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96
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ShareScore release 0.8.0
Dataset results
96 results for “Tolvaptan”
Multicenter, Randomized, Double-Blind, Placebo Controlled, Efficacy Study on the Effects of Tolvaptan on Left Ventricular Dilatation in Congestive Heart Failure Patients
ClinicalTrials.gov study NCT00043758. IPD Sharing: Not stated. Countries: 2. Publications: 1.
"SALT-2 Trial" Study of Ascending Levels of Tolvaptan in Hyponatremia
ClinicalTrials.gov study NCT00201994. IPD Sharing: Not stated. Countries: 1. Publications: 3.
Tolvaptan-Octreotide LAR Combination in ADPKD
ClinicalTrials.gov study NCT03541447. IPD Sharing: NO. Countries: 1. Publications: 2.
Effect of the Aquaretic Tolvaptan on Nitric Oxide System
ClinicalTrials.gov study NCT02527863. IPD Sharing: Not stated. Countries: 1. Publications: 2.
Phase III Study of Tolvaptan Tablet to Treat Cirrhosis Ascites
ClinicalTrials.gov study NCT01349348. IPD Sharing: Not stated. Countries: 1. Publications: 2.
The German ADPKD Tolvaptan Treatment Registry
ClinicalTrials.gov study NCT02497521. IPD Sharing: Not stated. Countries: 1. Publications: 5.
Heart Pressure Assessment Study With Tolvaptan to Treat Congestive Heart Failure
ClinicalTrials.gov study NCT00132886. IPD Sharing: Not stated. Countries: 2. Publications: 2.
Dose Exploring and Setting Study for Tolvaptan to Treat Hepatic Cirrhosis With Ascites
ClinicalTrials.gov study NCT01349335. IPD Sharing: Not stated. Countries: 1. Publications: 1.
"SALT Trial" Study of Ascending Levels of Tolvaptan in Hyponatremia
ClinicalTrials.gov study NCT00072683. IPD Sharing: Not stated. Countries: 1. Publications: 3.
Efficacy of Tolvaptan on ADPKD Patients
ClinicalTrials.gov study NCT02729662. IPD Sharing: NO. Countries: 1. Publications: 11.
Post-Authorisation Safety Study of Samsca (Tolvaptan) Used in Routine Medical Practice
ClinicalTrials.gov study NCT01228682. IPD Sharing: Not stated. Countries: 7. Publications: 1.
EVEREST: Efficacy of Vasopressin Antagonism in hEart failuRE: Outcome Study With Tolvaptan
ClinicalTrials.gov study NCT00071331. IPD Sharing: Not stated. Countries: 18. Publications: 12.
Role of Midodrine and Tolvaptan in Patients With Cirrhosis With Refractory or Recurrent Ascites
ClinicalTrials.gov study NCT02173288. IPD Sharing: Not stated. Countries: 1. Publications: 1.
International, Multicenter, Study of One-year, Open-label, Titrated Oral Tolvaptan Tablet Administration in Patients With Chronic Hyponatremia
ClinicalTrials.gov study NCT02449044. IPD Sharing: Not stated. Countries: 0. Publications: 1.
Efficacy and Safety of Tolvaptan in Cirrhotic Patients With Hyponatremia
ClinicalTrials.gov study NCT01850940. IPD Sharing: Not stated. Countries: 1. Publications: 0.
Effect of the Aquaretic Tolvaptan on Nitric Oxide System. A Dose-response Study (DOVA)
ClinicalTrials.gov study NCT02078973. IPD Sharing: Not stated. Countries: 1. Publications: 1.
Multiple-dose Pharmacokinetics Study of Tolvaptan Tablets in Chinese Patients With Hepatocirrhosis
ClinicalTrials.gov study NCT01359462. IPD Sharing: Not stated. Countries: 1. Publications: 1.
Tolvaptan for Patients With Acute Neurological Injuries
ClinicalTrials.gov study NCT02545114. IPD Sharing: Not stated. Countries: 1. Publications: 11.
A Phase 2 Efficacy and Safety Study of the Tolvaptan Tablets in Patients With Non-hypovolemic Non-acute Hyponatremia
ClinicalTrials.gov study NCT00664014. IPD Sharing: Not stated. Countries: 1. Publications: 2.
Data from: Candidate risk factors and mechanisms for tolvaptan-induced liver injury are identified using a collaborative cross approach
Clinical trials of tolvaptan showed it to be a promising candidate for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD) but also revealed potential for idiosyncratic drug-induced liver injury (DILI) in this patient population. To identify risk factors and mechanisms underlying tolvaptan DILI, 8 mice in each of 45 strains of the genetically diverse Collaborative Cross (CC) mouse population were treated with a single oral dose of either tolvaptan or vehicle. Significant elevations in plasma alanine aminotransferase (ALT) were observed in tolvaptan-treated animals in 3 of the 45 strains. Genetic mapping coupled with transcriptomic analysis in the liver was used to identify several candidate susceptibility genes including epoxide hydrolase 2, interferon regulatory factor 3, and mitochondrial fission factor. Gene pathway analysis revealed that oxidative stress and immune response pathways were activated in response to tolvaptan treatment across all strains, but genes involved in regulation of bile acid homeostasis were most associated with tolvaptan-induced elevations in ALT. Secretory leukocyte peptidase inhibitor (Slpi) mRNA was also induced in the susceptible strains and was associated with increased plasma levels of Slpi protein, suggesting a potential serum marker for DILI susceptibility. In summary, tolvaptan induced signs of oxidative stress, mitochondrial dysfunction, and innate immune response in all strains, but variation in bile acid homeostasis was most associated with susceptibility to the liver response. This CC study has indicated potential mechanisms underlying tolvaptan DILI and biomarkers of susceptibility that may be useful in managing the risk of DILI in ADPKD patients.
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