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A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of Oral Lixivaptan Capsules in Subjects With Euvolemic Hyponatremia

Primary Purpose

Euvolemic Hyponatremia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lixivaptan
Placebo
Sponsored by
CardioKine Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Euvolemic Hyponatremia focused on measuring Euvolemic Hyponatremia, SIADH, Serum Sodium

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Written informed consent.
  2. Men or women aged 18 or older.
  3. Diagnosis of euvolemic hyponatremia (Na+ < 135 mEq/L).
  4. Willing to be observed in a monitored setting for approximately the first 8 hours following treatment initiation (first dose).
  5. In the Investigator's judgement the patient has adequate visual and auditory acuity to allow participation in the trial.

Exclusion Criteria:

  1. Pregnant or breast-feeding women, or women planning to become pregnant or to breastfeed.
  2. Overt symptoms of hyponatremia requiring immediate medical intervention (e.g., coma, seizures).
  3. Acute or transient hyponatremia (e.g., associated with head trauma, postoperative state, or use of radiotherapy and/or chemotherapy).
  4. 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.
  5. Hyponatremia in hypervolemic states (e.g., congestive heart failure). Hypervolemia is defined as a presence of increased total body water with signs of edema.
  6. Pseudohyponatremia (i.e., hyponatremia resulting from a laboratory artifact).
  7. Hypertonic hyponatremia (e.g., hyponatremia in the setting of hyperglycemia).
  8. Hyponatremia as a result of any medication that can safely be withdrawn.
  9. Hyponatremia due to hypothyroidism or adrenal insufficiency.
  10. Current diagnosis of psychogenic polydipsia.
  11. Receiving within 7 days of enrollment other medication for treatment of hyponatremia, specifically: demeclocycline, lithium carbonate, urea, or any vasopressin antagonist.
  12. Supine systolic arterial blood pressure of ≤ 90 millimeters of mercury (mmHg).
  13. Serum creatinine > 3.0 mg/dL (> 265.2 mol/L).
  14. Hypokalemia based on clinical sign/symptoms or lab findings (e.g., serum potassium < 3.5 mEq/L).
  15. Uncontrolled diabetes mellitus as defined by the Investigators (e.g., hemoglobin - glycosylated [HbA1c] > 9%).
  16. ST-segment elevation myocardial infarction (STEMI) within 30 days or active myocardial ischemia at the time of enrollment.
  17. History of cerebral vascular accident (CVA) within 30 days prior to screening.
  18. Severe malnutrition in the Investigator's judgment (e.g., body mass index [BMI] < 17).
  19. Advanced liver disease or documented diagnosis of cirrhosis or alcoholic hepatitis.
  20. Urinary tract obstruction (benign prostatic hypertrophy [BPH] allowed if non-obstructive).
  21. History of chronic drug/medication abuse within the past 6 months or current alcohol abuse.
  22. Terminally ill or moribund condition with little chance of short-term survival.
  23. Receiving vasopressin or its analogs for treatment of any condition.
  24. Known allergy to any vasopressin antagonist.
  25. Previous participation in a lixivaptan study.
  26. Recipient of any investigational treatment within 30 days prior to baseline visit.
  27. Unable to take oral medications.
  28. Significant neurological disorders (e.g., permanent neurological deficits, probable Alzheimer's disease, normal pressure hydrocephalus, Parkinsonian dementia complex, multi-infarct dementia, mixed dementia, or Huntington's disease).
  29. Conditions limiting access to water or an inability to respond to thirst (e.g., hydrophobia, or non-communicative).

Sites / Locations

  • Birmingham Nursing and Rehabilitation East
  • Healthscan Research, LLC
  • PsyPharma Clinical Research, Inc.
  • PsyPharma Clinical Research
  • Southern Arizona VA Health Care System (SAVAHCS)
  • Parkview Rehabilitation and Nursing
  • Searcy Medical Center
  • AV Institute, Inc.
  • Royal Care Nursing Home
  • Sarah S. Olelewe, MD, Inc.
  • Torrance Clinical Research
  • Olive View - UCLA Medical Center
  • Senior Care of Colorado, PC
  • Naples Institute for Clinical Research
  • Innovative Research of West Florida, Inc.
  • Jacksonville Center for CLinical Research
  • Galiz Research
  • Miami Jewish Home and Hospital for the Aged
  • Galiz Research
  • Nephrology Associates of South Miami
  • Piedmont Clinical Trials
  • Scientific Clinical Research, Inc.
  • Universal Clinical Research & Technology, Inc.
  • University Clinical Research & Technology, Inc.
  • Coastal Nephrology Associates Reserach Center
  • Executive Health and Research Associates
  • Rockdale Medicall Research Associates
  • RTR Medical Group
  • Toulon Health Care Center
  • Research Integrity, LLC
  • Four Rivers Clinical Research
  • Natchitoches Internal Medicine
  • John J. Hainkel Jr Home and Rehabilitation Center
  • Levindale Hebrew Geriatric Center and Hospital
  • LifeBridge Health, Inc./ Courtland Gardens Nursing & Rehabilitation Center
  • Stephen R. Smith
  • Genesis Clinical Research & Consulting, LLC
  • Western New England Renal & Transplant Assciates, PC
  • SLU Care Doctors Office Building
  • Millenium Psychiatric Associates
  • Mercury Street Medical Group
  • Internal Medical Associates of Grand Island, PC
  • Buffalo VA Medical Center
  • Erie County Medical Center/SUNY at Buffalo affiliate
  • Parker Jewish Institute for Health Care and Rehabilitation
  • Rochester General Hospital
  • Medical Research Development Associates, LLC
  • Three Rivers Health and Rehabilitation
  • Lillestol Research LLC
  • Valley Medical Research
  • Hilltop Physicians Inc
  • Providence Health Partners - Center for Clinical Research
  • Your Diabetes Endocrine Nutrition Group, Inc.
  • COR Clinical Research LLC
  • Northeast Clinical Research Center
  • Translational Neuroscience, LLC/Drexel University College of Medicine
  • Ilumina CLinical Associates
  • Carolina Diabetes and Kidney Center
  • Senior Adults Specialty Research
  • Memorial Hermann - Memorial City Research Center
  • South Texas Institutes of Health
  • InVisions Consultants, LLC
  • ASpen CLinical Research
  • Clinical Research and Consulting Center
  • McGuire VA Medical Center
  • Universal Research Group
  • Hospital Erasme
  • Fakultni nemocnice Ostrava Neurologicke oddeleni
  • Klinika nefrologie VFN a 1.LF UK
  • Smt G.R. Doshi & Smt K.M. Mehta Institute of Kidney Diseases & Reseacrh Cnetre (IKDRC) & Dr. H.L. Trivedi Institute of Transplantation Services (ITS)
  • Kamineni Hospitals
  • Apollo Hospitals
  • Kovai Medical Centre & Hospital
  • M. S. Ramaiah Memorial Hospital
  • Dayanand Medical College and Hospital
  • Bhatia Hospital, G-1 Ward
  • Jehangir Clinical Development Centre Pvt. Ltd.
  • Justice K. S. Hedge Charitable Hospital
  • Department of Neurology St. John's Medical College & Hospital
  • Hadassah Medical Organization, Hadassah University Hospital, Ein Karem
  • Diabetic and Endocrine Unit, Hillel Yaffe Medical Center
  • The Endocrine Institute, Rabin Medical Center, Beilinson Hospital
  • Tel Aviv Sourasky Medical Center
  • Presidio ospedaliero zona aretina, Ospedale San Donato di Arezzo
  • Medicina II, Arcispedale Santa Maria Nuova
  • SOD Clinica di Endocrinologia a Malatte del Metabolismo
  • Instituto Biomedico de Investigacion A.C.
  • Hospital General "Dr. Santiago Ramon Y Cajal" I.S.S.S.T.E.
  • Hospital Nacional Guillermo Almenara Irigoyen-EsSalud.
  • Hospital Nacional Arzobispo Loayza

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Lixivaptan

Placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 6, 2009
Last Updated
June 20, 2011
Sponsor
CardioKine Inc.
Collaborators
Cardiokine Biopharma, LLC, Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT00876798
Brief Title
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of Oral Lixivaptan Capsules in Subjects With Euvolemic Hyponatremia
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of Oral Lixivaptan Capsules in Subjects With Euvolemic Hyponatremia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
CardioKine Inc.
Collaborators
Cardiokine Biopharma, LLC, Biogen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and tolerability of oral lixivaptan capsules in subjects with Euvolemic Hyponatremia.
Detailed Description
Phase I and Phase II clinical trials have demonstrated that lixivaptan may play an important role in treating hyponatremia and the signs and symptoms of water retention associated with HF, LCWA, and SIADH. Lixivaptan was previously evaluated in disease states characterized by hyponatremia with euvolemia (SIADH) and hyponatremia combined with fluid overload (HF, LCWA). Lixivaptan demonstrated correction in serum sodium concentration together with marked aquaresis in subjects with hyponatremia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Euvolemic Hyponatremia
Keywords
Euvolemic Hyponatremia, SIADH, Serum Sodium

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
206 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Lixivaptan
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Lixivaptan
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Capsule. Subjects will be randomized (3:1) on an outpatient basis to 25 mg lixivaptan or matching placebo, once daily.
Primary Outcome Measure Information:
Title
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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%). ST-segment elevation myocardial infarction (STEMI) within 30 days or active myocardial ischemia at the time of enrollment. History of cerebral vascular accident (CVA) within 30 days prior to screening. Severe malnutrition in the Investigator's judgment (e.g., body mass index [BMI] < 17). Advanced liver disease or documented diagnosis of cirrhosis or alcoholic hepatitis. Urinary tract obstruction (benign prostatic hypertrophy [BPH] allowed if non-obstructive). History of chronic drug/medication abuse within the past 6 months or current alcohol abuse. 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 within 30 days prior to baseline visit. Unable to take oral medications. Significant neurological disorders (e.g., permanent neurological deficits, probable Alzheimer's disease, normal pressure hydrocephalus, Parkinsonian dementia complex, multi-infarct dementia, mixed dementia, or Huntington's disease). Conditions limiting access to water or an inability to respond to thirst (e.g., hydrophobia, or non-communicative).
Facility Information:
Facility Name
Birmingham Nursing and Rehabilitation East
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Healthscan Research, LLC
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36109
Country
United States
Facility Name
PsyPharma Clinical Research, Inc.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
PsyPharma Clinical Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Southern Arizona VA Health Care System (SAVAHCS)
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
Facility Name
Parkview Rehabilitation and Nursing
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72204
Country
United States
Facility Name
Searcy Medical Center
City
Searcy
State/Province
Arkansas
ZIP/Postal Code
72143
Country
United States
Facility Name
AV Institute, Inc.
City
Carson
State/Province
California
ZIP/Postal Code
90746
Country
United States
Facility Name
Royal Care Nursing Home
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Sarah S. Olelewe, MD, Inc.
City
Hawthorne
State/Province
California
ZIP/Postal Code
90250
Country
United States
Facility Name
Torrance Clinical Research
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
Facility Name
Olive View - UCLA Medical Center
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
Facility Name
Senior Care of Colorado, PC
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80014
Country
United States
Facility Name
Naples Institute for Clinical Research
City
Bonita Springs
State/Province
Florida
ZIP/Postal Code
34134
Country
United States
Facility Name
Innovative Research of West Florida, Inc.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Jacksonville Center for CLinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Galiz Research
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Miami Jewish Home and Hospital for the Aged
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Facility Name
Galiz Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33145
Country
United States
Facility Name
Nephrology Associates of South Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Piedmont Clinical Trials
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Scientific Clinical Research, Inc.
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Universal Clinical Research & Technology, Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32833
Country
United States
Facility Name
University Clinical Research & Technology, Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32833
Country
United States
Facility Name
Coastal Nephrology Associates Reserach Center
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Executive Health and Research Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Rockdale Medicall Research Associates
City
Conyers
State/Province
Georgia
ZIP/Postal Code
30094
Country
United States
Facility Name
RTR Medical Group
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31419
Country
United States
Facility Name
Toulon Health Care Center
City
Toulon
State/Province
Illinois
ZIP/Postal Code
61483
Country
United States
Facility Name
Research Integrity, LLC
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
Facility Name
Four Rivers Clinical Research
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
Natchitoches Internal Medicine
City
Natchitoches
State/Province
Louisiana
ZIP/Postal Code
71457
Country
United States
Facility Name
John J. Hainkel Jr Home and Rehabilitation Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70118
Country
United States
Facility Name
Levindale Hebrew Geriatric Center and Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
LifeBridge Health, Inc./ Courtland Gardens Nursing & Rehabilitation Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Stephen R. Smith
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21234
Country
United States
Facility Name
Genesis Clinical Research & Consulting, LLC
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
Western New England Renal & Transplant Assciates, PC
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
SLU Care Doctors Office Building
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Millenium Psychiatric Associates
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63044
Country
United States
Facility Name
Mercury Street Medical Group
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Internal Medical Associates of Grand Island, PC
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68803
Country
United States
Facility Name
Buffalo VA Medical Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Erie County Medical Center/SUNY at Buffalo affiliate
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Parker Jewish Institute for Health Care and Rehabilitation
City
New Hyde PArk
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Rochester General Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14621
Country
United States
Facility Name
Medical Research Development Associates, LLC
City
Springfield Gardens
State/Province
New York
ZIP/Postal Code
11413
Country
United States
Facility Name
Three Rivers Health and Rehabilitation
City
Windsor
State/Province
North Carolina
ZIP/Postal Code
27983
Country
United States
Facility Name
Lillestol Research LLC
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Valley Medical Research
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
Hilltop Physicians Inc
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45224
Country
United States
Facility Name
Providence Health Partners - Center for Clinical Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45439
Country
United States
Facility Name
Your Diabetes Endocrine Nutrition Group, Inc.
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
COR Clinical Research LLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Northeast Clinical Research Center
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
Translational Neuroscience, LLC/Drexel University College of Medicine
City
Conshohocken
State/Province
Pennsylvania
ZIP/Postal Code
19428
Country
United States
Facility Name
Ilumina CLinical Associates
City
Indiana
State/Province
Pennsylvania
ZIP/Postal Code
15701
Country
United States
Facility Name
Carolina Diabetes and Kidney Center
City
Sumter
State/Province
South Carolina
ZIP/Postal Code
29150
Country
United States
Facility Name
Senior Adults Specialty Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
Facility Name
Memorial Hermann - Memorial City Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
South Texas Institutes of Health
City
McAllen
State/Province
Texas
ZIP/Postal Code
78501
Country
United States
Facility Name
InVisions Consultants, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
ASpen CLinical Research
City
Orem
State/Province
Utah
ZIP/Postal Code
84058
Country
United States
Facility Name
Clinical Research and Consulting Center
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22030
Country
United States
Facility Name
McGuire VA Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Universal Research Group
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Hospital Erasme
City
Bruzelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Fakultni nemocnice Ostrava Neurologicke oddeleni
City
Ostrava
State/Province
Poruba
ZIP/Postal Code
70852
Country
Czech Republic
Facility Name
Klinika nefrologie VFN a 1.LF UK
City
Nemocnice 2
State/Province
Praha
ZIP/Postal Code
12808
Country
Czech Republic
Facility Name
Smt G.R. Doshi & Smt K.M. Mehta Institute of Kidney Diseases & Reseacrh Cnetre (IKDRC) & Dr. H.L. Trivedi Institute of Transplantation Services (ITS)
City
Asarwa
State/Province
Ahmedabad
ZIP/Postal Code
380 016
Country
India
Facility Name
Kamineni Hospitals
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500 068
Country
India
Facility Name
Apollo Hospitals
City
Tanil Nadu
State/Province
Chennai
ZIP/Postal Code
600 006
Country
India
Facility Name
Kovai Medical Centre & Hospital
City
Tamil Nadu
State/Province
Coimbatore
ZIP/Postal Code
54013
Country
India
Facility Name
M. S. Ramaiah Memorial Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560054
Country
India
Facility Name
Dayanand Medical College and Hospital
City
Tagore Nagar
State/Province
Ludhiana
ZIP/Postal Code
141 001
Country
India
Facility Name
Bhatia Hospital, G-1 Ward
City
Mumbia
State/Province
Maharashtra
ZIP/Postal Code
400 007
Country
India
Facility Name
Jehangir Clinical Development Centre Pvt. Ltd.
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411 001
Country
India
Facility Name
Justice K. S. Hedge Charitable Hospital
City
Karnataka
State/Province
Mangalore
ZIP/Postal Code
575018
Country
India
Facility Name
Department of Neurology St. John's Medical College & Hospital
City
Bangalore
ZIP/Postal Code
560034
Country
India
Facility Name
Hadassah Medical Organization, Hadassah University Hospital, Ein Karem
City
Kiryat Hadassah
State/Province
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Diabetic and Endocrine Unit, Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Name
The Endocrine Institute, Rabin Medical Center, Beilinson Hospital
City
Petah Tikvah
ZIP/Postal Code
49100
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Presidio ospedaliero zona aretina, Ospedale San Donato di Arezzo
City
Pietro Nenni
State/Province
Arezzo
ZIP/Postal Code
52100
Country
Italy
Facility Name
Medicina II, Arcispedale Santa Maria Nuova
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
Facility Name
SOD Clinica di Endocrinologia a Malatte del Metabolismo
City
Torette di Ancona
ZIP/Postal Code
60126
Country
Italy
Facility Name
Instituto Biomedico de Investigacion A.C.
City
Aguascalientes
ZIP/Postal Code
20127
Country
Mexico
Facility Name
Hospital General "Dr. Santiago Ramon Y Cajal" I.S.S.S.T.E.
City
Durango
ZIP/Postal Code
34070
Country
Mexico
Facility Name
Hospital Nacional Guillermo Almenara Irigoyen-EsSalud.
City
Lima
ZIP/Postal Code
Lima 13
Country
Peru
Facility Name
Hospital Nacional Arzobispo Loayza
City
Lima
ZIP/Postal Code
Lima 1
Country
Peru

12. IPD Sharing Statement

Learn more about this trial

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of Oral Lixivaptan Capsules in Subjects With Euvolemic Hyponatremia

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