Clinical Trials Register

Summary
EudraCT Number:	2009-016595-77
Sponsor's Protocol Code Number:	PTF-AAS-TR-2009
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2009-12-15
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2009-016595-77

A.3

Full title of the trial

Efecto de la combinación estatinas-aspirina versus estatinas-pentoxifilina sobre la lesión aterosclerótica en pacientes con enfermedad renal crónica.

A.3.2

Name or abbreviated title of the trial where available

Pentoxifil

A.4.1

Sponsor's protocol code number

PTF-AAS-TR-2009

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	Juan Francisco Navarro González
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	Information not present in EudraCT
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	Pentoxifilina
D.3.2	Product code	PTF
D.3.4	Pharmaceutical form	Prolonged-release tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	Pentoxifilina
D.3.9.1	CAS number	6493-05-6
D.3.9.2	Current sponsor code	PTF
D.3.9.3	Other descriptive name	Pentoxifilina
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	600
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.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	Information not present in EudraCT
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	Acido acetilsalicílico
D.3.2	Product code	AAS
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	Acido acetilsalicílico
D.3.9.1	CAS number	50-78-2
D.3.9.2	Current sponsor code	AAS
D.3.9.3	Other descriptive name	Aspirina
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	100
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Enfermedad aterosclerótica en la Enfermedad renal crónica

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Analizar en pacientes con enfermedad renal crónica, las propiedades anti-ateroscleróticas de 3 regímenes de tratamiento: estatinas, estatinas combinadas con AAS y estatinas combinadas con PTF, mediante la evaluación del grosor íntima-media carotídeo.

E.2.2

Secondary objectives of the trial

·Analizar la potencial repercusión clínica de estos regímenes terapéuticos mediante la evaluación del índice tobillo-brazo.
·Estudiar la relación de las concentraciones séricas de biomarcadores inflamatorios con la severidad de la lesión aterosclerótica y su modificación con los regímenes terapéuticos utilizados.
·Analizar la expresión de genes de citoquinas pro- y anti-inflamatorias en células mononucleares de sangre periférica y evaluar su relación con la severidad de la lesión aterosclerótica y su modificación con el tratamiento.
·Estudiar diversos polimorfimos genéticos de estas citoquinas para valorar su potencial relación con la severidad de la lesión y la respuesta al tratamiento.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Edad superior a 18 años.
2.ERC estadio 3 ó 4 (FG estimado mediante la expresión MDRD-4 entre 15 y 60 ml/min).
3.Presión arterial (PA) < 140/90 mmHg.
4.Ausencia de antecedentes clínicos de ECV.
5.Tratamiento con estatinas al menos durante los 6 meses previos a la inclusión en el estudio.
6.Ausencia de terapéutica inmunosupresora en los 6 meses previos a la inclusión en el estudio.
7.Obtención del consentimiento del paciente.

E.4

Principal exclusion criteria

1.ECV previa (angina o infarto agudo de miocardio, accidente isquémico transitorio, infarto cerebral isquémico y/o hemorrágico, claudicación intermitente).
2.Enfermedad intercurrente que presuponga ausencia de seguimiento o expectativa de supervivencia menor a 1 año, a juicio del investigador.
3.Cirugía previa de las arterias carótidas.
4.Haber recibido previamente un trasplante de órganos.
5.HTA no controlada, definida como una PA sistólica mayor o igual a 140 mmHg y/o una PA diastólica mayor o igual a 90 mmHg).
6.Padecer enfermedades sistémicas (LES, vasculitis, amiloidosis, etc) o tumorales.
7.Agudización de la IR crónica por proceso intercurrente en los últimos 6 meses.
8.Necesidad de tratamiento concomitante con glucocorticoides o antiinflamatorios no esteroideos en los 3 meses previos a la inclusión en el estudio.
9.Mujeres en edad fértil que no utilicen medidas anticonceptivas.
10.Mujeres en período de lactancia.
11.Aquellos casos en los que el AAS esté contraindicado según ficha técnica (úlcera gastroduodenal activa, crónica o recurrente, y molestias gástricas de repetición; antecedentes de hemorragia o perforación gástrica tras el tratamiento con ácido acetilsalicílico u otros antiinflamatorios no esteroideos; asma; historial de hipersensibilidad a ácido acetilsalicílico, a antiinflamatorios no esteroideos o a tartrazina (reacción cruzada); enfermedades que cursen con trastornos de la coagulación, principalmente, hemofilia o hipoprotrombinemia; insuficiencia hepática grave; pólipos nasales asociados a asma que sean inducidos o exacerbados por ácido acetilsalicílico).
12.Aquellos casos en los que el AAS esté contraindicado según ficha técnica ((hipersensibilidad a la pentoxifilina o a otras metilxantinas; hemorragia grave; hemorragia retiniana extensa (riesgo de aumento de la hemorragia); infarto de miocardio reciente).

E.5 End points

E.5.1

Primary end point(s)

Grosor del complejo íntima-media carotídeo, siendo considerado éste como la distancia entre la línea ecogénica interna, que representa la interfase luz vascular-íntima, y la línea ecogénica externa, que representa la interfase de la adventicia media, en la vista longitudinal de la carótida mediante ecografía.

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

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

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

Sin tratamiento experimental

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

El ensayo finalizará con la última visita del último sujeto incluido en el ensayo.

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	101

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

2010-03-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-01-28

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

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials