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| Name | Class |
|---|---|
| Cardiokine Biopharma, LLC | INDUSTRY |
| Biogen | INDUSTRY |
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The purpose of this study is to evaluate the safety and tolerability of oral lixivaptan capsules in subjects with Euvolemic Hyponatremia.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Lixivaptan |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lixivaptan | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Nursing and Rehabilitation East | Birmingham | Alabama | 35205 | United States | ||
| Healthscan Research, LLC |
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| Placebo | Drug | Capsule. Subjects will be randomized (3:1) on an outpatient basis to 25 mg lixivaptan or matching placebo, once daily. |
|
| 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 |
| ID | Term |
|---|---|
| D007177 | Inappropriate ADH Syndrome |
| ID | Term |
|---|---|
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C409452 | lixivaptan |
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