Ongoing hyponatraemia in euvolemic and hypervolemic states MedDRA version: 7 Level: 1.1 Classification code 10021036
Conditions
Interventions
Product Name: Tolvaptan
Product Code: OPC-41061
Pharmaceutical Form: Tablet
Product Name: Tolvaptan
Product Code: OPC-41061
Pharmaceutical Form: Tablet
Sponsors
Otsuka Maryland Research Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age greater than or equal to 18 years. 2. Ability to provide informed consent or assesnt. 3. Prior successful participation in a tolvaptan hyponatraemia 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 qauaretic agent may present adn undue risk to the patient. 2. Hyponatraemia which is acute, reversible, artifactual or due to conditions not associated with vasopressin excess or likely to repond to aquaretic therapy. 3. Hyponatraemia due to reversible medical condition or therapy. 4. Conditions associated with an independent imminent risk of morbidity and mortality. 5. Conditions which confound the assessment of end points.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The efficay of tolvaptan will be measured. Study drug compliance, dosage adminsitered, serum levels and clinical laboratory ,easurements will be monitored and summarised.;Primary end point(s): Safety and long-term therapy will be assessed qualitatively and quantitavely using descriptive statistics of adverse events, vital signs (weight, HR and BP), and local electrocardiograms (baseline, post dose 8 hours, 1 day, 2 and 26 weeks and at end of study) and local clinical lab testing of critical electrolytes (sodium, chloride, potassium), glucose, renal function (serum creatinine, BUN/Blood nitrogen), liver functions (AST, ALT, total bilirubin). cell counts (RBC or haemoglobin/haematocrit, WBC, platelet) and coagulation parameters (PTT, PT and/or INR);Main Objective: To assess the safety of long-term tolvaptan use in patients previously enrolled in shorter-term Phase 3 studies and gather information on the natural history of hyponatraemia in the context of tolvaptan therapy and underlying disease states. | — |
Countries
Czech Republic, Hungary, Italy, Spain
Outcome results
None listed