Effects of Tolvaptan vs Fluid Restriction in Hospitalized Subjects With Dilutional Hyponatremia
NCT ID: NCT01227512
Last Updated: 2014-10-30
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
124 participants
INTERVENTIONAL
2010-10-31
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Tolvaptan 15-60mg
Oral tablet without fluid restriction. After the initial dose, daily dose may be titrated based on response.
tolvaptan
15 mg titrated to 30 mg then 60 mg once daily as oral tablet for up to 7 days based on response.
Fluid Restriction
Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may titrated based response.
Fluid Restriction
Placebo tablet once daily with prescribed daily fluid intake of 1500 mL, then intensifying to 2 lower volumes of fluid intake for up to 7 days based on response.
Since all particpants were blinded to treatment, titration to stricter fluid restriction followed the same algorithm as tolvaptan, increasing both the level of fluid restriction and increasing the placebo "dose"
Interventions
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tolvaptan
15 mg titrated to 30 mg then 60 mg once daily as oral tablet for up to 7 days based on response.
Fluid Restriction
Placebo tablet once daily with prescribed daily fluid intake of 1500 mL, then intensifying to 2 lower volumes of fluid intake for up to 7 days based on response.
Since all particpants were blinded to treatment, titration to stricter fluid restriction followed the same algorithm as tolvaptan, increasing both the level of fluid restriction and increasing the placebo "dose"
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinically significant symptoms of hyponatremia, defined as a CGI-S score between 3-6, inclusive
* Female subjects of child bearing potential who agree to remain abstinent or to practice double-barrier forms of birth control from screening through 30 days following first dose on IMP
Exclusion Criteria
* Hyponatremia in hypovolemic states, defined as the presence of clinical and historical evidence of extracellular fluid volume depletion, including but not limited to skin turgor, orthostatic changes in blood pressure or heart rate, dry mucous membranes, or a response to IV saline challenge
* Subjects who are likely to require prolonged hospitalization for reasons other than hyponatremia, eg. new femoral fracture, surgeries requiring extended recovery
* Recent prior treatment for hyponatremia: hypertonic saline (including normal saline challenge) (within 8 hours of baseline) or urea, lithium, demeclocycline, conivaptan or tolvaptan (within 4 days of baseline). Includes any treatment, other than fluid restriction for the purpose of increasing serum sodium.
* Hyponatremia symptoms of a severity (eg, CGI = 7) such that they require immediate intervention with hypertonic saline; or are expected to require such therapy within 48 hours
* Causes of neurological symptoms which are attributable to psychological (psychosis), structural (dementia of the Alzheimer's type, stroke, transient ischemic attack, multi-infarct dementia) or other metabolic causes (eg. hyper- or hypo-: oxemia, glycemia, calcemia, ammonemia, etc)
* Acute and transient hyponatremia associated with head trauma or severe neurological injury (eg. stroke, subdural hematoma)or the use of recreational drugs.
* History of hyponatremia known to be due to severe, untreated hypothyroidism/adrenal insufficiency
* Subjects with psychogenic polydipsia
* Systolic arterial blood pressure \< 90 mmHg at screening
* History of hypersensitivity and/or idiosyncratic reaction to benzazepine or benzazepine derivatives (such as benazepril), or tolvaptan
* History of drug or medication abuse within the 3 months prior to screening, or current alcohol abuse
* Uncontrolled diabetes mellitus defined as glucose \> 300 mg/dL \[16.7 mmol/L\]
* Current urinary tract obstruction (eg, obstructive benign prostatic hypertrophy)
* Current condition of anuria
* Serum creatinine \> 3.5 mg/dL at screening
* Terminally ill or moribund condition with little chance of short-term (eg, 30 day) survival
* Subjects whose hyponatremia is the result of any medication that can safely be withdrawn (examples of drugs often not withdrawn include: anticonvulsants \[eg, carbamazepine\] and antipsychotics \[eg, haloperidol\])
* Patients receiving DDAVP within 2 days of screening
* Patients with history of active variceal bleeding within the past 30 days, without prior approval from sponsor medical monitor
* Participation in another investigational drug trial within the past 30 days
18 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ann Dandurand, MD
Role: STUDY_DIRECTOR
Otsuka Pharmaceutical Development & Commercialization, Inc.
Locations
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Otsuka Investigational Site
Birmingham, Alabama, United States
Otsuka Investigational Site
Birmingham, Alabama, United States
Otsuka Investigational Site
Mobile, Alabama, United States
Otsuka Investigational Site
Azusa, California, United States
Otsuka Investigational Site
Banning, California, United States
Otsuka Investigational Site
Culver City, California, United States
Otsuka Investigational Site
Fountain Valley, California, United States
Otsuka Investigational Site
Los Angeles, California, United States
Otsuka Investigational Site
Los Angeles, California, United States
Otsuka Investigational Site
Northridge, California, United States
Otuska Investigational Site
Orange, California, United States
Otsuka Investigational Site
Yorba Linda, California, United States
Otsuka Investigational Site
Denver, Colorado, United States
Otsuka Investigational Site
Washington D.C., District of Columbia, United States
Otsuka Investigational Site
Jacksonville, Florida, United States
Otsuka Investigational Site
Jacksonville, Florida, United States
Otsuka Investigational Site
Jacksonville, Florida, United States
Otsuka Investigational Site
Orlando, Florida, United States
Otsuka Investigational Site
Port Charlotte, Florida, United States
Otsuka Investigational Site
Savannah, Georgia, United States
Otsuka Investigational Site
Elizabethtown, Kentucky, United States
Otsuka Investigational Site
Baltimore, Maryland, United States
Otsuka Investigational Site
Springfield, Massachusetts, United States
Otsuka Investigational Site
Saginaw, Michigan, United States
Otsuka Investigational Site
Southfield, Michigan, United States
Otsuka Investigational Site
Minneapolis, Minnesota, United States
Otsuka Investigational Site
Rochester, Minnesota, United States
Otsuka Investigational Site
Jackson, Mississippi, United States
Otsuka Investigational Site
St Louis, Missouri, United States
Otsuka Investigational Site
Grand Island, Nebraska, United States
Otsuka Investigational Site
Omaha, Nebraska, United States
Otsuka Investigational Site
Haddon Heights, New Jersey, United States
Otsuka Investigational Site
Newark, New Jersey, United States
Otsuka Investigational Site
Buffalo, New York, United States
Otsuka Investigational Site
Buffalo, New York, United States
Otsuka Investigational Site
Jamaica, New York, United States
Otsuka Investigational Site
New York, New York, United States
Otsuka Investigational Site
The Bronx, New York, United States
Otsuka Investigational Site
Cincinnati, Ohio, United States
Otsuka Investigational Site
Cleveland, Ohio, United States
Otsuka Investigational Site
Columbus, Ohio, United States
Otsuka Investigational Site
Fairfield, Ohio, United States
Otsuka Investigational Site
Toledo, Ohio, United States
Otsuka Investigational Site
Oklahoma City, Oklahoma, United States
Otsuka Investigational Site
Bethleham, Pennsylvania, United States
Otsuka Investigational Site
Philadelphia, Pennsylvania, United States
Otsuka Investigational Site
Philadelphia, Pennsylvania, United States
Otsuka Investigational Site
West Reading, Pennsylvania, United States
Otsuka Investigational Site
Providence, Rhode Island, United States
Otsuka Investigational Site
Galveston, Texas, United States
Otsuka Investigational Site
Houston, Texas, United States
Otsuka Investigational Site
Mission, Texas, United States
Otsuka Investigational Site
San Antonio, Texas, United States
Otsuka Investigational Site
San Antonio, Texas, United States
Otsuka Investigational Site
Fairfax, Virginia, United States
Otsuka Investigational Site
Madison, Wisconsin, United States
Countries
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Other Identifiers
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156-08-275
Identifier Type: -
Identifier Source: org_study_id
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