreffende de eisen van het protocol van de studie (met name de behandeling met medicijnen) of tijdens follow-up visites
7. Patiënten die permanent DAPT nodig hebben in verband met comorbiditeit
8. Patiënten die een orgaantransplantatie hebben ondergaan is op de wachtlijst staat voor orgaantransplantatie
9. Levensverwachting van minder dan 2 jaar
10. Zwanger zijn of de intentie hebben om zwanger te worden tijdens de studie
11. Iedere significante medische- of mentale conditie, die volgens de onderzoeker kan interfereren met de patient zijn deelname aan de studie
12. Huidige deelname aan een andere medicatie- of device studie
13. Patienten die behandeld zijn met een andere DES binnen 9 maanden vóór de index procedure

E.5 End points

E.5.1

Primary end point(s)

Composite of all cause mortality, myocardial infarction (MI), stent thrombosis (ST), stroke, target vessel revascularisation (TVR), bleeding (BARC II, III, V) at 360 days

Composite of all cause mortaliteit, myocard infarct (MI), stenttrombose (ST), target vessel revascularisatie (TVR), beroerte, bloeding (BARC II, III, V) op 360 dagen

E.5.1.1

Timepoint(s) of evaluation of this end point

360 days

360 dagen

E.5.2

Secondary end point(s)

- Bleeding (BARC II, III, V) at 360 days
- All cause mortality, MI, ST, stroke, TVR, bleeding (BARC II, III, V) at 720 days
- All cause mortality, MI, ST, stroke and TVR at 360 and 720 days
- Mortality at 360 and 720 days
- Cardiac Mortality at 360 and 720 days
- Any MI at 360 and 720 days
- ST at 360 and 720 days
- Repeat revascularization at 360 and 720 days
- Time to event as defined by the occurrence of one of the following: all cause mortality, MI, ST, stroke, TVR or bleeding (BARC II, III, V) within 360 and 720 days
- Prespecified landmark analysis of Primary Endpoint (without TVR) from 90 and 360 days

- Bloeding (BARC II, III, V) op 360 dagen
- All cause mortaliteit, MI, ST, TVR, beroerte, bloeding (BARC II, III, V) op 720 dagen
- All cause mortaliteit, MI, ST, TVR en beroerte op 360 en 720 dagen
- Mortaliteit op 360 en 720 dagen
- Cardiale mortaliteit op 360 en 720 dagen
- Alle MI's op 360 en 720 dagen
- ST op 360 en 720 dagen
- Nieuwe revascularisatie op 360 en 720 dagen
- Tijd tot event analyse, gedefinieerd als dat één van de volgende events plaatsvindt: all cause mortaliteit, MI, ST, beroerte, TVR of bloeding (BARC II, III, V) binnen 360 en 720 dagen
- Vooraf gespecificeerde landmark analyse van het primaire eindpunt (zonder TVR) van 90 en 360 dagen

E.5.2.1

Timepoint(s) of evaluation of this end point

- 360 days
- 720 days

- 360 dagen
- 720 dagen

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

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

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

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Duur van toediening medicatie is langer

Duration of administration of drugs is longer

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

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

Belgium

Germany

Hong Kong

Hungary

Indonesia

Italy

Malaysia

Netherlands

Poland

Singapore

Thailand

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 last visit of the last patient

De laatste follow-up visite van de laatste patient

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.1.1.1

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:

750

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

750

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

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

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

1500

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)

None

Geen

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

2014-01-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-04-17

P. End of Trial
P.	End of Trial Status	Ongoing

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Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
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