Chronic hyponatraemia MedDRA version: 12.1 Level: LLT Classification code 10021036 Term: Hyponatraemia
Conditions
Interventions
Product Name: Lixivaptan
Product Code: Lixivaptan
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Lixivaptan
CAS Number: 168079-32-1
Current Sponsor code: VPA-985
Other descriptive name: CL-34
Sponsors
Cardiokine Biopharma LLC
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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, artifactual 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 |
|---|---|
| Main Objective: 1.To assess the safety of long-term lixivaptan use in patients previously enrolled in the parent Phase III studies. 2.To assess the effect of lixivaptan re-administration. 3.To gather information on the natural history of hyponatremia in the context of lixivaptan therapy and underlying disease states. ;Secondary Objective: 1.To demonstrate that after 28 weeks of open-label lixivaptan treatment, improvements in the time to complete the Trail Making Test (Part B) will be maintained compared to baseline. 2.To demonstrate that after 28 weeks of open-label lixivaptan administration, improvements in the Medical Outcomes Survey will be maintained compared to baseline. ;Primary end point(s): Safety: Adverse event (AE) reports will be summarized; clinical labs and their differences from baseline will be summarized. Efficacy: Change from baseline in serum sodium concentrations | — |
Countries
Belgium, Czech Republic, Germany
Outcome results
None listed