A Phase 2 Efficacy and Safety Study of the Tolvaptan Tablets in Patients With Non-hypovolemic Non-acute Hyponatremia

PHASE2CompletedINTERVENTIONAL
Enrollment

241

Participants

Timeline

Start Date

May 31, 2008

Primary Completion Date

February 28, 2010

Study Completion Date

February 28, 2010

Conditions
Hypovolemic Hyponatremia
Interventions
DRUG

Tolvaptan

Tablet;15mg/tab;15/30/60mg/day for 7days Plus conventional therapy according to each patient's underlying disease, such as congestive heart failure, hepatic cirrhosis and SIADH or others.

DRUG

Placebo

placebo plus conventional therapy according to each patient's underlying disease, such as congestive heart failure, hepatic cirrhosis and SIADH or others.

Trial Locations (13)

Unknown

Department of Cardiology, the Third Xiangya Hospital, Central South University, Changsha

Department of Cardiology, Xiangya Hospital, Central South University, Changsha

Cardiology, Jilin University Second Hospital, Changchun

Endocrinology, West China Hospital Sichuan University, Chengdu

Cardiology / Endocrinology, Peking Union Medical College Hospital, Beijing

Cardiology / Hepatology, Beijing Friendship Hospital, Beijing

Cardiology/Endocrinology/Infection, Beijing University First Hospital, Beijing

Endocrinology, No. 301 hospital, Beijing

Hepatology, Beijing Renmin Hospital, Beijing

Hepatology/Endocrinology, Chongqing Medical University Second Hospital, Chongqing

Hepatology / Endocrinology, Shanghai Changzheng Hospital, Shanghai

Cardiology, Tianjin Medical University Second Hospital, Tianjin

Endocrinology, Tianjin General Hospital, Tianjin

All Listed Sponsors
collaborator

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

lead

Otsuka Beijing Research Institute

INDUSTRY