Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Oral Lixivaptan Capsules in Subject With Euvolemic Hyponatremia
1 other identifier
interventional
106
6 countries
71
Brief Summary
The present study is designed to confirm and extend the observation from previous studies that lixivaptan therapy corrects hyponatremia, in euvolemic subject, including subjects with SIADH.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
71 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 15, 2008
CompletedFirst Posted
Study publicly available on registry
April 18, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedJune 28, 2011
November 1, 2010
2.2 years
April 15, 2008
June 20, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Average daily area under the curve (AUC) of change from baseline in serum sodium concentrations up to 72 hrs in lixivaptan treated subjects compared to placebo
60 days
Secondary Outcomes (3)
Change from baseline in serum sodium on Day 30
60 days
Percentage of subjects achieving normalized serum sodium (Na+ ≥ 135 mEq/L)
60 days
Time to first normalization of serum sodium (Na+≥135 mEq/L)
60 days
Study Arms (2)
Active Comparator
EXPERIMENTALlixivaptan
Placebo
PLACEBO COMPARATORplacebo
Interventions
Eligibility Criteria
You may qualify if:
- Written informed consent
- 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
You may not qualify if:
- Pregnant or breast-feeding women, or women planning to become pregnant or to breastfeed
- 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
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CardioKine Inc.lead
- Cardiokine Biopharma, LLCcollaborator
- Biogencollaborator
Study Sites (71)
Research Site 1
Mobile, Alabama, 36617, United States
PsyPharma Global
Phoenix, Arizona, 85050, United States
Research Site
Los Angeles, California, 90033, United States
Research Site 1
Los Angeles, California, 90073, United States
Research Site 1
Roseville, California, 95661, United States
Research Site
Aurora, Colorado, 80045, United States
The George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, 20037, United States
Healthcare Clinical Data, Inc
North Miami, Florida, 33161, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
Research Site
Augusta, Georgia, 30912, United States
RTR Medical Group
Savannah, Georgia, 31419, United States
Research Site
Chicago, Illinois, 60612, United States
Research Site 1
Iowa City, Iowa, 52242, United States
Four Rivers Clinical Research, Inc.
Paducah, Kentucky, 42003, United States
Louisiana Research Associates, Inc.
New Orleans, Louisiana, 70114, United States
Research Site
Belmont, Massachusetts, 02478, United States
Research Site
Boston, Massachusetts, 02135, United States
Research Site
Boston, Massachusetts, 02212, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Research Site
Kansas City, Missouri, 64128, United States
Research Site 1
Las Vegas, Nevada, 89106, United States
Research Site 1
Albany, New York, 12208, United States
Erie County Medical Center
Buffalo, New York, 14215, United States
Research Site
New York, New York, 10016, United States
Three Rivers Health and Rehabilitation
Windsor, North Carolina, 27983, United States
Atrium Medical Center
Middletown, Ohio, 45005, United States
Kettlie Joseph Daniels MD, Inc
Toledo, Ohio, 43609, United States
Research Site 1
Camp Hill, Pennsylvania, 17011, United States
Research Site 1
Doylestown, Pennsylvania, 18901, United States
Research Site
Norristown, Pennsylvania, 19401, United States
Research Site 1
Philadelphia, Pennsylvania, 19104, United States
Research Site
Providence, Rhode Island, 02903, United States
Research Site 1
Columbia, South Carolina, 29209, United States
SunStar Geriatrics Healthcare
Georgetown, Texas, 78626, United States
Clinical Trial Network
Houston, Texas, 77074, United States
Aspen Clinical Research
Orem, Utah, 84058, United States
The Glennan Center for Geriatrics and Gerontology
Norfolk, Virginia, 23507, United States
Internal Medicine Northwest
Tacoma, Washington, 98405, United States
UZ Gasthulsberg
Leuven, 3000, Belgium
Centre Hospitalier de Tubize
Tubize, 1480, Belgium
Research SIte
Greenfield Park, Quebec, J4V 2H1, Canada
Research Site 1
Montreal, Quebec, H1T 2M4, Canada
Research Site
Montreal, Quebec, H4J 1C5, Canada
Research Site
Dresden, Germany, 01307, Germany
Research Site
Hanover, Hannover, 30167, Germany
Research Site
Magdeburg, Magdeburg, 39120, Germany
Research Site
Berlin, 12200, Germany
Research Site
Berlin, 13353, Germany
Research Site
Giessen, 35392, Germany
Research Site
Heidelberg, 69120, Germany
Research SIte
Konstanz, 78464, Germany
Research Site
München, 80336, Germany
Research Site
Würzburg, 97080, Germany
Baby Memorial Hospital
Calicut, Kerala, 673004, India
Poona Hospital and Research Centre
Pune, Maharashtra, 411 030, India
Vidya Sagar Institute of Mental Health and Neurosciences
New Delhi, New Delhi, 110 065, India
Sir Ganga Ram Hospital
Old Rajinder Nagar, New Delhi, 110060, India
Deenanath Mengeshkar Hospital & Research Centre
Erandawane, Pune, 411 004, India
Fortis Escorts Hospital
Jaipur, Rajasthan, 302017, India
Research Site 1
Podlaski, Poland, 08-300, Poland
Research Site 1
Warsaw, Poland, Poland
Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II
Zamość, Zamosc, 22-400, Poland
Research Site
Bydgoszcz, 85-094, Poland
Research Site 1
Ciechanów, 06400, Poland
Research Site
Katowice, 40-027, Poland
Research Site 1
Lodz, 90-153, Poland
Research Site
Lublin, 20-954, Poland
Research Site 1
Warsaw, 02-097, Poland
Research Site
Warsaw, 02-097, Poland
Research Site 1
Warsaw, 02-507, Poland
Niepubliczny Zaklad Opieki Zdrowotney
Wilgury, Łódź Voivodeship, 90-302, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 15, 2008
First Posted
April 18, 2008
Study Start
April 1, 2008
Primary Completion
June 1, 2010
Last Updated
June 28, 2011
Record last verified: 2010-11