Clinical Trials Register

Summary
EudraCT Number:	2016-005140-41
Sponsor's Protocol Code Number:	Saxa-Dapa1
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-06-17
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

2016-005140-41

A.3

Full title of the trial

A PHASE II, RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED, PARALLEL-GROUP, SINGLE CENTER PILOT STUDY OF THE ACUTE AND CHRONIC EFFECTS OF DAPAGLIFLOZIN PLUS SAXAGLIPTIN IN ADDITION TO METFORMIN VERSUS SINGLE ADDITION OF SAXAGLIPTIN OR DAPAGLIFLOZIN ON GLUCOSE METABOLISM IN PATIENTS WITH TYPE 2 DIABETES POORLY CONTROLLED WITH METFORMIN

Studio clinico pilota su singolo centro di fase II randomizzato in doppio cieco con controllo attivo a gruppi paralleli sugli effetti acuti e cronici dell¿associazione di saxagliptin con dapagliflozin in aggiunta a metformina rispetto all¿aggiunta del singolo componente sul metabolismo glucidico in pazienti con diabete tipo 2 in scarso controllo in trattamento con metformina

A.3.1

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

A study of the acute and chronic effects of dapagliflozin plus saxagliptin addition versus single addition of saxagliptin or dapagliflozin on glucose metabolism in patients with type 2 diabetes poorly controlled with metformin

Uno studio sugli effetti acuti e cronici dell¿associazione di saxagliptin con dapagliflozin in rispetto all¿aggiunta del singolo componente sul metabolismo glucidico in pazienti con diabete tipo 2 in scarso controllo in trattamento con metformina

A.3.2

Name or abbreviated title of the trial where available

Saxa-Dapa1

A.4.1

Sponsor's protocol code number

Saxa-Dapa1

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	AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA
B.1.3.4	Country	Italy
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	ASTRAZENECA SPA
B.4.2	Country	Italy
B.4.1	Name of organisation providing support	Dip. Univ. Medicina clinica e sperimentale Pisa
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	UO MALATTIE METABOLICHE E DIABETOLOGIA
B.5.2	Functional name of contact point	UO MALATTIE METABOLICHE E DIABETOLO
B.5.3	Address:
B.5.3.1	Street Address	VIA PARADISA 2
B.5.3.2	Town/ city	PISA
B.5.3.3	Post code	56124
B.5.3.4	Country	Italy
B.5.4	Telephone number	050995103
B.5.5	Fax number	050541521
B.5.6	E-mail	stefano.delprato@med.unipi.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	FORXIGA - 10 MG - COMPRESSE RIVESTITE CON FILM- USO ORALE - BLISTER CALENDARIZZATO (ALU/ALU) - 28 COMPRESSE
D.2.1.1.2	Name of the Marketing Authorisation holder	BRISTOL- MYERS SQUIBB/ASTRAZENECA EEIG
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.3.1	Product name	FORXIGA
D.3.2	Product code	FORXIGA
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	DAPAGLIFLOZIN
D.3.9.1	CAS number	461432-26-8
D.3.9.2	Current sponsor code	DAPAGLIFLOZIN
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	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	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	ONGLYZA - 5 MG-COMPRESSE RIVESTITE CON FILM -USO ORALE-BLISTER NON PERFORATO CALENDARIZZATO (ALU/ALU) 28 COMPRESSE
D.2.1.1.2	Name of the Marketing Authorisation holder	BRISTOL- MYERS SQUIBB/ASTRAZENECA EEIG
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.3.1	Product name	ONGLYZA
D.3.2	Product code	ONGLYZA
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	SAXAGLIPTIN CLORIDRATO
D.3.9.1	CAS number	361442-04-8
D.3.9.2	Current sponsor code	SAXAGLIPTIN CLORIDRATO
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	5
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	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
D.8 Placebo: 2
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

Patients with type 2 diabetes poorly controlled with metformin

Pazienti con diabete tipo 2 in scarso controllo in trattamento con metformina

E.1.1.1

Medical condition in easily understood language

Patients with type 2 diabetes

Pazienti con diabete tipo 2

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	21.1
E.1.2	Level	PT
E.1.2	Classification code	10067585
E.1.2	Term	Type 2 diabetes mellitus
E.1.2	System Organ Class	10027433 - Metabolism and nutrition disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	23.0
E.1.2	Level	PT
E.1.2	Classification code	10012607
E.1.2	Term	Diabetes mellitus inadequate control
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 determine the effect of the combination of dapagliflozin (a SGLT2-inhibitor) and saxagliptin (a DPP-4 inhibitor) on pancreatic hormones secretion and endogenous glucose production in Type 2 diabetic subjects through comparison of the effects of co-administration of Saxagliptin and Dapagliflozin vs. Saxagliptin or Dapagliflozin alone

Valutare l¿effetto della combinazione dapagliflozin (un inibitore SGLT2)/saxagliptin (un inibitore di DPP-4) sulla secrezione ormonale pancreatica e sulla produzione endogena di glucosio in soggetti affetti da diabete mellito tipo 2 rispetto all¿effetto esercitato dalla somministrazione delle singole componenti

E.2.2

Secondary objectives of the trial

To determine whether the effect of the combination of dapagliflozin (a SGLT2-inhibitor) and saxagliptin (a DPP-4 inhibitor) on glucose, insulin, c-peptide, FFA, GIP, GLP-1, hepatic glucose production and beta-cell function is different as compared to single agent administration

Valutare l¿ipotesi che la somministrazione combinata di saxagliptin e dapagliflozin moduli le concentrazioni plasmatiche di glucosio, insulina, c-peptide, FFA, GIP, GLP-1, la produzione epatica di glucosio e la funzione cellulare in maniera differente rispetto alla somministrazione delle singole componenti

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Males and females
2. Age = 35-70 years
3. BMI = 40 Kg/m2 and stable weight (± 3 lbs) over the preceding three months
4. Type 2 diabetes (HbA1c > 7 % and < 10 %)
5. Metformin on stable dose (at least 1500 mg/day) for at least 12 weeks before screening and at study initiation
6. Subjects who are women of childbearing potential must agree to utilize a highly effective contraceptive measure throughout the course of the study for the entire duration of the trial and the subsequent 30-day follow-upi n accordance with the CTFG recommendations
7. Subjects are capable of giving informed consent

1. Uomo o donna
2. Età = 35-70 anni
3. Indice di massa corporea (BMI) < 40 Kg/m2 e peso corporeo stabile (± 3 kg) nei precedenti 3 mesi
4. diabete mellito tipo 2 scarsamente controllato (HbA1c > 7.0% e <10.0% at screening)
5. terapia con metformina (almeno 1,500 mg/die) per almeno 12 settimane precedenti lo screening e prima dell’avvio dello studio
6. Donne in età fertile purchè accettino di utilizzare sistemi contraccetivi efficaci per l’intera durata dello studio e per i 30 giorni successivi al termine dello studio, in linea con le raccomandazioni del Clinical Trial Facilitation Group (CTFG ).
7. Soggetti in grado di dare il consenso informato

E.4

Principal exclusion criteria

1. Drugs known to affect glucose metabolism (other than metformin) for more than 14 days during the 12 weeks before screening
2. Known Dapagliflozin and Saxagliptin Excipient Hypersensitivity
3. Type 1 Diabetes or History of Ketoacidosis
4. history of cancer of any type;
5. cerebrovascular or symptomatic peripheral vascular disease;
6. heart disease class III or IV NYHA;
7. Estimated glomerular filtration rate (eGFR) =60 mL/min/1.73m2 or serum creatinine > 1.5mg/dL in men or >1.4mg/dL in women
8. Liver function enzymes higher more than two times the upper limit
9. Ongoing urinary tract infection
10. drug or alcohol abuse;
11. life expectancy <3 yrs
12. blood pressure >160/100 mmHg
13. Donation of blood to a blood bank, blood transfusion, or participation in a clinical study requiring withdrawal of > 400 mL of blood during the 8 weeks prior to the enrollment visit and at least 8 weeks thereafter
14. Women of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study
15. Women who are pregnant or breastfeeding
16. Patient with a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance which, in the opinion of the investigator or coordinator, might pose an unacceptable risk to the patient or interfere with trial procedures

1. Trattamento con ipoglicemizzanti orali diversi dalla metformina per più di 14 giorni nelle 12 settimane precedenti lo screening.
2. Ipersensibilità nota a saxagliptin e dapagliflozin e agli eccipienti
3. Diabete mellito tipo 1 o storia di chetoacidosi
4. Storia di neoplasia (qualsiasi tipo)
5. Patologia cerebrovascolare o malattia aterosclerotica sintomatica periferica
6. insufficienza cardiaca (NYHA III e IV)
7. Velocità di filtrazione glomerulare renale (eGFR), =60 mL/min/1.73m2 o valori di creatinina > 1.5mg/dL nell’uomo e >1.4mg/dL nella donna
8. Concentrazioni elevate degli enzimi epatici (> 2 volte il limite superiore della norma)
9. Concomitanti infezioni del tratto urinario
10. Abuso di alcool o droghe o sostanze tossiche
11. Aspettativa di vita < 3 anni
12. Ipertensione arteriosa non controllata (pressione arteriosa sistolica > 160 mmHg e diastolica >100 mmHg) al momento della randomizzazione
13. Donazione o trasfusioni di emoderivati o partecipazione a studi clinici che richiedano il prelievo di una quantità di sangue > 400 mL durante le 8 settimane precedenti la visita di arruolamento oppure intenzione di essere donatore entro 8 settimane dalla conclusione dello studio
14. Donne eta’ fertile impossibilitate o non consenzienti all’utilizzo di un valido sistema contraccetivo
15. Donne in gravidanza o in fase di allattamento
16. Paziente con storia, evidenza clinica, terapia, anomalia di laboratorio o ogni altra circostanza che a giudizio dell’investigatore pone il paziente a un rischio inaccettabile a causa delle procedure previste dallo studio

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is the difference in basal and post-meal endogenous glucose production (EGP) after 3 days (acute study) and after 4 week (chronic study) treatment with co-administration of Saxagliptin and Dapagliflozin vs. Saxagliptin or Dapagliflozin alone.

L’endpoint primario e’ stimare la differenza della produzione endogena di glucosio (EGP), basale e dopo pasto, dopo 3 giorni (studio acuto) e dopo 4 settimane (studio cronico) di trattamento con la combinazione Saxagliptin e Dapagliflozin rispetto alla singola somministazione di Saxagliptin o Dapagliflozin.

E.5.1.1

Timepoint(s) of evaluation of this end point

This timepoint will be achieved in a three years study

Questo timepoint sarà raggiunto durante lo studio di tre anni

E.5.2

Secondary end point(s)

The secondary end-points are the differences in:
¿ total glucose rate of disappearance,
¿ total and exogenous glucose rate of appearance,
¿ plasma insulin, C-peptide, glucagon, GLP-1, GIP, FFA,
¿ beta-cell function from the test meal based on a model that describes the relationship between insulin secretion and glucose concentration as the sum of two components (16-17),
¿ Peripheral insulin sensitivity assessed by Matsuda¿s Composite Insulin Sensitivity Index (18), Oral Glucose Insulin Sensitivity (OGIS)(19), and Stumvoll¿s Insulin Sensitivity Index (20),
after 3 days (acute study) and after 4 week (chronic study) treatment with co-administration of Saxagliptin and Dapagliflozin vs. Saxagliptin or Dapagliflozin alone.

L¿endpoint secondario e¿ valutare la differenza in: velocit¿ di comparsa e scomparsa del glucosio, concentrazioni di insulina, C peptide, glucagone, GLP-1, GIP e FFA, funzione beta cellulare dopo test del pasto misto basato su un modello che descrive la relazione tra secrezione insulinica e concentrazione di glucosio come somma delle due componenti (8,9) e sensibilit¿ periferica all¿insulina misurata mediante il Matsuda¿s Composite Insulin Sensitivity Index, Oral Glucose Insulin Sensitivity (OGIS) e lo Stumvoll¿s Insulin Sensitivity Index (10,11,12), dopo 3 giorni (studio acuto) e dopo 4 settimane (studio cronico) di trattamento con la combinazione Saxagliptin e Dapagliflozin rispetto alla singola somministazione di Saxagliptin o Dapagliflozin

E.5.2.1

Timepoint(s) of evaluation of this end point

This timepoint will be achieved in a three years study

Questo timepoint sar¿ raggiunto durante lo studio di tre anni

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

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

Yes

E.6.13.1

Other scope of the trial description

ACUTE AND CHRONIC EFFECTS OF DAPAGLIFLOZIN PLUS SAXAGLIPTIN ADDITION VERSUS SINGLE ADDITION OF ON GLUCOSE METABOLISM

effetti acuti e cronici dell¿associazione di saxagliptin con dapagliflozin rispetto all¿aggiunta del singolo componente sul metabolismo glucidico

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

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Associazione di saxagliptin con dapagliflozin rispetto all¿aggiunta del singolo componente

DAPAGLIFLOZIN PLUS SAXAGLIPTIN ADDITION VERSUS SINGLE ADDITION OF SAXAGLIPTIN OR DAPAGLIFLOZIN

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

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.1.1.1

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:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

F.4.2.2

In the whole clinical trial

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)

The plans for treatment or care after the subject has ended his/her participation will be not affected by this study and they will continue the standard care.

I programmi per il trattamento o l'assistenza per i soggetti al termine della loro partecipazione allo studio non saranno influenzati dallo studio ed essi continueranno lo standard previsto dal centro

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

2017-05-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-04-13

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

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