Hyponatremia
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CLINICAL_TRIALS research · 2024-11-19Clinical Trial Update: Hyponatremia Volume Status Analysis by Point-of-care Ultrasound
This clinical trial is evaluating volume status analysis in hyponatremia using point-of-care ultrasound and is currently active but not recr…
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CLINICAL_TRIALS trial_result · 2024-11-05Clinical Trial Update: Mortality and Neurologic Outcomes in Rapid vs. Slow Hyponatremia Correction
This completed clinical trial evaluated mortality and neurologic outcomes in rapid versus slow correction of hyponatremia to assess safety a…
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CLINICAL_TRIALS trial_result · 2024-07-23Clinical Trial Update: Hyponatremia Study (Delayed Hyponatremia After Pituitary Surgery) [NA]
This completed clinical trial evaluated delayed hyponatremia after pituitary surgery.
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CLINICAL_TRIALS research · 2024-07-12Clinical Trial Update: Saline Infusion Test in Hyponatremia
A clinical trial update notes a saline infusion test being studied for hyponatremia, with the study currently NOT_YET_RECRUITING.
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CLINICAL_TRIALS trial_result · 2024-07-03Clinical Trial Update: Comparison of Isotonic Versus Hypotonic Fluids in Neonates for Maintenance Fluid Therapy After Surgery [NA]
This completed clinical trial compared isotonic and hypotonic fluids for maintenance fluid therapy in neonates after surgery.
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CLINICAL_TRIALS research · 2024-05-21Clinical Trial Update: Establishment of an Algorithm for a Clinical Classfication of Hypoosmolar Hyponatremia
This clinical trial update describes the development of an algorithm to classify hypoosmolar hyponatremia.
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CLINICAL_TRIALS trial_result · 2024-05-20Clinical Trial Update: Urea for Chronic Hyponatremia [Phase 2]
Phase 2 trial evaluating urea for chronic hyponatremia was terminated. Results were posted on 2024-05-20.
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CLINICAL_TRIALS trial_result · 2024-05-09Clinical Trial Update: Colloid Osmotic Pressure and Osmolality in Hyponatremia
The clinical trial evaluating colloid osmotic pressure and osmolality in hyponatremia has been terminated.
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FDA approval · 2023-06-21FDA Approved: TOLVAPTAN — Original Application (Novadoz Pharmaceuticals LLC)
FDA approves an original generic application for tolvaptan from Novadoz Pharmaceuticals LLC.
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FDA approval · 2022-11-08FDA Approved: TOLVAPTAN — Supplemental Application (Apotex Corp.)
FDA approved a supplemental application for tolvaptan by Apotex Corp., indicating a regulatory update to the generic product's approval (suc…
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FDA approval · 2022-09-06FDA Approved: TOLVAPTAN — Original Application (Ascend Laboratories, LLC)
FDA approved a generic version of tolvaptan under an Original Application (ANDA) filed by Ascend Laboratories, LLC.
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FDA approval · 2022-09-06FDA Approved: TOLVAPTAN — Original Application (Camber Pharmaceuticals, Inc.)
FDA approved Camber Pharmaceuticals' tolvaptan as a generic drug through an Original Application (ANDA). The product is indicated for the tr…
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FDA approval · 2022-02-15FDA Approved: TOLVAPTAN — Original Application (Endo USA, Inc.)
FDA approved Endo USA, Inc.'s original application for tolvaptan, a vasopressin V2 receptor antagonist, for the treatment of hyponatremia. T…
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CLINICAL_TRIALS trial_result · 2021-12-13Clinical Trial Update: Effects of the SGLT2-inhibitor Empagliflozin on Patients With Chronic SIADH - the SANDx Study [Phase 2, Phase 3]
Phase 2/3 trial evaluating empagliflozin for SIADH-related hyponatremia has completed.
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CLINICAL_TRIALS trial_result · 2021-09-05Clinical Trial Update: Cicletanine in Hypertension With Diabetes: Added Magnesium Preserves Potassium and Sodium [Phase 1, Phase 2]
A clinical trial update on cicletanine in hypertension with diabetes discusses added magnesium to preserve potassium and sodium, spanning Ph…
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FDA approval · 2021-07-16FDA Approved: TOLVAPTAN — Original Application (Camber Pharmaceuticals, Inc.)
FDA approves Camber Pharmaceuticals' tolvaptan via an original (ANDA) application, indicating a generic tolvaptan product is approved.
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FDA approval · 2021-04-22FDA Approved: SAMSCA — Supplemental Application (Otsuka America Pharmaceutical, Inc.)
FDA approved a supplemental application for Samsca (tolvaptan) from Otsuka America Pharmaceutical, Inc.
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CLINICAL_TRIALS trial_result · 2020-07-27Clinical Trial Update: Tolvaptan for Advanced or Refractory Heart Failure [Phase 4]
A Phase 4 clinical trial of tolvaptan for advanced or refractory heart failure has been terminated.
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FDA approval · 2020-05-19FDA Approved: TOLVAPTAN — Original Application (Ascend Laboratories, LLC)
FDA approved Ascend Laboratories LLC's original ANDA for tolvaptan, a vasopressin V2 receptor antagonist, as a generic option for treating h…
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FDA approval · 2020-05-19FDA Approved: TOLVAPTAN — Original Application (Apotex Corp.)
FDA approved Apotex Corp.'s Abbreviated New Drug Application for tolvaptan, creating a generic version of the vasopressin V2 receptor antago…
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CLINICAL_TRIALS trial_result · 2020-04-17Clinical Trial Update: An Extension Follow-up Trial to Evaluate the Long-term Safety of Children and Adolescent Participants With Euvolemic or Hypervolemic Hyponatremia [Phase 3]
Phase 3 extension trial evaluating long-term safety in children and adolescents with euvolemic or hypervolemic hyponatremia; the study statu…
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CLINICAL_TRIALS trial_result · 2020-04-09Clinical Trial Update: Efficacy and Safety of Rapid Intermittent Compared With Slow Continuous Correction in Severe Hyponatremia Patients [Phase 4]
Phase 4 trial update evaluating efficacy and safety of rapid intermittent correction versus slow continuous correction in symptomatic hypona…
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CLINICAL_TRIALS trial_result · 2020-04-08Clinical Trial Update: Early Sodium Intake in Preterm Newborns [Phase 4]
Phase 4 clinical trial update on early sodium intake in preterm newborns completed with posted results.
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CLINICAL_TRIALS trial_result · 2019-08-22Clinical Trial Update: Intravenous Fluids in Hospitalised Children [Phase 4]
A Phase 4 trial update on intravenous fluids in hospitalized children completed, investigating safety or efficacy related to electrolyte imb…
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CLINICAL_TRIALS trial_result · 2019-02-15Clinical Trial Update: Fluid Tonicity and Hyponatraemia Post Surgery
A completed clinical trial evaluating the effect of fluid tonicity on hyponatremia after surgery. The study is sponsored by National Univers…