Clinical Trials Register

Summary
EudraCT Number:	2009-011441-11
Sponsor's Protocol Code Number:	LAICA/09
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2009-06-26
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

Spain - AEMPS

A.2

EudraCT number

2009-011441-11

A.3

Full title of the trial

Estudio Randomizado Doble Ciego y Controlado con Placebo Para Evaluar la Eficacia y Seguridad de la Administración Intermitente y a Largo Plazo de Levosimendan en Pacientes con Insuficiencia Cardiaca Avanzada (Estudio LAICA).

A.3.2

Name or abbreviated title of the trial where available

LAICA

A.4.1

Sponsor's protocol code number

LAICA/09

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Dr. Francisco Marrero Rodríguez. Hospital Universitario de Canarias
B.1.3.4	Country	Spain
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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	SIMDAX 2,5 mg/ml concentrado para solución para perfusión
D.2.1.1.2	Name of the Marketing Authorisation holder	ABBOTT LABORATORIES, S.A.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Simdax
D.3.2	Product code	64154
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LEVOSIMENDAN
D.3.9.1	CAS number	141505-33-1
D.3.9.3	Other descriptive name	LEVOSIMENDAN
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
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)	Information not present in EudraCT
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	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	Information not present in EudraCT
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	Information not present in EudraCT
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	Solution for infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Insuficiencia Cardiaca avanzada

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9
E.1.2	Level	LLT
E.1.2	Classification code	10019282
E.1.2	Term	Heart failure (NOS)

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Objetivo Principal: evaluar la incidencia de admisión o ingreso por empeoramiento o descompensación de la IC en pacientes con IC avanzada, definida ésta como primera admisión a servicios de urgencia o ingreso hospitalario mayor de 12 horas debidos a un empeoramiento de los síntomas de IC.

E.2.2

Secondary objectives of the trial

•Tiempo contabilizado como días transcurridos desde la randomización hasta la primera hospitalización por descompensación de insuficiencia cardiaca, definida ésta como admisión a servicios de urgencia o ingreso hospitalario mayor de 12 horas debidos a un empeoramiento de los síntomas de insuficiencia cardíaca.
•Mortalidad por cualquier causa.
•Eventos Cardiacos Mayores (Muerte Súbita, Isquemia Coronaria/Infarto de miocardio, Descompensación de IC y ACV).
•Muerte súbita.
•ACV.
•Acontecimientos adversos graves.
•Cambio en la escala NYHA antes y después del inicio del tratamiento 30 días, 6 y 12 meses.
•Efectos sobre la activación neurohormonal e inflamatoria en la IC (niveles de NT-proBNP; citocinas, etc).
•Identificar los factores asociados a una mejor supervivencia de los pacientes.
•Calidad de vida.
•Relación Costes- Efectividad del Tratamiento.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

a)Edad mayor de 18 años
b)Síntomas severos de IC con disnea y/o astenia en reposo o a mínimos esfuerzos (Clase funcional III y IV de la NYHA)
c)Episodios de retención de líquidos (congestión venosa sistémica o pulmonar, edemas periféricos) y/o de bajo gasto cardiaco en reposo (hipoperfusión periférica)
d)Evidencias objetivas de disfunción cardíaca severa determinada por la presencia de al menos uno de los siguientes:
–Fracción de eyección ventricular izquierda  30%
–Una alteración severa de la función cardíaca en la ecocardiografía doppler con un patrón de flujo transmitral pseudonormal o restrictivo.
–Una presión de llenado ventricular izquierdo elevada (PCP > 16 mmHg y/o PAD media > 12 mmHg por cateterización de la arteria pulmonar)
–Niveles de BNP o NT-ProBNP elevados en ausencia de causas no cardíacas para ello.
e)Alteración severa de la capacidad funcional puesta de manifiesto por uno de los siguientes:
–Incapacidad para el ejercicio
–Una distancia <300 m o inferior en mujeres y/o pacientes 75 años en el test de caminar 6 minutos
–Un test de consumo miocárdico de oxígeno < 12-14 ml/kg/min.
f)Historia previa de  1 hospitalización por IC en los 6 meses previos
g)Presencia de todos los anteriores criterios a pesar de los intentos de optimizar el tratamiento incluyendo diuréticos, inhibidores del sistema renina-angiotensina-aldosterona y betabloqueantes, a menos que estos fármacos no fuesen tolerados o estuviesen contraindicados, así como el tratamiento de resincronización cardíaca cuando estuviera indicado.
h)Que consientan participar en el estudio.

E.4

Principal exclusion criteria

a)Alergia o hipersensibilidad a Levosimendan u otros componentes de Simdax®.
b)Insuficiencia renal severa (aclaramiento de creatinina < 30 ml/min)
c)Insuficiencia hepática severa.
d)Historia de enfermedad autoinmune.
e)Embarazo.
f)Mujeres en edad fértil que no utilicen métodos anticonceptivos adecuados
g)(hormonales, D.I.U., barrera + espermicida)
h)Enfermedades cardíacas con obstrucciones significativas al llenado o vaciado ventricular.
i)Hipotensión arterial grave (Presión Arterial Sistólica  90 mmHg).
j)Presencia de taquicardia >120 lpm o historia previa de Torsades de Pointes.
k)Enfermedad concomitante severa con pronóstico disminuido a corto plazo.
l)Incapacidad para dar consentimiento informado.
m)Participación en otro estudio.

E.5 End points

E.5.1

Primary end point(s)

La variable principal del estudio es determinar la incidencia de admisión o ingreso por empeoramiento o descompensación de la IC en pacientes con IC avanzada. Se define ésta como admisión a servicios de urgencia o ingreso hospitalario mayor de 12 horas debidos a un empeoramiento de los síntomas y signos de IC.

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

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

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

Information not present in EudraCT

E.7.1.2

Bioequivalence study

Information not present in EudraCT

E.7.1.3

Other

Information not present in EudraCT

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

Yes

E.8.2.3

Other

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.8.5

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

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

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1.1	In Utero	Information not present in EudraCT
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	Information not present in EudraCT
F.1.1.3	Newborns (0-27 days)	Information not present in EudraCT
F.1.1.4	Infants and toddlers (28 days-23 months)	Information not present in EudraCT
F.1.1.5	Children (2-11years)	Information not present in EudraCT
F.1.1.6	Adolescents (12-17 years)	Information not present in EudraCT
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	213

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

2009-09-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2009-03-30

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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