E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pacientes con Hipotiroidismo Subclínico (HS) leve y riesgo cardiovascular moderado/alto. |
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MedDRA Classification |
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 |
Determinar los efectos del tratamiento con tiroxina 0,8-1,6 microgramos/kg/día sobre los niveles de tensión arterial, grosor de la íntima media y función miocárdica en pacientes con Hipotiroidismo Subclínico leve y riesgo cardiovascular moderado/alto, después de 48 semanas de tratamiento. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Hombres o mujeres (no fértiles o físicamente fértiles que utilicen un método anticonceptivo clínicamente aprobado), con edades entre 30 y 75 años de edad. -Pacientes diagnosticados de hipotiroidismo subclínico leve, de acuerdo con la documentación de niveles séricos de TSH ≥ 5 y ≤10 mU/l y T4 libre normal, en al menos dos ocasiones espaciadas por tres semanas. |
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E.4 | Principal exclusion criteria |
-Enfermedad tiroidea previamente tratada (antitiroideos, tiroxina, tiroidectomía o radioiodo). -Patologías que puedan producir disfunción hipotálamo-hipofisaria. -Tratamiento con fármacos que puedan afectar la función tiroidea (amiodarona, litio, interferón). -Gestación.Lactancia -Mujeres en evaluación por infertilidad. -Sintomatología franca de hipotiroidismo. -Insuficiencia renal crónica en estadios 4 y 5 (filtrado glomerular <30 ml/min). -Insuficiencia hepática o hepatopatía (aumento de transaminasas > 2 veces el límite superior de la normalidad). -Enfermedad celiaca. -Evento coronario o cerebrovascular previos al inicio del estudio. -Neoplasia activa. -IMC ≤18,5 y ≥40 Kg/m2. |
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E.5 End points |
E.5.1 | Primary end point(s) |
T4l T3 AcTPO COL HDL LDL noHDL Triglicéridos creatinina Ac. úrico PCR: Proteína C reactiva Na orina 24h Coc alb/creat Peso Masa magra Masa grasa GIMccd: grosor íntima media carótida común derecha. GIMcci: grosor íntima media carótida común izquierda. Diámetro VI (ventriculo izquierdo) GTI-grosor tabique interauricular GPP-grosor pared posterior Masa VI FxVS FxVD Tensión Arterial media diurna Tensión Arterial media nocturna Frecuencia cardiaca media |
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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 | No |
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 | 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 | Yes |
E.8.1.3 | Single blind | No |
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 |
Se comprara con no administrar fármaco |
|
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 | 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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |