E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
EPOC e hipertensión pulmonar asociada |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10010952 |
E.1.2 | Term | COPD |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037406 |
E.1.2 | Term | Pulmonary hypertension secondary |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Valorar la eficacia (descenso de la presión de arteria pulmonar) y seguridad (posible empeoramiento del intercambio gaseoso) de la administración de 20 ó 40 mg de sildenafilo, en reposo y durante el esfuerzo, en pacientes con enfermedad pulmonar obstructiva crónica (EPOC) e hipertensión pulmonar. |
|
E.2.2 | Secondary objectives of the trial |
Evaluar los efectos del sildenafilo en la disfunción eréctil de los pacientes con EPOC |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
EPOC grave o muy grave (estadíos 3-4 de la clasificación GOLD) Hipoxemia (PaO2 <70 mmHg) Hipertensión pulmonar, evaluada mediante ecocardiografía, y definida por una velocidad pico de regurgitación tricuspídea ≥2.8 m/s, en reposo o durante la realización de esfuerzo. Consentimiento de participar en el estudio
|
|
E.4 | Principal exclusion criteria |
Enfermedad pulmonar o extrapulmonar que pueda interferir en el intercambio de gases o la hemodinámica pulmonar Pacientes en tratamiento con vasodilatadores Pacientes que tomen inhibidores de la fosfodiesterasa-5 regularmente Pacientes con cardiopatía isquémica Enfermedad sistémica grave que pueda interferir en la interpretación de los resultados Pacientes con incapacidad para realizar un esfuerzo en cicloergómetro.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Las principales variables del estudio serán: la presión media de la arteria pulmonar (PAP), como índice de eficacia; y la presión parcial de oxígeno en sangre arterial (PaO2) y los índices de dispersión de las distribuciones VA/Q (logSD Q y logSD V), como indicadores de seguridad. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
diferente dosis del mismo producto |
|
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 | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
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 | No |
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 | 1 |
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 | 1 |