International, Multicenter, Study of One-Year, Open-Label, Titrated Oral Tolvaptan Tablet Administration in Patients With Chronic Hyponatremia Extention to Studies 156-02-235 and 156-03-238 to Asses One-Year Safety.
- Conditions
- Ongoing Hyponatremia in euvolemic and Hypervolemic states.MedDRA version: 6.1Level: PTClassification code 10021036
- Registration Number
- EUCTR2004-000452-16-IT
- Lead Sponsor
- OTSUKA MARYLAND RESEARCH INSTITUTE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
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
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: ;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method