Clinical Trials Register

Summary
EudraCT Number:	2015-002676-24
Sponsor's Protocol Code Number:	D1690C00023
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:	2015-10-05
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

2015-002676-24

A.3

Full title of the trial

An exploratory Phase II/III, randomized, double-blind, placebo controlled,
parallel design study to evaluate the efficacy, safety and
pharmacodynamics of dapagliflozin and dapagliflozin in combination with
saxagliptin in CKD3 patients with type 2 diabetes mellitus and albuminuria
treated with ACEi or ARB.

Ensayo clínico exploratorio de fase II/III, aleatorizado, doble ciego, controlado con placebo, de grupos paralelos para evaluar la eficacia, seguridad y farmacodinamia de dapagliflozina y de la combinación de dapagliflozina con saxagliptina en pacientes con enfermedad renal crónica en estadio 3 (ERC3), diabetes mellitus tipo 2 y albuminuria tratados con inhibidores de la enzima convertidora de la angiotensina (iECA) o bloqueantes de los receptores de la angiotensina II (BRA)- DELIGHT

A.3.1

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

A study to evaluate the efficacy and safety of dapagliflozin and dapagliflozin
in combination with saxagliptin in type 2 diabetes with kidney disease.

Ensayo para evaluar el efecto y la seguridad de dapaglifozina y dapaglifozina en combinación con saxagiptina en pacientes con diabetes tipo 2 con enfermedad renal crónica.

A.3.2

Name or abbreviated title of the trial where available

DELIGHT

A.4.1

Sponsor's protocol code number

D1690C00023

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	AstraZeneca AB
B.1.3.4	Country	Sweden
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	AstraZeneca AB
B.4.2	Country	Sweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	AstraZeneca Farmacéutica Spain, S.A.
B.5.2	Functional name of contact point	Unidad de Investigación Clínica
B.5.3	Address:
B.5.3.1	Street Address	C/Serrano Galvache, 56; Parque Norte
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28033
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34900200444
B.5.6	E-mail	informacionEECC-Spain@astrazeneca.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Forxiga
D.2.1.1.2	Name of the Marketing Authorisation holder	AstraZeneca AB
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Dapagliflozin
D.3.4	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 propanediol
D.3.9.1	CAS number	960404-48-2
D.3.9.3	Other descriptive name	DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE
D.3.9.4	EV Substance Code	SUB90205
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.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
D.2.1.1.2	Name of the Marketing Authorisation holder	AstraZeneca AB
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Saxagliptin
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
D.3.9.1	CAS number	361442-04-8
D.3.9.3	Other descriptive name	SAXAGLIPTIN
D.3.9.4	EV Substance Code	SUB25220
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	2.5
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.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

CKD3 patients with type 2 diabetes mellitus and albuminuria.

ERC 3A pacientes con diabetes mellitus tipo 2 y albuminuria.

E.1.1.1

Medical condition in easily understood language

Diabetes

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	18.0
E.1.2	Level	LLT
E.1.2	Classification code	10045250
E.1.2	Term	Type II diabetes mellitus with renal manifestations
E.1.2	System Organ Class	100000004857

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Primary objectives for the Saxagliptin/Dapagliflozin treatment arm
- To compare the mean change from baseline in HbA1c between dapagliflozin 10 mg plus saxagliptin 2.5 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes and CKD stage 3.- To compare the mean percent change from baseline in urine albumin-to creatinine ratio (UACR) between dapagliflozin 10 mg plus saxagliptin 2.5 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes and CKD stage 3. Primary objective for the Dapagliflozin treatment arm. - To compare the mean percent change from baseline in urine albumin-to creatinine ratio
(UACR) between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes and CKD stage 3.

Objetivos principales para el grupo de tratamiento con saxagliptina/dapagliflozina
- Comparar el cambio medio respecto al momento basal de la HbA1c entre 10 mg de dapagliflozina más 2,5 mg de saxagliptina y placebo, tras 24 semanas de admón. oral de tto. doble ciego en pacientes con diabetes tipo 2 y ERC en estadio 3.
- Comparar el cambio medio porcentual respecto al momento basal en el cociente albúmina/creatinina en orina (CACo) entre 10 mg de dapagliflozina más 2,5 mg de saxagliptina y placebo, tras 24 semanas de admón. oral de tto. doble ciego en pacientes con diabetes tipo 2 y ERC en estadio 3.
Objetivo ppal. para el grupo de tto. con dapagliflozina
- Comparar el cambio medio porcentual respecto al momento basal en el cociente albúmina/creatinina en orina (CACo) entre 10 mg de dapagliflozina y placebo, tras 24 semanas de admón. oral de tto. doble ciego en pacientes con diabetes tipo 2 y ERC en estadio 3.

E.2.2

Secondary objectives of the trial

·To compare the mean percent change from baseline in total body weight, and to compare the mean change from baseline in fasting plasma glucose or seated systolic blood pressure between dapagliflozin 10 mg plus saxagliptin 2.5 mg and placebo. ·To compare the proportion of patients achieving a 30% reduction in Urine albumin-to-creatinine ratio or a reduction in HbA1c <7.0% between dapagliflozin 10 mg plus saxagliptin 2.5 mg and placebo. ·To compare the mean percent change from baseline in total body weight and to compare the mean change from basleine in seated systolic blood pressure, HbA1c, or fasting plasma glucose between dapagliflozin 10 mg and placebo. ·To compare the proportion of patients achieving a 30% reduction in Urine albumin-to-creatinine ratio or a reduction in HbA1c <7.0% between dapagliflozin 10 mg and placebo.

- Comparar el cambio medio porcentual respecto al momento basal en el peso corporal total, comparar el cambio medio respecto al mto. basal en la glucosa plasmática en ayunas (GPA) o comparar el cambio medio respecto al mto. basal en la presión arterial sistólica (PAS) en sedest. entre 10 mg de dapagliflozina más 2,5 mg de saxagliptina y placebo
- Comparar la proporción de pac. que logran una reduc. del 30 % del CACo o comparar la de pac. que logran una reduc. de HbA1c <7,0 % entre 10 mg de dapag. más 2,5 mg de saxag. y placebo.
- Comparar el cambio medio porcentual respecto al mto. basal en el peso corporal total y comparar el cambio medio respecto al mto. basal en la presión art. sist.(PAS) en sedest., HbA1c, o en la gluc. plasmát. en ayunas (GPA) entre 10 mg de dapag. y placebo.
- Comparar la prop. de pac. que logran una reduc. del 30 % del CACo entre 10 mg de dapag. y placebo o comparar la prop. de pac. que logran una reduc. de la HbA1c <7,0 % entre 10 mg de dapag. y placebo.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Provision of informed consent prior to any study specific procedures 2. Female or male aged > o = 18 years and < 75 years. 3. History of type 2 diabetes mellitus for more than 12 months 4. Inadequate glycemic control, defined as HbA1c > o = 7.5% and < o = 10.5%. 5. Stable antidiabetic treatment during the last 12 weeks up to randomization.Stable antidiabetic treatment regimen, defined as: Stable diet and exercise therapy alone or in combination with any or both of the two following alternatives a.A regimen of any approved oral anti-diabetic medication (except SGLT2 inhibitors, GLP-1 receptor agonists and DPP4 inhibitors) where no dosechanges have occurred during the last 12 weeks up to randomization. b.Long acting or intermediate acting insulin and mixed insulin permitted as long as the dose is stable 12 weeks before randomization, changes ± 10% are allowed (in relation to number of units at randomization). 6. Renal impairment defined as eGFR 30 - 59 mL/minute/1.73 m^2, inclusive. 7. Micro or macroalbuminuria (UACR 30 - 3500 mg/g, inclusive). 8. Patient must be receiving an angiotensin converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB) for at least 3 months prior to screening, where the dose of the ACE inhibitor or the ARB is considered appropriate for that patient, and has been stable and maintained on that dose for at least 4 weeks prior to study randomization.
9. Body mass index between 20 and 40 kg/m^2, inclusive.

1. Firma del consentimiento informado con anterioridad a la realización de cualquiera de los procedimientos específicos del ensayo.
2. Mujer o varón de > o = 18 años y <75 años en la visita 1.
3. Antecedentes de DMT2 durante más de 12 meses.
4. Control glucémico inadecuado, definido como HbA1c > o = 7,5 % y < o = 10,5 % medida en la visita 1.
5. Tratamiento antidiabético estable durante las últimas 12 semanas previas a la aleatorización
La pauta de tratamiento antidiabético estable se define como: tratamiento con dieta estable y ejercicio solo o en combinación con cualquiera de las dos siguientes alternativas o con ambas:
a. Un régimen de cualquier medicación antidiabética oral aprobada (salvo inhibidores de SGLT2, agonistas del receptor de GLP-1 e inhibidores de DPP4) en la que no se hayan producido cambios en la dosis durante las 12 semanas anteriores a la aleatorización.
b. Se permite el uso de insulina de acción larga o intermedia e insulina mixta siempre que la dosis sea estable durante las 12 últimas semanas antes de la aleatorización, se permiten cambios de ±10 % (en relación con el número de unidades en la aleatorización).
6. La insuficiencia renal se define como una TFGe de 25-64 ml/minuto/1,73 m2, ambos inclusive, en la visita 1 y 30-59 ml/minuto/1,73 m2, ambos inclusive, en la visita 2 (para el cálculo de la TFGe, véase la sección 5.2.1).
7. Micro- o macroalbuminuria (CACo 30-3500 mg/g, ambos inclusive) en la visita 1.
8. El paciente debe recibir tratamiento con inhibidores de la enzima convertidora de la angiotensina (iECA) o bloqueantes del receptor de la angiotensina II (BRA) durante al menos 3 meses antes de la selección, en el que la dosis del inhibidor ECA o del BRA se considere apropiada para dicho paciente y el paciente se haya mantenido estable en esa dosis durante al menos 4 semanas antes de la aleatorización para el ensayo.
9. Índice de masa corporal entre 20 y 40 kg/m2, ambos inclusive.

E.4

Principal exclusion criteria

Main exclusion criteria are:- History of ?2 major hypoglycaemic events in the 3 months prior to enrolment visit, defined as symptomatic events
requiring external assistance due to severe impairment in consciousness or behaviour, with blood glucose level <3.0 mmol/L, <54 mg/dL (plasma glucose level <3.5 mmol/L, <63 mg/dL) and prompt recovery after glucose or glucagon administration.- Patients with Type 1 DM, history of diabetes insipidus, diabetic ketoacidosis, hyperosmolar nonketotic coma- Severe uncontrolled hypertension or any CV/Vascular Diseases within 3 month prior to signing the following: - Myocardial infarction. - Cardiac surgery or revascularization.- Unstable angina.- Unstable heart failure.- HF
New York Heart Association Class III-IV.- Transient ischemic attack or
significant cerebrovascular disease.- Unstable or previously undiagnosed arrhythmia.-Significant hepatic disease, severe hepatobiliary disease or hepatotoxicity with any medication- History of haemoglobinopathy or acute kidney injury requiring renal replacement therapy or any biopsy or imaging verifying intercurrent kidney disease other than diabetic nephropathy or diabetic nephropathy with nephrosclerosis.- History of unexplained microscopic or gross haematuria, or microscopic haematuria, confirmed by a follow-up sample at next scheduled visit- Treatment with a SGLT2 inhibitor, GLP-1 agonist or DPP4 inhibitors.- Simultaneous treatment with both an ACEi and an ARB- A metformin dose which is outside the specified dose range for moderate renal impairment (eGFR 30-59 mL/minute/1.73 m^2,) according to local guidelines and investigators judgement.- Any condition which, in the ju gment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk or suspected risk to the patient or with confirmed poor protocol or medication compliance - Patients at risk for volume depletion as judged by the investigator.

1. Antecedentes de ?2 acontecimientos hipoglucémicos importantes en los 3 meses previos a la visita de inclusión (visita 1), definidos como acontecimientos sintomáticos que requieren asistencia externa debido a una afectación grave de la consciencia o el comportamiento, con un nivel de glucosa en sangre <3,0 mmol/l, <54 mg/dl (nivel de glucosa plasmática <3,5 mmol/l, <63 mg/dl) y una pronta recuperación tras la administración de glucosa o glucagón.
2. Pacientes con DM tipo 1
3. Antecedentes de diabetes insípida, cetoacidosis diabética o coma hiperosmolar no cetósico.
4. Hipertensión no controlada grave
5. Cualquiera de las siguientes enfermedades CV/vasculares en el plazo de 3 meses antes de la firma del consentimiento en la visita 1:
-Infarto de miocardio.
-Cirugía cardíaca o revascularización (IDAC/ACTP).
-Angina inestable.
-Insuficiencia cardíaca (IC) inestable.
-IC de clase III-IV según la New York Heart Association (NYHA).
-Accidente isquémico transitorio (AIT) o enfermedad cerebrovascular importante.
- Arritmia inestable o sin diagnosticar previamente.
6. Enfermedad hepática significativa, incluidas, entre otras, hepatitis activa crónica y/o insuficiencia hepática grave.
7. Antecedentes documentados de hepatotoxicidad con cualquier medicación.
8. Antecedentes de hemoglobinopatía o hemólisis crónica o recurrente.
9. Antecedentes de lesión renal aguda que requiera terapia de sustitución renal (diálisis o ultrafiltración) o cualquier biopsia o estudio de imagen que confirme una enfermedad renal intercurrente distinta de la nefropatía diabética o la nefropatía diabética con nefroesclerosis.
10. Antecedentes de hematuria microscópica o macroscópica inexplicada o hematuria microscópica en la visita 1, confirmada por una muestra de seguimiento en la siguiente visita programada.
11. Tratamiento con un inhibidor de SGLT2, agonista de GLP-1 o inhibidores de DPP4
12. Tratamiento simultáneo con iECA y un BRA.
13. Una dosis de metformina que esté fuera del intervalo de dosis especificado para la insuficiencia renal moderada (TFGe 30?59 ml/minuto/1,73 m2,) según las directrices locales y el juicio del investigador.
14. Cualquier enfermedad que, a juicio del investigador, podría hacer que el paciente fuese incapaz de finalizar el ensayo o que pudiera suponer un riesgo significativo para el paciente o si se sospecha o se confirma que el paciente no cumple adecuadamente con el protocolo o la medicación.
15. Pacientes con riesgo de hipovolemia a juicio del investigador.

E.5 End points

E.5.1

Primary end point(s)

Outcome Measure for the Saxagliptin/Dapagliflozin treatment
arm?Change from baseline in HbA1c at Week 24.- Percent change from
baseline in UACR at Week 24 Outcome Measure for the Dapagliflozin
treatment arm.- Percent change from baseline in UACR at Week 24

Cambio en la HbA1c respecto al momento basal en la semana 24.
Cambio porcentual en el CACo respecto al momento basal en la semana 24, en el brazo de combinación Saxagliptina/ Dapagliflozina.
Cambio porcentual en el CACo respecto al momento basal en la semana 24, en el brazo de tratamiento de Dapagliflozina.

E.5.1.1

Timepoint(s) of evaluation of this end point

Baseline to end of treatment

Momento basal hasta el final del tratamiento.

E.5.2

Secondary end point(s)

Outcome Measure for the Saxagliptin/Dapagliflozin treatment arm: 1.
Percent change from baseline in total body weight at Week 24 2. Change from baseline in FPG at Week 24 3. 30% reduction in UACR at Week 24 4. HbA1c < 7.0 % at Week 24 5. Change from baseline in seated SBP at Week 24 Outcome Measure for the Dapagliflozin treatment arm: 1. Percent change from baseline in total body weight at Week 24 2. 30% reduction in UACR at Week 24 3. Change from baseline in seated SBP at Week 24 4. Change from baseline in HbA1c at Week 24 5. Change from baseline in FPG at Week 24 6. HbA1c < 7.0 % at Week 24

Variables secundarias de resultados para las comparaciones de tratamiento con saxagliptina/dapagliflozina:

1. Cambio porcentual respecto al momento basal en el peso corporal (kg) en la semana 24
2. Cambio respecto al momento basal en la GPA (mg/dl) en la semana 24.
3. Reducción del 30 % en el CACo en la semana 24.
4. HbA1c <7,0 % en la semana 24.
5. Cambio respecto al momento basal en la PAS en sedestación (mmHg) en la semana 24.
Variables secundarias de resultados para las comparaciones de tratamiento con dapagliflozina:

1. Cambio porcentual respecto al momento basal en el peso corporal (kg) en la semana 24.
2. Reducción del 30 % en el CACo en la semana 24.
3. Cambio respecto al momento basal en la PAS en sedestación (mmHg) en la semana 24.
4. Cambio respecto al momento basal en la HbA1c (%) en la semana 24.
5. Cambio respecto al momento basal en la GPA (mg/dl) en la semana 24.
6. HbA1c <7,0 % en la semana 24.

E.5.2.1

Timepoint(s) of evaluation of this end point

Baseline to the end of treatment

Momento basal al finalizar el tratamiento.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

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

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)

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

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

Australia

Canada

Japan

Mexico

Spain

Taiwan

United States

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

Last Patient Last Visit

Última visita del último paciente

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

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:

225

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

225

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

225

F.4.2

For a multinational trial

F.4.2.1

In the EEA

225

F.4.2.2

In the whole clinical trial

1125

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. Standard Routine Medical Care

Ninguno. Cuidados médicos rutinarios.

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2015-11-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-11-16

P. End of Trial
P.	End of Trial Status	Completed

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IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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