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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01056848

Enrollment

135

Registered

2010-01-26

Start date

2010-01-31

Completion date

Unknown

Last updated

2011-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyponatremia With Excess Extracellular Fluid Volume, Hyponatremia With Normal Extracellular Fluid Volume

Keywords

Euvolemic Hyponatremia, Hypervolemic Hyponatremia, SIADH, Serum Sodium

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Secondary

Measure	Time frame
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

Countries

United States

Outcome results