International, Multi-Centre, Study of One year, Open Label, Titrated Oral Tolvaptan Tablet Administration in Patients with Chronic Hyponatraemia: Extension to Studies 156-02-235 and 156-03-238 to assess One-year safety. - Salt Water Trial

• Conditions: Ongoing hyponatraemia in euvolemic and hypervolemic states; MedDRA version: 7Level: 1.1Classification code 10021036

• Registration Number: EUCTR2004-000452-16-HU
• Lead Sponsor: Otsuka Maryland Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07-12
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified