Fiche traitement
valsartan
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University • Hypertension
Suivi actif
Phase 3
Résumé
valsartan est développé par Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Le traitement est actuellement en Phase 3. Il est associé à Hypertension. Son objectif thérapeutique principal est À vérifier. Le statut actuel est : suivi actif.
À vérifier
À vérifier
Phase 3
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
China
This multicentre, prospective, single-arm cohort study will evaluate the real-world effectiveness and safety of Savagen, an NPRA-approved generic sacubitril/valsartan, in Malaysian adults aged 18 to 70 years with heart failure with reduced ejection fraction (HFrEF; LVEF ≤40%, NYHA class II-III). Approximately 80 patients initiating Savagen as part of routine clinical care at hospitals offering a Heart Failure Medication Therapy Adherence Clinic (HFMTAC) will be followed for 12 months. The primary outcome is the change in NT-proBNP from baseline to 12 months. Secondary outcomes include changes in LVEF, renal function (serum creatinine, eGFR), serum potassium, patient-reported health status (KCCQ) and dietary diversity (Dietary Diversity Score), a composite of cardiovascular death or first heart failure hospitalisation, and adverse events, including hypotension, hyperkalaemia, renal impairment and angioedema. The study does not aim to establish equivalence with the reference product; it will generate local real-world evidence on the effectiveness, tolerability, safety and patient-reported outcomes of generic sacubitril/valsartan in routine Malaysian HFrEF care.
2022-09-16
Début phase actuelle
Non disponible dans les sources synchronisées
Timeline clinique
Phase 3
Début phase actuelle
Non disponible dans les sources synchronisées
Préclinique
Phase 1
Phase 2
Phase 3
Approuvé
Objectif scientifique de l’étude
classification automatique vérifiable
À vérifier
Confiance automatique : 0%
Ce pourcentage n’est pas une probabilité de succès clinique.
Il mesure uniquement la force de la classification automatique de l’objectif scientifique. Le calcul part de 45 points, ajoute 7 points par unité de poids du mot-clé le plus fortement détecté, puis est plafonné à 95 %. Exemple : un score maximal de 2 donne 45 + (2 × 7) = 59 %.
Ce score est heuristique et doit être vérifié dans le protocole ou une publication.
Description affichée depuis l’essai compatible NCT07907640, afin d’éviter le mélange entre plusieurs indications d’une même molécule.
Contrôle de cohérence : 85/100
L’objectif est absent ou classé « Autre » et doit être recalculé à partir du protocole.
Transparence et qualité de la fiche
données vérifiablesClassificationÀ vérifier
Confiance de la fiche85 %
Source principaleSource officielle ou publication indexée
Dernière vérification2022-09-16
Anomalies détectées1
Validation humaineValidation humaine non effectuée
Donnée issue d’une source
Donnée normalisée automatiquement
Interprétation algorithmique
Classification scientifique multi-axes
ne pas confondre statut et résultatÉtat de l’étudeRecrutement en cours
Disponibilité des résultatsRésultats à vérifier
InterprétationImpossible à déterminer
Niveau de preuveNon évaluable
Un essai terminé n’est pas nécessairement positif. Un essai arrêté n’est classé comme échec scientifique que lorsqu’un résultat ou une raison explicite le confirme.
Indicateurs factuels
sans score subjectifPhase enregistréePhase 3
Études associées4
Publications associées18
Statut consolidéSuivi actif
Aucune chance de succès, note d’innovation, potentiel thérapeutique ou probabilité de commercialisation n’est calculé tant qu’un modèle validé et des données suffisantes ne sont pas disponibles.
Historique factuel de la molécule
31 événement(s) daté(s)Cette liste reprend uniquement les dates trouvées dans les registres et publications liés. Elle ne constitue pas une prévision.
| Date | Événement | Source |
|---|---|---|
| 2016-10-14 | Début de l’étudeNCT03536598 | Registre d’essai clinique |
| 2017-09-04 | Fin de l’étude prévue / enregistréeNCT03536598 | Registre d’essai clinique |
| 2022-09-16 | Dernière mise à jour des donnéesvalsartan | Biomedical Watch |
| 2022-09-24 | Début de l’étudeNCT05545059 | Registre d’essai clinique |
| 2023-01-31 | Début de l’étudeNCT06604897 | Registre d’essai clinique |
| 2023-03-31 | Fin de l’étude prévue / enregistréeNCT05545059 | Registre d’essai clinique |
| 2025-10-31 | Fin de l’étude prévue / enregistréeNCT06604897 | Registre d’essai clinique |
| 2026-07-24 | Création de l’enregistrementNCT03536598 | Registre d’essai clinique |
| 2026-07-29 | Création de l’enregistrementNCT05545059 | Registre d’essai clinique |
| 2026-08-08 | PublicationIn symptomatic HF, sacubitril-valsartan vs. dapagliflozin and torsemide vs. furosemide did not differ for health status at 6 mo. | Annals of internal medicine |
| 2026-08-08 | PublicationDose optimization of sacubitril/valsartan in Chinese chronic heart failure patients: integration of physiologically based pharmacokinetic modeling and real-world data. | Frontiers in pharmacology |
| 2026-08-08 | PublicationAdditive beneficial effects of valsartan combined with rosuvastatin in the treatment of hypercholesterolemic hypertensive patients. | Korean circulation journal |
| 2026-08-08 | PublicationEffect of Amlodipine/Nebivolol combination therapy on central BP and PWV compared to Amlodipine/Valsartan combination therapy. | The Egyptian heart journal : (EHJ) : official bulletin of the Egyptian Society of Cardiology |
| 2026-08-08 | PublicationEffect of Fixed-dose Combination Amlodipine/Valsartan in Comparison to Two Drug Combination Nebivolol/Valsartan on 24-Hour Ambulatory Blood Pressure. | Current hypertension reviews |
| 2026-08-08 | PublicationPharmacokinetic Drug Interactions Between Amlodipine, Valsartan, and Rosuvastatin in Healthy Volunteers. | Advances in therapy |
| 2026-08-13 | PublicationInnovative valsartan-loaded self-nanoemulsifying drug delivery system combat liver inflammation and oxidative stress in streptozotocin-induced diabetic rats. | Molecular and cellular biochemistry |
| 2026-08-16 | Création de l’enregistrementNCT06604897 | Registre d’essai clinique |
| 2026-08-16 | PublicationAcute myocardial infarction in a patient with HAM/TSP evaluated for circulatory dynamics during mobilization before and after antihypertensive drug modification: a case report. | Journal of medical case reports |
| 2026-08-16 | PublicationRandomized-controlled trial of sacubitril/valsartan and amlodipine combination in Japanese uncontrolled hypertensive patients (J-SAMIT). | Hypertension research : official journal of the Japanese Society of Hypertension |
| 2026-08-16 | PublicationPrescription patterns of sacubitril/valsartan among patients with hypertension in Japan. | Frontiers in cardiovascular medicine |
| 2026-08-16 | PublicationSacubitril/Valsartan versus Enalapril or Losartan at Maximum Doses in Heart Failure with Reduced Ejection Fraction: Real-World Data. | Arquivos brasileiros de cardiologia |
| 2026-08-16 | PublicationBiomarker-guided pharmacotherapy in cardiovascular-kidney-metabolic syndrome: A three-dimensional framework for precision drug selection and monitoring. | Pharmacology & therapeutics |
| 2026-08-16 | PublicationBibliometric analysis of sacubitril/valsartan in the management of chronic kidney disease (2013-2025). | Renal failure |
| 2026-08-16 | PublicationSpatially resolved label-free FTIR imaging reveals compartment-specific spectral signatures of cardiorenal crosstalk and their pharmacological modulation by Sacubitril/Valsartan. | Spectrochimica acta. Part A, Molecular and biomolecular spectroscopy |
| 2026-08-16 | PublicationA pharmacokinetic and pharmacodynamic drug interaction between rosuvastatin and valsartan in healthy subjects. | Drug design, development and therapy |
| 2026-08-16 | PublicationEffect of Amlodipine/Valsartan Versus Nebivolol/Valsartan Fixed Dose Combinations on Peripheral and Central Blood Pressure. | High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension |
| 2026-10-01 | Début de l’étudeNCT07907640 | Registre d’essai clinique |
| 2026-10-25 | PublicationAliskiren: a review of its use as monotherapy and as combination therapy in the management of hypertension. | Drugs |
| 2026-10-25 | PublicationSexual function among controlled and uncontrolled hypertensive females receiving beta-blockers or ACEI/ARB and thiazides: a prospective randomized controlled study. | Scientific reports |
| 2026-11-01 | Création de l’enregistrementNCT07907640 | Registre d’essai clinique |
| 2028-09-30 | Fin de l’étude prévue / enregistréeNCT07907640 | Registre d’essai clinique |
Début phase actuelle
Non disponible dans les sources synchronisées
Essais cliniques liés
4 essai(s)
Début phase actuelle
Non disponible dans les sources synchronisées
| NCT | Titre | Phase | Statut administratif | Pays | Sponsor |
|---|---|---|---|---|---|
| NCT07907640 | Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients | À vérifier | NOT_YET_RECRUITING | Malaysia | Sunway University |
| NCT06604897 | Effectiveness of Entresto (Sacubitril/Valsartan) in Japanese Patients With Hypertension | À vérifier | COMPLETED | United States | Novartis Pharmaceuticals |
| NCT05545059 | Effects and Safety of Sacubitril/Valsartan on Refractory Hypertension | Phase 3 | UNKNOWN | China | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
| NCT03536598 | Study to Evaluate the Safety and Efficacy of CJ-30060 in Hypertensive Patients With Hyperlipidemia | Phase 3 | COMPLETED | Non communiqué | HK inno.N Corporation |
Publications liées
18 publication(s)Publications liées
18 publication(s)| Titre | PMID | DOI | Journal | Date |
|---|---|---|---|---|
| Aliskiren: a review of its use as monotherapy and as combination therapy in the management of hypertension. Voir source | 20883056 | 10.2165/11204360-000000000-00000 | Drugs | |
| Sexual function among controlled and uncontrolled hypertensive females receiving beta-blockers or ACEI/ARB and thiazides: a prospective randomized controlled study. Voir source | 41844720 | 10.1038/s41598-026-40790-2 | Scientific reports | |
| Acute myocardial infarction in a patient with HAM/TSP evaluated for circulatory dynamics during mobilization before and after antihypertensive drug modification: a case report. Voir source | 42215977 | 10.1186/s13256-026-06045-4 | Journal of medical case reports | |
| Randomized-controlled trial of sacubitril/valsartan and amlodipine combination in Japanese uncontrolled hypertensive patients (J-SAMIT). Voir source | 42373836 | 10.1038/s41440-026-02704-7 | Hypertension research : official journal of the Japanese Society of Hypertension | |
| Prescription patterns of sacubitril/valsartan among patients with hypertension in Japan. Voir source | 42539654 | 10.3389/fcvm.2026.1738988 | Frontiers in cardiovascular medicine | |
| Sacubitril/Valsartan versus Enalapril or Losartan at Maximum Doses in Heart Failure with Reduced Ejection Fraction: Real-World Data. Voir source | 42585517 | 10.36660/abc.20260069 | Arquivos brasileiros de cardiologia | |
| Biomarker-guided pharmacotherapy in cardiovascular-kidney-metabolic syndrome: A three-dimensional framework for precision drug selection and monitoring. Voir source | 42492739 | 10.1016/j.pharmthera.2026.109089 | Pharmacology & therapeutics | |
| Bibliometric analysis of sacubitril/valsartan in the management of chronic kidney disease (2013-2025). Voir source | 41943607 | 10.1080/0886022X.2026.2644751 | Renal failure | |
| Spatially resolved label-free FTIR imaging reveals compartment-specific spectral signatures of cardiorenal crosstalk and their pharmacological modulation by Sacubitril/Valsartan. Voir source | 42456519 | 10.1016/j.saa.2026.128435 | Spectrochimica acta. Part A, Molecular and biomolecular spectroscopy | |
| A pharmacokinetic and pharmacodynamic drug interaction between rosuvastatin and valsartan in healthy subjects. Voir source | 25767372 | 10.2147/DDDT.S76942 | Drug design, development and therapy | |
| Effect of Amlodipine/Valsartan Versus Nebivolol/Valsartan Fixed Dose Combinations on Peripheral and Central Blood Pressure. Voir source | 30390203 | 10.1007/s40292-018-0286-8 | High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension | |
| Innovative valsartan-loaded self-nanoemulsifying drug delivery system combat liver inflammation and oxidative stress in streptozotocin-induced diabetic rats. Voir source | 42118427 | 10.1007/s11010-026-05534-w | Molecular and cellular biochemistry | |
| In symptomatic HF, sacubitril-valsartan vs. dapagliflozin and torsemide vs. furosemide did not differ for health status at 6 mo. Voir source | 42546309 | 10.7326/ANNALS-26-02647-JC | Annals of internal medicine | |
| Dose optimization of sacubitril/valsartan in Chinese chronic heart failure patients: integration of physiologically based pharmacokinetic modeling and real-world data. Voir source | 42558440 | 10.3389/fphar.2026.1875094 | Frontiers in pharmacology | |
| Additive beneficial effects of valsartan combined with rosuvastatin in the treatment of hypercholesterolemic hypertensive patients. Voir source | 26023311 | 10.4070/kcj.2015.45.3.225 | Korean circulation journal | |
| Effect of Amlodipine/Nebivolol combination therapy on central BP and PWV compared to Amlodipine/Valsartan combination therapy. Voir source | 35286492 | 10.1186/s43044-022-00254-0 | The Egyptian heart journal : (EHJ) : official bulletin of the Egyptian Society of Cardiology | |
| Effect of Fixed-dose Combination Amlodipine/Valsartan in Comparison to Two Drug Combination Nebivolol/Valsartan on 24-Hour Ambulatory Blood Pressure. Voir source | 36998137 | 10.2174/1573402119666230330082128 | Current hypertension reviews | |
| Pharmacokinetic Drug Interactions Between Amlodipine, Valsartan, and Rosuvastatin in Healthy Volunteers. Voir source | 31119689 | 10.1007/s12325-019-00976-9 | Advances in therapy |
Sources officielles
liens de rechercheDernière mise à jour des données : 2022-09-16
Ces sources sont proposées pour vérification. Les informations de la fiche doivent être confirmées dans les registres officiels ou les publications originales.