ClinicalTrials.gov
ClinicalTrials.gov Menu

A Multicenter Trial to Investigate the Efficacy and Safety of Tolvaptan in Patients With Hyponatremia in SIADH

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03048747
Recruitment Status : Recruiting
First Posted : February 9, 2017
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Brief Summary:
The objective of this study is to investigate the efficacy and safety of tolvaptan based on the change in serum sodium concentration following administration of tolvaptan oral tablets at 7.5 to 60 mg/day for up to 30 days in patients with hyponatremia in the SIADH.

Condition or disease Intervention/treatment Phase
Syndrome of Inappropriate Antidiuretic Hormone Secretion Drug: Tolvaptan Oral Tablet Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Uncontrolled, Open-label, Dose-titration Trial to Investigate the Efficacy and Safety of Tolvaptan Tablets in Patients With Hyponatremia in Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)
Actual Study Start Date : January 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Tolvaptan

Arm Intervention/treatment
Experimental: Tolvaptan
Tolvaptan tablets at 7.5, 15, 30 (one tablet each), or 60 mg (two 30 mg tablets) will be orally administered once daily after breakfast for up to 30 days.
Drug: Tolvaptan Oral Tablet
Tolvaptan tablets at 7.5, 15, 30 (one tablet each), or 60 mg (two 30 mg tablets) will be orally administered once daily after breakfast for up to 30 days.




Primary Outcome Measures :
  1. Percentage of subjects with normalized serum sodium concentration [ Time Frame: Day 1, Day2, Day 3, Day4, Day 5, Day 7, Day 14, Day 21, Day after final IMP administration, and 7 days after final IMP administration ]
    Percentage of subjects with normalized serum sodium concentration (≥ 135 mEq/L) on the day after final IMP administration


Secondary Outcome Measures :
  1. Change in serum sodium concentration [ Time Frame: Day 1, Day2, Day 3, Day4, Day 5, Day 7, Day 14, Day 21, Day after final IMP administration, and 7 days after final IMP administration ]
    Change in serum sodium concentration

  2. Time course of serum sodium concentrations [ Time Frame: Screening, Day -1, Day 1, Day2, Day 3, Day4, Day 5, Day 7, Day 14, Day 21, Day after final IMP administration, and 7 days after final IMP administration ]
    Time course of serum sodium concentrations

  3. Changes in clinical symptoms associated with hyponatremia [ Time Frame: Screening, Day -1, Day 1, Day 3, Day 5, Day 7, Day 14, Day 21, Day after final IMP administration, and 7 days after final IMP administration ]
    Changes in clinical symptoms associated with hyponatremia



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with a definite diagnosis of SIADH in reference to "Diagnostic and Treatment Manual of the Hypersecretion of Vasopressin (SIADH), Revised in 2011"
  • Subjects who have been on fluid restriction for at least 7 consecutive days at the time of informed consent and who are showing no improvement of hyponatremia at the time of the screening examination

Exclusion Criteria:

  • Subjects who have transient hyponatremia induced by drug administration
  • Subjects who are unable to sense thirst or who have difficulty with fluid intake
  • Subjects with urinary tract obstruction
  • Subjects who have participated in any other clinical trial within 30 days prior to informed consent
  • Subjects with serum sodium concentration of <120 mEq/L associated with neurologic impairment, including apathy, confusion, or seizures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03048747


Contacts
Contact: Drug Information Center +81-3-6361-7314

Locations
Japan
Recruiting
Chubu Region, Japan
Recruiting
Chugoku Region, Japan
Recruiting
Kanto Region, Japan
Recruiting
Kinki Region, Japan
Recruiting
Kyushu Region, Japan
Recruiting
Sikoku Region, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03048747     History of Changes
Other Study ID Numbers: 156-14-003
JapicCTI-173512 ( Other Identifier: Japic )
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Insipidus
Syndrome
Hyponatremia
Inappropriate ADH Syndrome
Disease
Pathologic Processes
Water-Electrolyte Imbalance
Metabolic Diseases
Kidney Diseases
Urologic Diseases
Pituitary Diseases
Endocrine System Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tolvaptan
Antidiuretic Hormone Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs