E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pulmonary artery hypertension and thromboembolic chronic pulmonary hypertension |
Hipertensión arterial pulmonar e hipertensión pulmonar tromboembólica crónica |
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E.1.1.1 | Medical condition in easily understood language |
Pulmonary artery hypertension and thromboembolic chronic pulmonary hypertension |
Hipertensión arterial pulmonar e hipertensión pulmonar tromboembólica crónica |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037405 |
E.1.2 | Term | Pulmonary hypertension primary |
E.1.2 | System Organ Class | 100000004855 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10068739 |
E.1.2 | Term | Chronic thromboembolic pulmonary hypertension |
E.1.2 | System Organ Class | 100000004855 |
|
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
to identify cell proliferation processes in patients with severe forms of pulmonary hypertension |
identificar procesos de proliferación celular en pacientes con formas graves de hipertensión pulmonar |
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E.2.2 | Secondary objectives of the trial |
Safety of FDG PET miRNA study cell line characterization |
Seguridad del PET con FDG estudio de miRNAs caracterización de líneas celulares |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male and female Age 18-75 Patients with precapillary pulmonary hypertension Healthy subjects with normal lung function |
Ambos sexos edad entre 18 y 75 Pacientes con hipertensión pulmonar precapilar Sujetos sanos con función respiratoria normal |
|
E.4 | Principal exclusion criteria |
Severe comorbidities. ? Lung disease or condition interfering with FDG-PET image acquisition ? Active cancer except basocellular skin carcinoma ? Current smokers - Pregnancy or breastfeeding Hyperglycaemia (above 200 mg/dL) - Hypersensitivity to FDG or excipients. |
Presencia de comorbilidad grave. ? Enfermedad pulmonar, pleural o de la caja torácica que pueda interferir con las mediciones mediante PET-FDG. ? Presencia de neoplasia activa, excepto carcinoma basocelular ? Fumadores o exfumadores de menos de 10 años o con dosis acumulada superior o igual a 10 paquetes-año. - Mujeres embarazadas o en período de lactancia Hiperglucemia (glucemia basal superior a 200 mg/dL) - Hipersensibilidad al principio activo o alguno de los excipientes. |
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E.5 End points |
E.5.1 | Primary end point(s) |
FDG uptake per volume unit (standardized uptake valueSUV) |
Captación de FDG por unidad de volumen pulmonar (valor estandarizado de captación) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Adverse event number Serious adverse event number |
Número de Acontecimientos adversos (AA) Número de acontecimientos adversos graves (AAG) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
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 | 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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | No |
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
|
LVLS |
última visita del último sujeto |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
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 | 3 |