Syndrome of Inappropriate Antidiuretic Hormone Secretion
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CLINICAL_TRIALS withdrawal · 2015-09-15Clinical Trial Update: Urinary Aquaporine 2 in Patients With Syndrome of Inappropriate ADH-secretion Caused by Treatment With Antiepileptic Medicine [Phase 4]
A Phase 4 clinical trial investigating urinary aquaporin-2 in patients with syndrome of inappropriate antidiuretic hormone secretion caused …
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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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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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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…
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CLINICAL_TRIALS trial_result · 2012-05-03Clinical Trial Update: "SALT-2 Trial" Study of Ascending Levels of Tolvaptan in Hyponatremia [Phase 3]
Phase 3 SALT-2 trial evaluating ascending doses of tolvaptan for hyponatremia has completed.
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CLINICAL_TRIALS trial_result · 2012-01-12Clinical Trial Update: The Clinical and Laboratory Characteristics of Recurrent Drug- Related Hyponatremia
This clinical trial update describes the clinical and laboratory characteristics of recurrent drug-related hyponatremia, including hyponatre…
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FDA approval · 2009-05-19FDA Approved: SAMSCA — Original Application (Otsuka America Pharmaceutical, Inc.)
FDA approved Samsca (tolvaptan) from Otsuka America for the treatment of clinically significant hyponatremia in adults, including hyponatrem…
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CLINICAL_TRIALS trial_result · 2009-01-21Clinical Trial Update: Safety and Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion [Phase 3]
Phase 3 clinical trial evaluating the safety and efficacy of SR121463B in patients with Syndrome of inappropriate antidiuretic hormone secre…
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CLINICAL_TRIALS trial_result · 2008-12-10Clinical Trial Update: Efficacy and Safety of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion [Phase 3]
Phase 3 trial evaluating the efficacy and safety of SR121463B in patients with syndrome of inappropriate antidiuretic hormone secretion (SIA…
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CLINICAL_TRIALS trial_result · 2008-06-17Clinical Trial Update: Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion [Phase 2]
Phase 2 trial evaluating the efficacy of SR121463B in Syndrome of inappropriate antidiuretic hormone secretion and hyponatremia has complete…
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CLINICAL_TRIALS trial_result · 2007-01-26Clinical Trial Update: "SALT Trial" Study of Ascending Levels of Tolvaptan in Hyponatremia [Phase 3]
The SALT trial, a Phase 3 study evaluating escalating doses of tolvaptan for hyponatremia, has completed.