Calendario›LXRX›Sotagliflozin
Sotagliflozin
Safety, Tolerability and Pharmacodynamic Activity of Sotagliflozin in Hemodynamically Stable Participants With Worsening Heart Failure
Ensayo de LEXICON PHARMACEUTICALS, INC. en Cardiac Failure Aggravated (del registro, en inglés).
- Fase
- Fase 2
- Estado
- Interrumpido
- Participantes
- 32
- Centros
- 6
- Fin del objetivo primario
- ago 2019
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en dic 2017.
Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «1st two cohorts provided the required data, therefore 3rd cohort was not deemed necessary».
Qué mide
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), AEs Leading to Discontinuation From the Investigational Medicinal Product (IMP) and Deaths (Baseline up to Day 14) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary Objectives: * Assess the safety and tolerability of sotagliflozin in hemodynamically stable participants with worsening of heart failure, compared to placebo. * Estimate the effects of sotagliflozin on plasma volume changes in hemodynamically stable participants with worsening of heart failure, compared to placebo. Secondary Objectives: * Explore the effect of sotagliflozin on erythropoiesis, as assessed by changes in plasma erythropoietin levels, in hemodynamically stable participants with worsening of heart failure, compared to placebo. * Explore the effect of sotagliflozin on changes in plasma N-terminal prohormone of brain natriuretic peptide (NT-proBNP) levels, in hemodynamically stable participants with worsening of heart failure, compared to placebo.
Más ensayos de LXRX
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| Sotagliflozin · SONATA-HCM | Fase 3 | En marcha, sin reclutar | ene 2027 (prevista) |
| LX9211 · PROGRESS | Fase 2 | Completado | ene 2025 (real) |
| LX9211 · RELIEF-PHN1 | Fase 2 | Completado | nov 2022 (real) |
| LX9211 · RELIEF-DPN 1 | Fase 2 | Completado | may 2022 (real) |
| Sotagliflozin · SCORED | Fase 3 | Interrumpido | jul 2020 (real) |
| Sotagliflozin | Fase 3 | Interrumpido | jun 2020 (real) |
Todos los de LXRX, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT03292653), actualizada en abr 2021.