Effect of Samsca on Control of Hyponatremia and Extracellular Fluid in Cirrhotic Patients With Ascites (ECF)
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ClinicalTrials.gov Identifier: NCT01552590 |
Recruitment Status
: Unknown
Verified January 2013 by Korea Otsuka Pharmaceutical Co., Ltd..
Recruitment status was: Recruiting
First Posted
: March 13, 2012
Last Update Posted
: January 4, 2013
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hyponatremia and Extracellular Fluid in Cirrhotic | Drug: Tolvaptan Drug: Placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 74 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Effect of Samsca on Control of Hyponatremia and Extracellular Fluid in Cirrhotic Patients With Ascites |
Study Start Date : | April 2012 |
Estimated Primary Completion Date : | January 2013 |
Estimated Study Completion Date : | January 2013 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Tolvaptan, Tablet, QD, 2 weeks | Drug: Tolvaptan |
Placebo Comparator: Placebo, Tablet, QD, 2 weeks | Drug: Placebo |
- Serum Na [ Time Frame: 2 weeks (Baseline, Day 14) ]
- BCM (body composition monitoring) [ Time Frame: 7 days ]
- body weight [ Time Frame: 7 days ]
- A composite endpoint of ascites worsening [ Time Frame: in case ]
- Serum Na normalization rate [ Time Frame: 14 days ]
- Biochemistry [ Time Frame: 7 days ]Total protein, Albumin, ALP, ALT, AST, r-GT, BUN, Creatinine, Glucose, Cl, K, Na, Ca, Total bilirubin, Uric acid), Hematology (WBC count, Hemoglobin, Hematocrit, Platelets, Serum osm, NT pro-BNP
- ECG [ Time Frame: 7 days ]
- Adverse event [ Time Frame: Daily ]
- Physical examination [ Time Frame: 7 days ]HEENT, Thorax, Abdomen, Urogenital, Extremities, Neurological, Skin and Mucosae
- Vital signs [ Time Frame: Daily ]
- Blood coagulation [ Time Frame: 7 days ]PT, INR
- Urinalysis [ Time Frame: 7 days ]Protein, pH, Glucose, Blood, Bilirubin, Urobilinogen, Random urine Na/K, Urine osm

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Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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): NCT01552590
Contact: YoungJin Choi | +82232879255 | youngjin@otsuka.co.kr |
Korea, Republic of | |
Hallym Univ. Chuncheon Sacred Heart Hospital | Recruiting |
Bucheon, Korea, Republic of | |
Contact: KiTae Suk, Assistant professor | |
Principal Investigator: KiTae Suk, Assistant professor | |
Soonchunhyang Univ. Bucheon Hospital | Recruiting |
Bucheon, Korea, Republic of | |
Contact: YoungSeok Kim, Associate professor | |
Principal Investigator: YoungSeok Kim, Associate professor | |
Wonju Christian Hospital | Recruiting |
Wonju, Korea, Republic of | |
Contact: SoonKoo Baik, Professor | |
Principal Investigator: SoonKoo Baik, Professor |
Responsible Party: | Korea Otsuka Pharmaceutical Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT01552590 History of Changes |
Other Study ID Numbers: |
156-KOB-1101i |
First Posted: | March 13, 2012 Key Record Dates |
Last Update Posted: | January 4, 2013 |
Last Verified: | January 2013 |
Additional relevant MeSH terms:
Ascites Hyponatremia Pathologic Processes Water-Electrolyte Imbalance Metabolic Diseases |
Tolvaptan Antidiuretic Hormone Receptor Antagonists Molecular Mechanisms of Pharmacological Action Natriuretic Agents Physiological Effects of Drugs |