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

Hyponatremia With Excess Extracellular Fluid Volume Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01056848
• Other study ID #: CK-LX3431
• Status: Completed
• Phase: Phase 3
• First received: January 22, 2010
• Last updated: June 20, 2011
• Start date: January 2010

Study information

• Verified date: June 2011
• Source: CardioKine Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

To evaluate the overall safety and continued efficacy of oral lixivaptan capsules in subjects with euvolemic and hypervolemic hyponatremia

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Men and women 18 years of age or older

2. Ability to provide informed consent or assent

3. Prior participation in a lixivaptan hyponatremia trial with evidence of continued need or desire for therapy

Exclusion Criteria:

1. A current medical condition where long-term treatment with an aquaretic agent may present an undue risk to the patient

2. Hyponatremia which is acute, reversible, artificial or due to conditions not associated with vasopressin excess or likely to respond to aquaretic therapy

3. Hyponatremia due to reversible medical condition or therapy

4. Conditions associated with an independent imminent risk of morbidity and mortality

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Hyponatremia
• Hyponatremia With Excess Extracellular Fluid Volume
• Hyponatremia With Normal Extracellular Fluid Volume

Locations

Country	Name	City	State
United States	Innovative Research of West Florida	Clearewater	Florida
United States	Millenium Psychiatric Associates, LLC	Creve Cour	Missouri
United States	Fleming Island Center for Clinical Research	Fleming Island	Florida
United States	Internal Medical Associates of Grand Island, PC	Grand Island	Nebraska
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Torrance Clinical Research	Lomita	California

Sponsors (3)

Lead Sponsor	Collaborator
CardioKine Inc.	Biogen, Cardiokine Biopharma, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the safety of long-term lixivaptan use in patients who were previously enrolled in one of the 3 Phase III trials.		28 weeks	Yes
Secondary	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.		28 weeks	Yes