Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Oral Lixivaptan Capsules in Subject With Euvolemic Hyponatremia
NCT ID: NCT00660959
Last Updated: 2011-06-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
106 participants
INTERVENTIONAL
2008-04-30
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
TRIPLE
Study Groups
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Active Comparator
lixivaptan
lixivaptan
oral capsule
Placebo
placebo
placebo
oral capsule
Interventions
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lixivaptan
oral capsule
placebo
oral capsule
Eligibility Criteria
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Inclusion Criteria
* Men or women aged 18 or older
* Diagnosis of euvolemic hyponatremia (120 ≤ Na+\<130 mEq/L)
* Hospitalized or willing to be admitted to a monitored setting for approximately the first 48 hours of treatment
Exclusion Criteria
* Symptomatic hyponatremia (e.g., lethargy, coma, seizures, changes in mental status attributable to hyponatremia)
* Acute or transient hyponatremia (e.g., associated with head trauma or postoperative state)
* Hyponatremia in hypovolemic states. Hypovolemic hyponatremia is defined as the presence of clinical evidence of extracellular fluid volume depletion
* Hyponatremia as a result of any medication that can safely be withdrawn
* Hyponatremia due to hypothyroidism or adrenal insufficiency
* Diagnosis of psychogenic polydipsia
* Receiving within 7 days of enrollment, other medication for treatment of hyponatremia specifically: demeclocycline, lithium carbonate, urea, or conivaptan
* Use of radiotherapy and chemotherapy within 2 wks of randomization
* Likely to require, or to receive IV saline for correction of symptomatic or asymptomatic severe hyponatremia during the course of the study
* Supine systolic arterial blood pressure of ≤ 90 mmHg
* Serum creatinine \>3.0 mg/dL
* History of uncontrolled type 2 diabetes mellitus
* Severe pulmonary artery hypertension: patients whose condition is expected to deteriorate with sudden shifts in fluid volumes and cardiac filling pressures
* Established diagnosis of New York Heart Association (NYHA) class III or IV heart failure
* History of myocardial infarction, unstable angina or evidence of active ischemia within 30 days prior to screening
* History of cerebral vascular accident (CVA) within 60 days prior to screening
* Established diagnosis of nephrotic syndrome
* Advanced liver disease or documented diagnosis of cirrhosis or alcoholic hepatitis
* Urinary tract obstruction (benign prostatic hypertrophy \[BPH\] allowed if non-obstructive)
* History of alcohol abuse or illicit drug use within the past 6 months
* Terminally ill or moribund condition with little chance of short-term survival
* Receiving vasopressin or its analogs for treatment of any condition
* Known allergy to any vasopressin antagonist
* Previous participation in a lixivaptan study
* Recipient of any investigational treatment (drug or device) within 30 days prior to baseline visit
* Unable to take oral medications
18 Years
ALL
No
Sponsors
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Cardiokine Biopharma, LLC
INDUSTRY
Biogen
INDUSTRY
CardioKine Inc.
INDUSTRY
Responsible Party
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Cardiokine, Inc
Locations
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Research Site 1
Mobile, Alabama, United States
PsyPharma Global
Phoenix, Arizona, United States
Research Site
Los Angeles, California, United States
Research Site 1
Los Angeles, California, United States
Research Site 1
Roseville, California, United States
Research Site
Aurora, Colorado, United States
The George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, United States
Healthcare Clinical Data, Inc
North Miami, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
Research Site
Augusta, Georgia, United States
RTR Medical Group
Savannah, Georgia, United States
Research Site
Chicago, Illinois, United States
Research Site 1
Iowa City, Iowa, United States
Four Rivers Clinical Research, Inc.
Paducah, Kentucky, United States
Louisiana Research Associates, Inc.
New Orleans, Louisiana, United States
Research Site
Belmont, Massachusetts, United States
Research Site
Boston, Massachusetts, United States
Research Site
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Research Site
Kansas City, Missouri, United States
Research Site 1
Las Vegas, Nevada, United States
Research Site 1
Albany, New York, United States
Erie County Medical Center
Buffalo, New York, United States
Research Site
New York, New York, United States
Three Rivers Health and Rehabilitation
Windsor, North Carolina, United States
Atrium Medical Center
Middletown, Ohio, United States
Kettlie Joseph Daniels MD, Inc
Toledo, Ohio, United States
Research Site 1
Camp Hill, Pennsylvania, United States
Research Site 1
Doylestown, Pennsylvania, United States
Research Site
Norristown, Pennsylvania, United States
Research Site 1
Philadelphia, Pennsylvania, United States
Research Site
Providence, Rhode Island, United States
Research Site 1
Columbia, South Carolina, United States
SunStar Geriatrics Healthcare
Georgetown, Texas, United States
Clinical Trial Network
Houston, Texas, United States
Aspen Clinical Research
Orem, Utah, United States
The Glennan Center for Geriatrics and Gerontology
Norfolk, Virginia, United States
Internal Medicine Northwest
Tacoma, Washington, United States
UZ Gasthulsberg
Leuven, , Belgium
Centre Hospitalier de Tubize
Tubize, , Belgium
Research SIte
Greenfield Park, Quebec, Canada
Research Site 1
Montreal, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Dresden, Germany, Germany
Research Site
Hanover, Hannover, Germany
Research Site
Magdeburg, Magdeburg, Germany
Research Site
Berlin, , Germany
Research Site
Berlin, , Germany
Research Site
Giessen, , Germany
Research Site
Heidelberg, , Germany
Research SIte
Konstanz, , Germany
Research Site
München, , Germany
Research Site
Würzburg, , Germany
Baby Memorial Hospital
Calicut, Kerala, India
Poona Hospital and Research Centre
Pune, Maharashtra, India
Vidya Sagar Institute of Mental Health and Neurosciences
New Delhi, New Delhi, India
Sir Ganga Ram Hospital
Old Rajinder Nagar, New Delhi, India
Deenanath Mengeshkar Hospital & Research Centre
Erandawane, Pune, India
Fortis Escorts Hospital
Jaipur, Rajasthan, India
Research Site 1
Podlaski, Poland, Poland
Research Site 1
Warsaw, Poland, Poland
Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II
Zamość, Zamosc, Poland
Research Site
Bydgoszcz, , Poland
Research Site 1
Ciechanów, , Poland
Research Site
Katowice, , Poland
Research Site 1
Lodz, , Poland
Research Site
Lublin, , Poland
Research Site 1
Warsaw, , Poland
Research Site
Warsaw, , Poland
Research Site 1
Warsaw, , Poland
Niepubliczny Zaklad Opieki Zdrowotney
Wilgury, Łódź Voivodeship, Poland
Countries
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Other Identifiers
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CK-LX3405
Identifier Type: -
Identifier Source: org_study_id
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