Clinical Trials Register

Summary
EudraCT Number:	2018-004059-18
Sponsor's Protocol Code Number:	17909
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2019-04-12
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

Spain - AEMPS

A.2

EudraCT number

2018-004059-18

A.3

Full title of the trial

A Multicenter, Randomized, Parallel Group, Double Blind, Active and Placebo Controlled Study of BAY 1753011, a Dual V1a/V2 Vasopressin Receptor Antagonist, in Patients with Congestive Heart Failure: AVANTI Study

Ensayo multicéntrico, aleatorizado, doble ciego, de grupos paralelos y comparativo con un control activo y placebo de BAY 1753011, un antagonista dual de los receptores V1a/V2 de la vasopresina, en pacientes con insuficiencia cardíaca congestiva. Ensayo AVANTI

A.3.1

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

A phase II trial to study BAY 1753011 in patients with Congestive Heart Failure

Ensayo fase II para estudiar BAY 1753011 en pacientes con insuficiencia cardíaca congestiva

A.3.2

Name or abbreviated title of the trial where available

AVANTI Study

Ensayo AVANTI

A.4.1

Sponsor's protocol code number

17909

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	Bayer AG
B.1.3.4	Country	Netherlands
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	Bayer AG
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Bayer AG
B.5.2	Functional name of contact point	Bayer Clinical Trials Contact
B.5.3	Address:
B.5.3.1	Street Address	Müllerstrasse 178
B.5.3.2	Town/ city	Berlin
B.5.3.3	Post code	13342
B.5.3.4	Country	Germany
B.5.4	Telephone number	0034.900102372
B.5.6	E-mail	clinical-trials-contact@bayer.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	BAY 1753011 30mg
D.3.2	Product code	BAY 1753011
D.3.4	Pharmaceutical form	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	N/A
D.3.9.1	CAS number	N/A
D.3.9.2	Current sponsor code	BAY 1753011
D.3.9.3	Other descriptive name	BAY 1753011
D.3.9.4	EV Substance Code	SUB177066
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	30
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	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	BAY 1753011 5mg
D.3.2	Product code	BAY 1753011
D.3.4	Pharmaceutical form	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	N/A
D.3.9.1	CAS number	N/A
D.3.9.2	Current sponsor code	BAY 1753011
D.3.9.3	Other descriptive name	BAY 1753011
D.3.9.4	EV Substance Code	SUB177066
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	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	Furorese® 40 mg Tabletten
D.2.1.1.2	Name of the Marketing Authorisation holder	Hexal AG
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	Furorese® 40 mg Tabletten
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	FUROSEMIDE
D.3.9.1	CAS number	54-31-9
D.3.9.2	Current sponsor code	N/A
D.3.9.3	Other descriptive name	FUROSEMIDE
D.3.9.4	EV Substance Code	SUB07849MIG
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	40
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	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	Coated tablet
D.8.4	Route of administration of the placebo	Oral 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

Heart failure

Insuficiencia cardiaca

E.1.1.1

Medical condition in easily understood language

Heart failure

Insuficiencia cardiaca

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	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10008908
E.1.2	Term	Chronic heart failure
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 assess the efficacy of 30 mg of BAY 1753011, with or without furosemide, versus furosemide alone in patients with HF and objective evidence of congestion

Evaluar la eficacia de 30 mg de BAY 1753011, con o sin furosemida, frente a la furosemida en monoterapia en pacientes con IC e indicios objetivos de congestión

E.2.2

Secondary objectives of the trial

To assess the safety and pharmacodynamics of 30 mg of BAY 1753011, with or without furosemide, versus furosemide alone in patients with HF and objective evidence of congestion

Evaluar la seguridad y la farmacodinámica de 30 mg de BAY 1753011, con o sin furosemida, frente a la furosemida en monoterapia en pacientes con IC e indicios objetivos de congestión.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Written informed consent signed before any study-specific procedure.
2. Men and women aged >= 18 years <= 85 years. Lower age limit may be higher if legally requested in the participating country.
3. Men must agree to use condoms during sexual intercourse.
4. Women can only be enrolled if of non-child bearing potential
5. History of CHF (HF with reduced, preserved or mid-range EF) on individually optimized treatment with HF medications unless contraindicated or not tolerated, for at least 12 weeks prior to index hospitalization and in accordance with guidelines.
6. Patients admitted to the hospital with a primary diagnosis of decompensated HF including symptoms and signs of fluid overload requiring IV diuretic therapy in the ER or any time between day 1-3 of hospital admission
AND
7. At least one of the following 5 parameters any day between 3-7 of index hospitalization
Ai. Drop in BNP or NT-proBNP <= 30% from admission values (if measured during index hospitalization) or
Aii. BNP >= 500 pg/ml or NT-proBNP >= 1800 pg/ml at screening
B. BW loss <0.4 kg per 40 mg furosemide at day 4 of index hospitalization
C. CCS >= 2
D. Hypervolemic hyponatremia defined as serum sodium < 136 mmol/l
E. In hospital worsening renal function defined as increased serum creatinine >= 0.3 mg/dl compared to index hospitalization admission values
AND at least one the following
Ei. JVP >= 10 cm on physical examination
Eii. IVC diameter > 21 mm
Eiii. IVC collapse with sniff < 50%
Eiv. At least 2+ peripheral edema or pulmonary edema or pleural effusion on chest X-ray or clinical exam

1. Consentimiento informado por escrito firmado antes de que se realice cualquier procedimiento específico del ensayo.
2. Hombres y mujeres ≥18 años y ≤85 años. La edad mínima puede ser mayor si así lo estipula la ley en el país participante.
3. Los hombres deben estar de acuerdo en usar preservativo durante las relaciones sexuales.
4. Las mujeres solo pueden ser incluidas si ya no tienen posibilidad de quedar embarazadas.
5. Antecedentes de ICC (IC con FE reducida, preservada o de rango medio) en tratamiento individualmente optimizado con medicamentos para la IC a menos que esté contraindicado o no se tolere, durante al menos 12 semanas antes de la hospitalización inicial y de acuerdo con las guías.
6. Pacientes ingresados en el hospital con un diagnóstico primario de IC descompensada con signos y síntomas de hipervolemia, que precisan tratamiento diurético intravenoso en el servicio de urgencias o en cualquier momento entre el día 1 y 3 del ingreso hospitalario (hospitalización inicial)
Y
7. Al menos uno de los cinco parámetros siguientes cualquier día entre el día 3 y el día 7 de la hospitalización inicial (período de selección):
Ai. Disminución de BNP o NT-proBNP ≤30 % con respecto a los valores del ingreso (si se miden durante la hospitalización inicial) o
Aii. BNP ≥500 pg/ml o NT-proBNP ≥1800 pg/ml en la selección (días 3 a 7 de la hospitalización inicial)
B.Pérdida de peso corporal (PC) <0,4 kg por 40 mg de furosemida el día 4 de la hospitalización inicial.
C. Puntuación de congestión compuesta (CCS, Composite congestion score) ≥2.
D. Hiponatremia hipervolémica definida como sodio sérico <136 mmol/l.
E. En el hospital, empeoramiento de la función renal, definida como un aumento de la creatinina sérica ≥0,3 mg/dl en comparación con los valores de ingreso en la hospitalización inicial
Y, al menos, uno de los siguientes:
Ei. Presión venosa yugular (PVY) ≥10 cm en la exploración física.
Eii. Diámetro de la vena cava inferior (VCI) >21 mm.
Eiii. Colapso de la VCI con inhalación brusca <50 %.
Eiv. Al menos, edema periférico o edema pulmonar o derrame pleural 2+ en radiografía de tórax o exploración clínica.

E.4

Principal exclusion criteria

1. BW > 150 kg at screening
2. Known hypersensitivity to the study drugs
3. Participation in another interventional clinical study or treatment with investigational medicinal product 30 days or five half-lives of the investigational drug prior to screening
4. Any other condition or therapy that would make the subject unsuitable for this study and would not allow participation for the full planned study period in the judgment of the investigator
5. Malignancy or other non-cardiac condition limiting life expectancy to < 1 year, per physician judgment
6. Known current alcohol and/or illicit drug abuse that may interfere with the subject’s safety and / or compliance at the discretion of the investigator
7. Close affiliation with the investigational site; e.g., a close relative of the investigator, dependent person
8. Acute de-novo HF
9. Active or history of acute inflammatory heart disease, within 3 months prior to screening, e.g., acute myocarditis
10. Acute coronary syndrome, including unstable angina, NSTEMI or STEMI, or major CV surgery including CABG, PCI within 3 months prior to screening
11. Implantation of a CRT device within 3 months prior to screening
12. Stroke or carotid angioplasty within 3 months prior to screening
13. History of heart transplant or need for urgent heart transplantation, or presence of left ventricular assist device
14. Any primary cause of HF scheduled for surgery or interventional therapy (e.g., TAVI), e.g., valve disease such as severe aortic stenosis or mitral valve regurgitation
15. Hemodynamically significant ventricular arrhythmias or therapeutic defibrillator shock within 4 weeks prior to screening
16. Resting HR while awake of < 50 BPM or > 110 BPM (in case of AF > 120 BPM) at the time of screening or at randomization
17. Symptomatic hypotension with systolic BP < 95 mmHg during screening or at randomization
18. Any systolic (BP) < 85 mmHg during screening or at randomization
19. Complex congenital heart disease
20. Sepsis or ongoing systemic inflammation
21. Hypertrophic obstructive or restrictive cardiomyopathy
22. Requirement of mechanical support or ultrafiltration/hemodialysis
23. Use of IV vasodilators or IV inotropic support within 24 hours prior to randomization
24. Estimated GFR of < 30 ml/min/1.73 m2 determined by the MDRD equation at screening
25. Serum potassium >= 5.5 mmol/L or <= 3.3 mmol/L at screening
26. Serum sodium >= 146 mmol/L or <= 130 mmol/L at screening
27. Hepatic insufficiency classified as Child-Pugh B or C
28. Syndrome of Inappropriate Antidiuretic Hormone Secretion
29. Diabetes insipidus
30. Thyroid disease requiring current treatment and/or (sub)clinical hyperthyroidism or hypothyroidism
31. Concomitant treatment with potassium-sparing diuretic (with the exception of MRA) that cannot be stopped prior to randomization and for the duration of the treatment period
32. Concomitant treatment with strong and moderate inducers or inhibitors of CYP3A4
33. Concomitant treatment with probenecid

1. PC >150 kg en la selección
2. Hipersensibilidad conocida a los fármacos del ensayo (BAY 173011 y furosemida, o excipientes).
3. Participación en otro ensayo clínico de intervención o tratamiento con un medicamento en investigación durante 30 días o cinco semividas del medicamento en investigación antes de la selección.
4. Cualquier otra afección o tratamiento que haga que el sujeto no sea apto para este ensayo y que, a juicio del investigador, no permita la participación durante todo el período de ensayo planificado.
5. Neoplasia maligna u otra afección no cardíaca que limite la esperanza de vida a <1 año, según el criterio del médico.
6. Abuso actual conocido de alcohol y/o drogas ilícitas que puedan interferir con la seguridad y/o el cumplimiento del sujeto según el criterio del investigador.
7. Relación estrecha con el centro en que se realiza la investigación; p. ej., ser familiar próximo del investigador, o bien ser dependiente del centro (es decir, ser empleado o estudiante en el mismo).
8. IC aguda de nueva aparición.
9. Enfermedad cardíaca inflamatoria aguda activa o antecedentes de la misma en los 3 meses anteriores a la selección, por ejemplo, miocarditis aguda.
10. Síndrome coronario agudo, incluida angina inestable, IAMSEST o IAMEST, o cirugía CV mayor, incluida revascularización coronaria (RVC), intervención coronaria percutánea (ICP), en los 3 meses anteriores a la selección.
11. Implante de un dispositivo de tratamiento de resincronización cardíaca (TRC) en los 3 meses anteriores a la selección.
12. Accidente cerebrovascular o angioplastia carotídea en los 3 meses anteriores a la selección.
13. Antecedentes de trasplante de corazón o necesidad de un trasplante de corazón urgente, o presencia de un dispositivo de asistencia ventricular izquierda.
14. Cualquier causa primaria de insuficiencia cardíaca programada para cirugía o tratamiento intervencionista (por ejemplo, TAVI), por ejemplo, valvulopatía como estenosis aórtica grave o insuficiencia mitral.
15. Arritmias ventriculares hemodinámicamente significativas o choque con desfibrilador terapéutico en las 4 semanas anteriores a la selección.
16. Frecuencia cardíaca (FC) en reposo mientras está despierto <50 latidos por minuto (l.p.m.) o >110 l.p.m. (en caso de fibrilación auricular >120 l.p.m.) en el momento de la selección o la aleatorización.
17. Hipotensión sintomática con presión arterial sistólica <95 mmHg durante la selección o en la aleatorización
18. Cualquier (PA) sistólica <85 mmHg durante la selección o en la aleatorización.
19. Cardiopatía congénita compleja.
20. Sepsis o inflamación sistémica activa(SRIS).
21. Miocardiopatía hipertrófica obstructiva o restrictiva.
22. Necesidad de soporte mecánico (p. ej., balón de contrapulsación intraórtico, intubación endotraqueal, ventilación mecánica o cualquier dispositivo de asistencia ventricular) o ultrafiltración/hemodiálisis.
23. Uso de vasodilatadores intravenosos (p. ej., nitratos) o soporte inótropo intravenoso en las 24 horas previas a la aleatorización.
24. Tasa de filtración glomerular estimada <30 ml/min/1,73 m2 determinada por la ecuación de modificación de la dieta en enfermedad renal en la selección; reevaluaciones permitidas según sea clínicamente necesario.
25. Potasio sérico ≥5,5 mmol/l o ≤3,3 mmol/l en la selección; reevaluaciones permitidas según sea clínicamente necesario.
26. Sodio sérico ≥146 mmol/l o ≤130 mmol/l en la selección; reevaluaciones permitidas según sea clínicamente necesario.
27. Insuficiencia hepática clasificada como Child-Pugh B o C.
28. Síndrome de secreción inadecuada de hormona antidiurética (SIADH).
29. Diabetes insípida.
30. Enfermedad de la tiroides que requiere tratamiento actual y/o hipertiroidismo o hipotiroidismo (sub)clínico.
31. Tratamiento concomitante con diuréticos ahorradores de potasio (con la excepción del antagonista del receptor de mineralocorticoides [ARM]) que no se pueda interrumpir antes de la aleatorización y durante el período de tratamiento.
32. Tratamiento concomitante con inductores o inhibidores fuertes y moderados de CYP3A4 (se proporcionará al investigador una lista con medicamentos concomitantes prohibidos).
33. Tratamiento concomitante con probenecid.

E.5 End points

E.5.1

Primary end point(s)

PART A: Change in body weight and serum creatinine (Day 1 vs. Day 30)

PART B: Change in body weight and BUN/creatinine ratio (Day 30 vs. Day 60)

PARTE A: Cambio en el peso corporal y la creatinina sérica (Día 1 frente a Día 30).

PARTE B: Cambio en el peso corporal y la relación BUN/creatinina (Día 30 frente a Día 60).

E.5.1.1

Timepoint(s) of evaluation of this end point

Day 30 and day 60

Día 30 y Día 60

E.5.2

Secondary end point(s)

• Safety by TEAE reporting (including SAE)
• Pharmacodynamics by change in augmentation index

•Seguridad mediante notificación de AADT (incluidos AAG).
•Farmacodinámica mediante el cambio en el índice de sinergia.

E.5.2.1

Timepoint(s) of evaluation of this end point

Day 30 and day 60

Día 30 y Día 60

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

Yes

E.6.7

Pharmacodynamic

Yes

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

Biomarkers and Quality of Life

Biomarcadores y Calidad de Vida

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

Yes

E.8.2.3

Other

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

Austria

Bulgaria

Germany

Greece

Hungary

Israel

Italy

Poland

Portugal

Spain

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

última visita del último sujeto

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:

104

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

310

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

384

F.4.2.2

In the whole clinical trial

414

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)

After completion of the study the patient will be treated with approved/available standard of care therapy as outlined in the international guidelines

Una vez finalizado el ensayo, el paciente será tratado con un tratamiento estándar aprobado / disponible como se describe en las guías internacionales.

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

2019-07-02

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-06-24

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2021-05-21

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Orphan Designation Number:
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