Efficacy and Safety of Tolvaptan in Cirrhotic Patients With Hyponatremia

CompletedOBSERVATIONAL
Enrollment

98

Participants

Timeline

Start Date

January 31, 2013

Primary Completion Date

September 30, 2014

Study Completion Date

May 31, 2015

Conditions
Liver CirrhosisHyponatremia
Interventions
DRUG

Tolvaptan

Tolvaptan (OPC-41061) is a benzazepine derivative synthesized by Otsuka Pharmaceutical Company, Ltd. Tolvaptan was approved for the treatment of specific forms of hyponatremia by the United States (US) Food and Drug Administration (FDA) in May 2009, the European Medicines Agency on Aug 2009, Japan (Oct 2010), China (Sep 2011) and Korea (Sep 2011). Tolvaptan was approved for the adjunct treatment of volume overload in heart failure by the Japanese Ministry of Health, Labour, and Welfare (MHLW) in Oct 2010. It is also being developed for the treatment of autosomal dominant polycystic kidney disease (ADPKD), and for the treatment of hepatic edema.

OTHER

conventional thearpy

conventional therapy with salt limitation ,et al

Trial Locations (19)

100018

Beijing Ditan Hospital, Beijing

100034

Peking University First Hospital, Beijing

100044

Peking University People's Hospital, Beijing

100050

Beijing Friendship Hospital, Capital Medical University, Beijing

100069

Beijing Youan Hospital, Beijing

200021

Shanghai Shuguang Hospital Affiliated with Shanghai University of Traditional Chinese Medicine, Shanghai

200032

Zhongshan Hospital Fudan University, Shanghai

200040

Shanghai Huashan Hospital, Shanghai

200052

85 Militay Hospital, Shanghai

200092

Shanghai Xinhua Hospital, Shanghai

200127

Shanghai Renji Hospital, Beijing

200333

Shanghai Putuo District Central Hospital, Shanghai

200433

Shanghai Changhai Hospital, Shanghai

201052

Shanghai Public Health Clinical Center, Shanghai

510630

The Third Affiliated Hospital of Sun Yat-sen University, Guangdong

Unknown

302 Military Hospital Integrative Medicine, Beijing

302 Military Hospital Liver Failure Center, Beijing

Guangdong General Hospital, Guangdong

Zhujiang Hospital of Southern Medical University, Guangdong

All Listed Sponsors
collaborator

Chinese University of Hong Kong

OTHER

lead

Beijing Friendship Hospital

OTHER

NCT01850940 - Efficacy and Safety of Tolvaptan in Cirrhotic Patients With Hyponatremia | Biotech Hunter | Biotech Hunter