Back to resultsA Multicenter Trial to Investigate the Efficacy and Safety of Tolvaptan in Patients With Hyponatremia in SIADH
Primary Purpose
Syndrome of Inappropriate Antidiuretic Hormone Secretion
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Tolvaptan Oral Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Syndrome of Inappropriate Antidiuretic Hormone Secretion
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tolvaptan
Arm Description
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.
Outcomes
Primary Outcome Measures
Percentage of Subjects With Normalized Serum Sodium Concentration on the Day After Final IMP Administration
The percentage of subjects with normalized serum sodium concentration, defined as ≥135 mEq/L, on the day after final IMP administration will be calculated versus the number of subjects with serum sodium concentration of <135 mEq/L at baseline on Day 1 of the treatment period.
Secondary Outcome Measures
Change in Serum Sodium Concentration
The mean and standard error of measured values for serum sodium concentration on the day of fixing the maintenance dose and on the day after final IMP administration were calculated.
The day of fixing the maintenance dose: Day2, Day3, Day4, Day5, Day7, Day14, and Day21
Full Information
NCT ID
NCT03048747
First Posted
February 7, 2017
Last Updated
October 8, 2020
Sponsor
Otsuka Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03048747
Brief Title
A Multicenter Trial to Investigate the Efficacy and Safety of Tolvaptan in Patients With Hyponatremia in SIADH
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
March 2, 2017 (Actual)
Primary Completion Date
March 19, 2019 (Actual)
Study Completion Date
March 19, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Syndrome of Inappropriate Antidiuretic Hormone Secretion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tolvaptan
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tolvaptan Oral Tablet
Intervention Description
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 Measure Information:
Title
Percentage of Subjects With Normalized Serum Sodium Concentration on the Day After Final IMP Administration
Description
The percentage of subjects with normalized serum sodium concentration, defined as ≥135 mEq/L, on the day after final IMP administration will be calculated versus the number of subjects with serum sodium concentration of <135 mEq/L at baseline on Day 1 of the treatment period.
Time Frame
Baseline, Day2, Day3, Day4, Day5, Day7, Day14, Day21, Day after final study medication
Secondary Outcome Measure Information:
Title
Change in Serum Sodium Concentration
Description
The mean and standard error of measured values for serum sodium concentration on the day of fixing the maintenance dose and on the day after final IMP administration were calculated.
The day of fixing the maintenance dose: Day2, Day3, Day4, Day5, Day7, Day14, and Day21
Time Frame
Day2, Day3, Day4, Day5, Day7, Day14, Day21 and the day after final IMP administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Chubu Region
Country
Japan
City
Chugoku Region
Country
Japan
City
Kanto Region
Country
Japan
City
Kinki Region
Country
Japan
City
Kyushu Region
Country
Japan
City
Sikoku Region
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.
Supporting Materials: Study Protocol and Statistical Analysis Plan (SAP) Data will be available after marketing approval in global markets, or beginning 1-3 years following article Publication. There is no end date to the availability of the data.
Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.
IPD Sharing Time Frame
Data will be available aftermarketing approval in global markets, or beginning1-3 years following article Publication. There is no end date to the availability of the data.
IPD Sharing Access Criteria
Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and Ranalytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.
Learn more about this trial
A Multicenter Trial to Investigate the Efficacy and Safety of Tolvaptan in Patients With Hyponatremia in SIADH
We'll reach out to this number within 24 hrs