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 - Full Text View

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

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, see Learn About Clinical Studies.

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 Metabolic Diseases Water-Electrolyte Imbalance

ClinicalTrials.gov processed this record on March 03, 2015