drugset / Trial / NCT00550459
Effects of Titrated Oral Tolvaptan 15-60 mg Once Daily (QD) on Cognitive and Neurological Function in Elderly Hyponatremic Patients
Phase 3
Completed
57 enrolled
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka Pharmaceutical Co., Ltd. · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
Demonstrate an improvement in the composite scores of validated neurocognitive tests in elderly subjects with chronic sub-clinical (i.e., asymptomatic) hyponatremia.
Timeline
- Start
- 2007-08
- Primary completion
- 2009-02
- Completion
- 2009-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Tolvaptan | Small molecule | 15 mg | Oral |
| Comparator | Tolvaptan | Small molecule | 30 mg | Oral |
| Comparator | Tolvaptan | Small molecule | 60 mg | Oral |
Indications
No indication recorded.