Calendario›SNY›FAST
FAST
Study to Assess Safety and Efficacy of Fexofenadine Hydrochloride (HCL) + Pseudoephedrine HCL Fixed Dose Combination in Indian Male and Female Participants With Allergic Rhinitis (AR) Who Are 12 Years and Above
Ensayo de Sanofi en Rhinitis Allergic (del registro, en inglés).
- Fase
- Fase 4
- Estado
- Completado
- Participantes
- 203
- Centros
- 11
- Fin del objetivo primario
- dic 2025
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, de un solo grupo, abierto. Comenzó en jun 2025.
Qué mide
Number of participants with treatment-emergent adverse events (TEAEs) (del registro, en inglés) (del dia 1 al dia 16)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis is a single group, Phase IV clinical trial to assess the safety and effectiveness of Allegra® D. This study will be conducted in participants with allergic rhinitis who are 12 years of age and above. The individual study duration for each participant would be approximately 16 days (maximum of 13 days intervention + a 3-day post intervention observation). There would be 4 study visits in which the last visit can be done either telephonically or on site. Safety events would be captured for the entire study duration. In addition, the effectiveness of the study drug would be assessed using Nasal symptom score (NSS) and Total symptom score (TSS).
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT05720455), actualizada en feb 2026.