NCT01349335

Dose Exploring and Setting Study for Tolvaptan to Treat Hepatic Cirrhosis With Ascites

A Phase 2 Randomized, Double-blinded, Multicenter and Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of Different Doses of Tolvaptan Tablet in Patients With Cirrhotic Ascites

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Otsuka Beijing Research Institute · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To observe the safety/efficacy of tolvaptan for treatment of patients with hepatic cirrhosis with ascites and exploring the dosage-effect relations of the drug.

Detailed description

Tolvaptan is able to exert hydragogue diuretic effects (water diuresis) via inhibition of water reabsorption by renal collecting ducts without corresponding increase in electrolyte excretion. It has been confirmed that tolvaptan is able to increase urine volume without any adverse effects on renal functions.

Conditions

• Ascites
• Hepatic Cirrhosis

Interventions

Type	Name	Description
DRUG	Tolvaptan	tablet, 15 mg, Qd, for 7 days
DRUG	Tolvaptan	tablet, 30 mg, Qd, 7 days
DRUG	placebo	tablet, 30 mg, Qd, 7days.

Timeline

• Start date: 2009-04-01
• Primary completion: 2010-01-01
• Completion: 2010-04-01
• First posted: 2011-05-06
• Last updated: 2012-10-12

Locations

1 site across 1 country: China