E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
pacientes normotensos con tromboembolia de pulmón aguda. |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10014521 |
E.1.2 | Term | pulmonary embolism |
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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 |
Demostrar los beneficios clínicos de tenecteplasa con respecto al placebo en pacientes normotensos con tromboembolia de pulmón aguda y disfunción del ventrículo derecho. |
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E.2.2 | Secondary objectives of the trial |
Evaluar la seguridad tras la administración de tenecteplasa en pacientes normotensos con tromboembolia de pulmón aguda y evidencia ecocardiográfica (o TAC helicoidal) y bioquímica de disfunción del ventrículo derecho. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-18 años de edad o mayores -TEP aguda (presentándose los primeros síntomas 15 días o menos antes de la aleatorización) -disfunción del ventrículo derecho confirmada mediante ecocardiografía o tomografía computerizada helicoidal del tórax y un resultado positivo en el análisis de la troponina (I o T). -Troponina I > 0,06 µg/L o troponina T > 0,01 µg/L utilizando la prueba del Departamento de Bioquímica Clínica en el centro participante |
|
E.4 | Principal exclusion criteria |
-Colapso hemodinámico -Riesgo conocido de sangrado significativo -Administración de fármacos trombolíticos en los 4 días anteriores a la inclusión -hipertensión no controlada -sistólica > 180 mmHg -y/o disastólica > 110 mmHg -Ausencia de eficacia contraceptiva en mujeres en edad de procrear
-Mujeres embarazadas -Trastorno de la coagulación conocido (incluidos los antagonistas de la vitamina K y el recuento de plaquetas < 100 000/mm3) |
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E.5 End points |
E.5.1 | Primary end point(s) |
-La variable clínica compuesta principal es la eficacia frente a mortalidad por todas las causas o colapso hemodinámico en los primeros 7 días -Las variables secundarias de este estudio son: ? Muerte en los primeros 7 días ? Colapso hemodinámico en los primeros 7 días ? Recaída confirmada de tromboembolia de pulmón sintomática en los primeros 7 días ? Muerte en los primeros 30 días
-Los criterios de seguridad para este estudio son: ? Ictus (hemorragia intracraneal o ictus isquémico) en los primeros 7 días ? Sangrado mayor (distinto a HIC) en los primeros 7 días |
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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 | No |
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 | 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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | No |
E.8.1.4 | Double blind | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
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 | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 88 |
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 | Information not present in EudraCT |
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 |
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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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |