drugset / Trial / NCT01507727
Efficacy and Safety Study of the Tolvaptan Tablets in Patients With Non-hypovolemic Non-acute Hyponatremia
Phase 2/3
Unknown
240 enrolled
Jiangsu HengRui Medicine Co., Ltd.
Beijing 302 Hospital · collabBeijing Anzhen Hospital · collabBeijing Friendship Hospital · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This drug has been developed to treat Hyponatremia. The primary purpose of this study is to verify the efficacy and safety of seven-day repeated oral administration of tolvaptan at 15, 30, and 60 mg or placebo in patients with Non-hypovolemic Non-acute Hyponatremia secondary to Congestive Heart Failure (CHF), hepatic cirrhosis or Syndrome of Inappropriate Antidiuretic Hormone (SIADH), despite receiving standard therapy. This study is being conducted in China.
Timeline
- Start
- 2012-01
- Primary completion
- 2012-09
- Completion
- 2012-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tolvaptan | Small molecule | 15 mg | Oral |
| Subject | Tolvaptan | Small molecule | 30 mg | Oral |
| Subject | Tolvaptan | Small molecule | 60 mg | Oral |
Indications
No indication recorded.