International, Multicenter Study of a Twenty-eight Week, Open-label, Titrated Oral Lixivaptan Administration in Patients With Chronic Hyponatremia: Extension to Studies CK-LX3401, 3405, and 3430
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01056848 |
Recruitment Status :
Completed
First Posted : January 26, 2010
Last Update Posted : June 21, 2011
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease |
---|
Hyponatremia With Normal Extracellular Fluid Volume Hyponatremia With Excess Extracellular Fluid Volume |
Study Type : | Observational |
Actual Enrollment : | 135 participants |
Observational Model: | Cohort |
Time Perspective: | Cross-Sectional |
Official Title: | International, Multicenter Study of a Twenty-eight Week, Open-label, Titrated Oral Lixivaptan Administration in Patients With Chronic Hyponatremia: Extension to Studies CK-LX3401, 3405, and 3430 |
Study Start Date : | January 2010 |
Actual Primary Completion Date : | June 2011 |
Group/Cohort |
---|
CK-LX3401
Patients with euvolemic or hypervolemic hyponatremia and who were enrolled in a randomized, blinded, placebo-controlled Phase III lixivaptan study of hyponatremia.
|
CK-LX3405
Patients with euvolemic or hypervolemic hyponatremia and who were enrolled in a randomized, blinded, placebo-controlled Phase III lixivaptan study of hyponatremia
|
CK-LX3430
Patients with euvolemic or hypervolemic hyponatremia and who were enrolled in a randomized, blinded, placebo-controlled Phase III lixivaptan study of hyponatremia
|
- To assess the safety of long-term lixivaptan use in patients who were previously enrolled in one of the 3 Phase III trials. [ Time Frame: 28 weeks ]
- To demonstrate that after open-label lixivaptan treatment: improvements in the time to complete the TMT-B will be maintained compared to baseline, and improvements in the Medical Outcomes Survey will be maintained compared to baseline. [ Time Frame: 28 weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Men and women 18 years of age or older
- Ability to provide informed consent or assent
- Prior participation in a lixivaptan hyponatremia trial with evidence of continued need or desire for therapy
Exclusion Criteria:
- A current medical condition where long-term treatment with an aquaretic agent may present an undue risk to the patient
- Hyponatremia which is acute, reversible, artificial or due to conditions not associated with vasopressin excess or likely to respond to aquaretic therapy
- Hyponatremia due to reversible medical condition or therapy
- Conditions associated with an independent imminent risk of morbidity and mortality

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01056848
United States, California | |
Torrance Clinical Research | |
Lomita, California, United States, 90717 | |
United States, Florida | |
Innovative Research of West Florida | |
Clearewater, Florida, United States, 33756 | |
Fleming Island Center for Clinical Research | |
Fleming Island, Florida, United States, 32003 | |
Jacksonville Center for Clinical Research | |
Jacksonville, Florida, United States, 32216 | |
United States, Missouri | |
Millenium Psychiatric Associates, LLC | |
Creve Cour, Missouri, United States, 63141 | |
United States, Nebraska | |
Internal Medical Associates of Grand Island, PC | |
Grand Island, Nebraska, United States, 68803 |
Responsible Party: | Cesare Orlandi, MD, Cardiokine Biopharma, LLC |
ClinicalTrials.gov Identifier: | NCT01056848 History of Changes |
Other Study ID Numbers: |
CK-LX3431 |
First Posted: | January 26, 2010 Key Record Dates |
Last Update Posted: | June 21, 2011 |
Last Verified: | June 2011 |
Euvolemic Hyponatremia Hypervolemic Hyponatremia SIADH Serum Sodium |
Hyponatremia Water-Electrolyte Imbalance Metabolic Diseases |