A Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Trial 156-04-251 in Japan]

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

ADPKD patients who enrolled in Trial 156-04-251 will receive repeated oral administration of tolvaptan twice daily (morning and evening: 45mg/15mg, 60mg/30mg, or 90mg/30mg).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.
• Treatments: Tolvaptan

Criteria

Inclusion Criteria:

• Patients who participated in Trial 156-04-251 in Japan and for whom CRF collection has been completed.

• Patients who completed 3-year repeated administration and who completed the second follow-up visit or patients whose treatment with the trial drug was interupted due to pregnancy and who completed out the second follow-up visit in Trial 156-04-251.

• Patients in whom any adverse events occurring in Trial 156-04-251 were resolved orstabilized and require no further follow-up.

Exclusion Criteria:

• Patients with eGFR of less than 15 mL/min/1.73 m2

• Pregnant, breast-feeding, or possibly pregnant women or women who are planning to become pregnant

• Patients who received any investigational drug other than Tolvaptan within 30 days prior to commencement of administration of tolvaptan

• Any patients who, in the opinion of the principle investigator or subinvestigators, should not participate in the study