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
This study has been completed.
Sponsor:
CardioKine Inc.
Collaborators:
Cardiokine Biopharma, LLC
Biogen Idec
Information provided by:
CardioKine Inc.
ClinicalTrials.gov Identifier:
NCT01056848
First received: January 22, 2010
Last updated: June 20, 2011
Last verified: June 2011
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Purpose
To evaluate the overall safety and continued efficacy of oral lixivaptan capsules in subjects with euvolemic and hypervolemic hyponatremia
| Condition | Phase |
|---|---|
|
Hyponatremia With Normal Extracellular Fluid Volume Hyponatremia With Excess Extracellular Fluid Volume |
Phase 3 |
| Study Type: | Observational |
| Study Design: | 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 |
Further study details as provided by CardioKine Inc.:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
| Enrollment: | 135 |
| Study Start Date: | January 2010 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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
|
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 patients with hyponatremia.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients with euvolemic or hypervolemic hyponatremia and who were enrolled in a randomized, blinded, placebo-controlled Phase III lixivaptan study of hyponatremia (CK-LX3401, CK-LX3405, or CK-LX3430)
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01056848
Locations
| 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 | |
Sponsors and Collaborators
CardioKine Inc.
Cardiokine Biopharma, LLC
Biogen Idec
More Information
No publications provided
| Responsible Party: | Cesare Orlandi, MD, Cardiokine Biopharma, LLC |
| ClinicalTrials.gov Identifier: | NCT01056848 History of Changes |
| Other Study ID Numbers: | CK-LX3431 |
| Study First Received: | January 22, 2010 |
| Last Updated: | June 20, 2011 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by CardioKine Inc.:
|
Euvolemic Hyponatremia Hypervolemic Hyponatremia SIADH Serum Sodium |
Additional relevant MeSH terms:
|
Hyponatremia Water-Electrolyte Imbalance Metabolic Diseases |
ClinicalTrials.gov processed this record on May 22, 2013