Skip to main content
OpenTrials
Completed

NCT Number: NCT01056848

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hyponatremia With Normal Extracellular Fluid Volume Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hyponatremia With Excess Extracellular Fluid Volume Hypothalamic Diseases Inappropriate ADH Syndrome Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Pituitary Diseases Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Torrance Clinical Research, Lomita, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

CardioKine Inc.

Industry

Collaborators

  • Biogen
  • Cardiokine Biopharma, LLC

Registry information

Important dates

Study start
2010
Primary completion
2011
First posted
Jan 26, 2010
Registry last updated
Jun 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.