Status:
COMPLETED
A Phase 2 Efficacy and Safety Study of the Tolvaptan Tablets in Patients With Non-hypovolemic Non-acute Hyponatremia
Lead Sponsor:
Otsuka Beijing Research Institute
Collaborating Sponsors:
Otsuka Pharmaceutical Co., Ltd.
Conditions:
Hypovolemic Hyponatremia
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is a randomized, double-blind, multicenter, placebo-controlled (standard therapy + placebo), phase 2 efficacy and safety study of the Tolvaptan tablets in treatment of patients with non-hypovolem...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Informed consent.
- Age:18～75 (when informed consent is obtained)，male or female.
- Non-hypovolemic and non acute hyponatremia with a Serum sodium \< 135mEq/L before randomization. (main underlying diseases include CHF, hepatic cirrhosis with edema, SIADH and others)
- In-patient subjects.
Exclusion
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
241 Patients enrolled
Trial Details
Trial ID
NCT00664014
Start Date
May 1 2008
End Date
February 1 2010
Last Update
March 25 2025
Active Locations (13)
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1
Department of Cardiology, the Third Xiangya Hospital, Central South University
Changsha, Hunan, China
2
Department of Cardiology, Xiangya Hospital, Central South University
Changsha, Hunan, China
3
Cardiology, Jilin University Second Hospital
Changchun, Jilin, China
4
Endocrinology, West China Hospital Sichuan University
Chengdu, Sichuan, China