Effect of Samsca on Control of Hyponatremia and Extracell... | NCT01552590

Studies
Effect of Samsca on Control of Hyponatremia and Extracellular Fluid in Cirrhotic Patients With Ascites

NCT01552590

Sponsor

Korea Otsuka Pharmaceutical Co., Ltd.

Status

Terminated

Last Update Posted

Mar 4, 2022Actual

Enrollment

74Actual

Phase

Phase 4

Conditions

Hyponatremia and Extracellular Fluid in Cirrhotic

Interventions

Tolvaptan
Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Apr 2012Actual

Completion Date

Apr 2012Actual

First Submitted Date

Feb 21, 2012

First Submission Date that Met QC Criteria

Mar 9, 2012

First Posted Date

Mar 13, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 17, 2022

Last Update Posted Date

Mar 4, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

74Actual

Label	Type	Description	Intervention Names
Tolvaptan	Active Comparator	Tablet, QD, 2 weeks	Drug: Tolvaptan
Placebo	Placebo Comparator	Tablet, QD, 2 weeks	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Tolvaptan	Drug		Tolvaptan
Placebo

Measure	Description	Time Frame
Serum Na		2 weeks (Baseline, Day 14)

Measure	Description	Time Frame
BCM (body composition monitoring)		7 days
body weight		7 days
A composite endpoint of ascites worsening

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects aged ≥ 20 years
Subjects who have been diagnosed with hyponatremia [serum sodium < 125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction]
Subjects who have been diagnosed with an ascites on the abdominal ultrasound.
Subjects who have diagnosed with cirrhosis.
Subject or their legally acceptable representatives are able to provide informed consent/assent.

Exclusion Criteria:

Subject who has ascites by other causes (Tbc, CHF, malignancy, or renal disease) acute severe hyponatemia : Serum Na level < 120 mmol/L and Doubt of symptom caused by hyponatremia and the case which should raise serum Na level urgently based on the investigator's judgment international normalized ratio (INR) >3.0 serum sodium ≥135 mmol/L serum potassium > 5.5 mmol/L Creatinine ≥ 2.0 mg/dL Hepatorenal syndrome defined as 'New International Ascites Club's diagnostic criteria' systolic arterial pressure of < 80 mmHg recent myocardial infarction (< 6 month) spontaneous bacterial peritonitis gastrointestinal bleed ( ≤7 days from randomization) ongoing hepatic encephalopathy of > grade1 known hepatocellular carcinoma intractable ascites
Subject who requiring urgent intervention to raise serum sodium acutely
Subject who are unable to sense or to respond appropriately to thirst
Subject with hypovolemic hyponatremia
Subject who should take strong CYP3A inhibitors (clarithromycin, ketoconazole, itraconazole, ritonavir, indinavir, nelfinavir, saquinavir, nefazodone, and telithromycin)
Subject who are anuric as no benefit is expected
Subject who has genetic defects such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
Subject who has fluid depletion
Female subjects who are pregnant or lactating
Subject judged by the investigator to be inappropriate for inclusion in the trial for any other reason

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Hallym Univ. Chuncheon Sacred Heart Hospital		Bucheon-si			South Korea
Soonchunhyang Univ. Bucheon Hospital

ID	Term
D014883	Water-Electrolyte Imbalance
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds