A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of Oral Lixivaptan Capsules in Subjects With Euvolemic Hyponatremia
1 other identifier
interventional
206
8 countries
90
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of oral lixivaptan capsules in subjects with Euvolemic Hyponatremia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
90 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
First Submitted
Initial submission to the registry
April 6, 2009
CompletedFirst Posted
Study publicly available on registry
April 7, 2009
CompletedStudy Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedJune 28, 2011
November 1, 2010
1.4 years
April 6, 2009
June 20, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To demonstrate that lixivaptan is safe and effective in achieving and maintaining increased serum sodium concentration in subjects with SIADH and other conditions of euvolemic hyponatremia.
6 months
Secondary Outcomes (1)
If lixivaptan demonstrates improvement in serum sodium, % of subjects achieving normalized serum sodium, % of subjects requiring fluid restriction, prevention of worsening hyponatremia, and the change from baseline to complete TMT-B.
6 months
Study Arms (2)
1
EXPERIMENTALLixivaptan
2
PLACEBO COMPARATORPlacebo
Interventions
Capsules, 25mg lixivaptan or matching placebo once daily. Study medication can be titrated up to 50mg or 100mg once daily. Acceptable dosages are once daily administration of 25mg, 50mg, or 100mg as a single dose.
Capsule. Subjects will be randomized (3:1) on an outpatient basis to 25 mg lixivaptan or matching placebo, once daily.
Eligibility Criteria
You may qualify if:
- Written informed consent.
- Men or women aged 18 or older.
- Diagnosis of euvolemic hyponatremia (Na+ \< 135 mEq/L).
- Willing to be observed in a monitored setting for approximately the first 8 hours following treatment initiation (first dose).
- In the Investigator's judgement the patient has adequate visual and auditory acuity to allow participation in the trial.
You may not qualify if:
- Pregnant or breast-feeding women, or women planning to become pregnant or to breastfeed.
- Overt symptoms of hyponatremia requiring immediate medical intervention (e.g., coma, seizures).
- Acute or transient hyponatremia (e.g., associated with head trauma, postoperative state, or use of radiotherapy and/or chemotherapy).
- Hyponatremia in hypovolemic states (e.g., due to fluid loss through vomiting, diarrhea, burns, etc.). Hypovolemic hyponatremia is defined as the presence of clinical evidence of extracellular fluid volume depletion.
- Hyponatremia in hypervolemic states (e.g., congestive heart failure). Hypervolemia is defined as a presence of increased total body water with signs of edema.
- Pseudohyponatremia (i.e., hyponatremia resulting from a laboratory artifact).
- Hypertonic hyponatremia (e.g., hyponatremia in the setting of hyperglycemia).
- Hyponatremia as a result of any medication that can safely be withdrawn.
- Hyponatremia due to hypothyroidism or adrenal insufficiency.
- Current diagnosis of psychogenic polydipsia.
- Receiving within 7 days of enrollment other medication for treatment of hyponatremia, specifically: demeclocycline, lithium carbonate, urea, or any vasopressin antagonist.
- Supine systolic arterial blood pressure of ≤ 90 millimeters of mercury (mmHg).
- Serum creatinine \> 3.0 mg/dL (\> 265.2 mol/L).
- Hypokalemia based on clinical sign/symptoms or lab findings (e.g., serum potassium \< 3.5 mEq/L).
- Uncontrolled diabetes mellitus as defined by the Investigators (e.g., hemoglobin - glycosylated \[HbA1c\] \> 9%).
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CardioKine Inc.lead
- Cardiokine Biopharma, LLCcollaborator
- Biogencollaborator
Study Sites (90)
Birmingham Nursing and Rehabilitation East
Birmingham, Alabama, 35205, United States
Healthscan Research, LLC
Montgomery, Alabama, 36109, United States
PsyPharma Clinical Research, Inc.
Phoenix, Arizona, 85050, United States
PsyPharma Clinical Research
Phoenix, Arizona, 85050, United States
Southern Arizona VA Health Care System (SAVAHCS)
Tucson, Arizona, 85723, United States
Parkview Rehabilitation and Nursing
Little Rock, Arkansas, 72204, United States
Searcy Medical Center
Searcy, Arkansas, 72143, United States
AV Institute, Inc.
Carson, California, 90746, United States
Royal Care Nursing Home
Fountain Valley, California, 92708, United States
Sarah S. Olelewe, MD, Inc.
Hawthorne, California, 90250, United States
Torrance Clinical Research
Lomita, California, 90717, United States
Olive View - UCLA Medical Center
Sylmar, California, 91342, United States
Senior Care of Colorado, PC
Aurora, Colorado, 80014, United States
Naples Institute for Clinical Research
Bonita Springs, Florida, 34134, United States
Innovative Research of West Florida, Inc.
Clearwater, Florida, 33756, United States
Jacksonville Center for CLinical Research
Jacksonville, Florida, 32216, United States
Miami Jewish Home and Hospital for the Aged
Miami, Florida, 33137, United States
Galiz Research
Miami, Florida, 33145, United States
Nephrology Associates of South Miami
Miami, Florida, 33173, United States
Galiz Research
Miami Springs, Florida, 33166, United States
Piedmont Clinical Trials
North Miami, Florida, 33161, United States
Scientific Clinical Research, Inc.
North Miami, Florida, 33161, United States
Universal Clinical Research & Technology, Inc.
Orlando, Florida, 32833, United States
University Clinical Research & Technology, Inc.
Orlando, Florida, 32833, United States
Coastal Nephrology Associates Reserach Center
Port Charlotte, Florida, 33952, United States
Executive Health and Research Associates
Atlanta, Georgia, 30342, United States
Rockdale Medicall Research Associates
Conyers, Georgia, 30094, United States
RTR Medical Group
Savannah, Georgia, 31419, United States
Toulon Health Care Center
Toulon, Illinois, 61483, United States
Research Integrity, LLC
Owensboro, Kentucky, 42303, United States
Four Rivers Clinical Research
Paducah, Kentucky, 42003, United States
Natchitoches Internal Medicine
Natchitoches, Louisiana, 71457, United States
John J. Hainkel Jr Home and Rehabilitation Center
New Orleans, Louisiana, 70118, United States
Levindale Hebrew Geriatric Center and Hospital
Baltimore, Maryland, 21215, United States
LifeBridge Health, Inc./ Courtland Gardens Nursing & Rehabilitation Center
Baltimore, Maryland, 21215, United States
Stephen R. Smith
Baltimore, Maryland, 21234, United States
Genesis Clinical Research & Consulting, LLC
Fall River, Massachusetts, 02720, United States
Western New England Renal & Transplant Assciates, PC
Springfield, Massachusetts, 01107, United States
Millenium Psychiatric Associates
St Louis, Missouri, 63044, United States
SLU Care Doctors Office Building
St Louis, Missouri, 63110, United States
Mercury Street Medical Group
Butte, Montana, 59701, United States
Internal Medical Associates of Grand Island, PC
Grand Island, Nebraska, 68803, United States
Buffalo VA Medical Center
Buffalo, New York, 14215, United States
Erie County Medical Center/SUNY at Buffalo affiliate
Buffalo, New York, 14215, United States
Parker Jewish Institute for Health Care and Rehabilitation
New Hyde Park, New York, 11040, United States
Rochester General Hospital
Rochester, New York, 14621, United States
Medical Research Development Associates, LLC
Springfield Gardens, New York, 11413, United States
Three Rivers Health and Rehabilitation
Windsor, North Carolina, 27983, United States
Lillestol Research LLC
Fargo, North Dakota, 58103, United States
Valley Medical Research
Centerville, Ohio, 45459, United States
Hilltop Physicians Inc
Cincinnati, Ohio, 45224, United States
Providence Health Partners - Center for Clinical Research
Dayton, Ohio, 45439, United States
Your Diabetes Endocrine Nutrition Group, Inc.
Mentor, Ohio, 44060, United States
COR Clinical Research LLC
Oklahoma City, Oklahoma, 73103, United States
Northeast Clinical Research Center
Bethlehem, Pennsylvania, 18017, United States
Translational Neuroscience, LLC/Drexel University College of Medicine
Conshohocken, Pennsylvania, 19428, United States
Ilumina CLinical Associates
Indiana, Pennsylvania, 15701, United States
Carolina Diabetes and Kidney Center
Sumter, South Carolina, 29150, United States
Senior Adults Specialty Research
Austin, Texas, 78757, United States
Memorial Hermann - Memorial City Research Center
Houston, Texas, 77024, United States
South Texas Institutes of Health
McAllen, Texas, 78501, United States
InVisions Consultants, LLC
San Antonio, Texas, 78229, United States
ASpen CLinical Research
Orem, Utah, 84058, United States
Clinical Research and Consulting Center
Fairfax, Virginia, 22030, United States
McGuire VA Medical Center
Richmond, Virginia, 23249, United States
Universal Research Group
Tacoma, Washington, 98405, United States
Hospital Erasme
Bruzelles, Bruzelles, 1070, Belgium
Fakultni nemocnice Ostrava Neurologicke oddeleni
Ostrava, Poruba, 70852, Czechia
Klinika nefrologie VFN a 1.LF UK
Nemocnice 2, Prague, 12808, Czechia
Smt G.R. Doshi & Smt K.M. Mehta Institute of Kidney Diseases & Reseacrh Cnetre (IKDRC) & Dr. H.L. Trivedi Institute of Transplantation Services (ITS)
Asarwa, Ahmedabad, 380 016, India
Kamineni Hospitals
Hyderabad, Andhra Pradesh, 500 068, India
Apollo Hospitals
Tanil Nadu, Chennai, 600 006, India
Kovai Medical Centre & Hospital
Tamil Nadu, Coimbatore, 54013, India
M. S. Ramaiah Memorial Hospital
Bangalore, Karnataka, 560054, India
Dayanand Medical College and Hospital
Tagorenagar, Ludhiana, 141 001, India
Bhatia Hospital, G-1 Ward
Mumbia, Maharashtra, 400 007, India
Jehangir Clinical Development Centre Pvt. Ltd.
Pune, Maharashtra, 411 001, India
Justice K. S. Hedge Charitable Hospital
Karnataka, Mangalore, 575018, India
Department of Neurology St. John's Medical College & Hospital
Bangalore, 560034, India
Hadassah Medical Organization, Hadassah University Hospital, Ein Karem
Kiryat Hadassah, Jerusalem, 91120, Israel
Diabetic and Endocrine Unit, Hillel Yaffe Medical Center
Hadera, 38100, Israel
The Endocrine Institute, Rabin Medical Center, Beilinson Hospital
Petah Tikvah, 49100, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
Presidio ospedaliero zona aretina, Ospedale San Donato di Arezzo
Pietro Nenni, Arezzo, 52100, Italy
SOD Clinica di Endocrinologia a Malatte del Metabolismo
Torette Di Ancona, Torette Di Ancona, 60126, Italy
Medicina II, Arcispedale Santa Maria Nuova
Reggio Emilia, 42100, Italy
Hospital General "Dr. Santiago Ramon Y Cajal" I.S.S.S.T.E.
Durango, Mexico, 34070, Mexico
Instituto Biomedico de Investigacion A.C.
Aguascalientes, 20127, Mexico
Hospital Nacional Guillermo Almenara Irigoyen-EsSalud.
Lima, Peru, Lima 13, Peru
Hospital Nacional Arzobispo Loayza
Lima, Peru, Lima 1, Peru
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 6, 2009
First Posted
April 7, 2009
Study Start
June 1, 2009
Primary Completion
November 1, 2010
Last Updated
June 28, 2011
Record last verified: 2010-11