Hyponatremia
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CLINICAL_TRIALS trial_result · 2016-01-21Clinical Trial Update: International, Multicenter, Study of One-year, Open-label, Titrated Oral Tolvaptan Tablet Administration in Patients With Chronic Hyponatremia [Phase 3]
An international, multicenter phase 3 study evaluating one-year, open-label, titrated oral tolvaptan in patients with chronic hyponatremia; …
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CLINICAL_TRIALS research · 2015-10-28Clinical Trial Update: The Effect of Fluid Restriction in Congestive Heart Failure Complicated With Hyponatremia [NA]
This clinical trial investigates fluid restriction in patients with heart failure complicated by hyponatremia. The current study status is u…
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CLINICAL_TRIALS trial_result · 2015-10-14Clinical Trial Update: Hyponatremia and Myometrium Contractility. An Invitro Study
An in vitro study investigating hyponatremia and myometrium contractility has been terminated.
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CLINICAL_TRIALS trial_result · 2015-09-22Clinical Trial Update: Pico-Salax Colonic Preparation Study: Quantifying Electrolyte and Volume Status Changes [Phase 4]
Phase 4 study updating electrolyte and volume status changes associated with Pico-Salax colonic preparation.
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CLINICAL_TRIALS trial_result · 2015-07-28Clinical Trial Update: Efficacy and Safety of Tolvaptan in Cirrhotic Patients With Hyponatremia
This clinical trial update reports on the efficacy and safety of tolvaptan in cirrhotic patients with hyponatremia, with the trial status co…
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CLINICAL_TRIALS withdrawal · 2015-07-23Clinical Trial Update: Frequency and Origin of Dysnatremias in the Emergency Department
A clinical trial (NCT01326429) on the frequency and origin of dysnatremias in the emergency department has been withdrawn. Sponsors Insel Gr…
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CLINICAL_TRIALS trial_result · 2015-05-05Clinical Trial Update: Influence of Triathlon on the Electrolyte Balance
A completed clinical trial from the University Hospital of Cologne evaluated the impact of triathlon on electrolyte balance in individuals w…
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CLINICAL_TRIALS research · 2015-04-29Clinical Trial Update: Relationship Between Heat Wave and Hyponatremia
This update summarizes findings from a completed clinical trial investigating whether heat waves are associated with an increased risk of hy…
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CLINICAL_TRIALS withdrawal · 2015-03-06Clinical Trial Update: Safety and Efficacy of Conivaptan for the Correction of Hyponatremia in Neurological Patients [Phase 3]
Phase 3 trial evaluating conivaptan for correcting hyponatremia in neurological patients has been withdrawn.
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CLINICAL_TRIALS trial_result · 2014-11-03Clinical Trial Update: Bioimpedance Spectroscopy for the Differential Diagnosis of Hyponatremia
This clinical trial completed an evaluation of bioimpedance spectroscopy as a tool for differentiating the causes of hyponatremia.
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CLINICAL_TRIALS trial_result · 2014-10-17Clinical Trial Update: Effects of Tolvaptan vs Fluid Restriction in Hospitalized Subjects With Dilutional Hyponatremia [Phase 3]
Phase 3 trial evaluating tolvaptan versus fluid restriction in hospitalized patients with dilutional hyponatremia was terminated; results we…
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CLINICAL_TRIALS trial_result · 2014-06-10Clinical Trial Update: Hypertonic Saline Solution in Heart Failure [Phase 2]
Phase 2 trial evaluating hypertonic saline solution in heart failure has completed, with results awaiting final analysis.
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CLINICAL_TRIALS trial_result · 2014-05-02Clinical Trial Update: An Open-Label Study of YM087 (Conivaptan) in Patients With Euvolemic or Hypervolemic Hyponatremia [Phase 3]
Phase 3 open-label study of conivaptan (YM087) in patients with euvolemic or hypervolemic hyponatremia has completed.
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CLINICAL_TRIALS trial_result · 2014-05-02Clinical Trial Update: Study to Compare Conivaptan in Subjects With Mild & Moderate Liver Impairment Versus Subjects With Normal Liver Function [Phase 1]
Phase 1 trial update comparing conivaptan pharmacokinetics in subjects with mild to moderate liver impairment versus those with normal liver…
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CLINICAL_TRIALS trial_result · 2014-05-02Clinical Trial Update: Study to Compare Conivaptan Pharmacokinetics in Subjects With Mild & Moderate Kidney Function Impairment to Subjects With Normal Kidney Function [Phase 1]
This completed Phase 1 study assesses how kidney function affects the pharmacokinetics of conivaptan, comparing mild/moderate impairment to …
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CLINICAL_TRIALS trial_result · 2014-05-02Clinical Trial Update: Study of IV YM087 to Assess Efficacy and Safety in Patients With Euvolemic or Hypervolemic Hyponatremia [Phase 3]
This Phase 3 clinical trial update indicates that the intravenous agent YM087, sponsored by Cumberland Pharmaceuticals, completed a study as…
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CLINICAL_TRIALS trial_result · 2014-05-02Clinical Trial Update: Study of Efficacy & Safety of Oral YM087 in Subjects With Euvolemic or Hypervolemic Hyponatremia [Phase 3]
Phase 3 study evaluating the efficacy and safety of oral YM087 in adults with euvolemic or hypervolemic hyponatremia has completed.
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FDA approval · 2014-02-28FDA Approved: SAMSCA — Supplemental Application (Otsuka America Pharmaceutical, Inc.)
FDA approved a supplemental application for SAMSCA (tolvaptan) filed by Otsuka America Pharmaceutical, Inc. The action updates the product l…
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CLINICAL_TRIALS trial_result · 2014-02-07Clinical Trial Update: Effect of Tolvaptan on Cognitive Function in Cirrhosis [Phase 3]
A Phase 3 trial evaluating tolvaptan for cognitive function in patients with cirrhosis and hepatic encephalopathy, including cases associate…
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FDA label_change · 2013-09-27FDA Approved: SAMSCA — Supplemental Application (Otsuka America Pharmaceutical, Inc.)
FDA supplemental application for SAMSCA (tolvaptan) submitted by Otsuka America Pharmaceutical, Inc., for a labeling change. The filing indi…
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CLINICAL_TRIALS trial_result · 2013-08-26Clinical Trial Update: 0.9% NaCl/Dextrose 5% vs 0.45% NaCl/Dextrose 5% as Maintenance Intravenous Fluids in Hospitalized Children [Phase 3]
Phase 3 trial comparing maintenance IV fluids—0.9% saline with 5% dextrose vs 0.45% saline with 5% dextrose—in hospitalized children with hy…
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CLINICAL_TRIALS trial_result · 2013-06-12Clinical Trial Update: Postoperative Hyponatremia - Are There Gender Differences? [NA]
A clinical trial update examining whether postoperative hyponatremia differs between genders.
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CLINICAL_TRIALS trial_result · 2013-06-05Clinical Trial Update: Incidence of Hyponatremia in PEG-SD Compared to PEG-ELS [NA]
A completed clinical trial compares the incidence of hyponatremia between PEG-SD and PEG-ELS preparations (NCT01299779), as reported by Thom…
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FDA label_change · 2013-05-02FDA Approved: SAMSCA — Supplemental Application (Otsuka America Pharmaceutical, Inc.)
FDA supplemental application for SAMSCA (tolvaptan) from Otsuka America Pharmaceutical seeks labeling changes.
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CLINICAL_TRIALS safety_alert · 2013-05-01Clinical Trial Update: Post-Authorisation Safety Study of Samsca (Tolvaptan) Used in Routine Medical Practice
Post-authorization safety study evaluating the real-world safety of tolvaptan (Samsca) in patients with hyponatremia, including SIADH-relate…