A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002]

Otsuka

Status and phase

Completed

Phase 3

Conditions

Autosomal Dominant Polycystic Kidney Disease

Treatments

Drug: OPC-41061

Study type

Interventional

Funder types

Industry

Identifiers

NCT01022424

JapicCTI-090948 (Other Identifier)

156-09-003

Details and patient eligibility

About

ADPKD patients who were enrolled in Study 156-05-002 will receive repeated oral administration of OPC-41061 at doses of 15 mg twice daily (morning and evening). Administration will be continued until the time of manufacturing and distribution approval of OPC-41061 for ADPKD in Japan.

Enrollment

13 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients who completed 3-year repeated administrations and the follow-up observation or those who were withdrawn from the study due to reasons other than occurrence of adverse events (based on the judgment of either the subject or the investigator/subinvestigator) in the preceding study (156-05-002)
Patients in whom adverse events occurring in study 156-05-002 were resolved or became stable and do not require further follow-up.

Exclusion criteria

Patients with eGFR of less than 15 mL/min/1.73 m2
Patients with any of the following complications:
- Uncontrolled hypertension
- Serious cardiovascular disease (eg. heart failure) or hepatic disease (eg. cirrhosis)
Patients with any of the following complications or history thereof:
- Clinically significant drug allergies (anaphylaxis) or hypersensitivity (especially, hypersensitivity to benzazepine derivatives or suspected hypersensitivity
- Inability to personally give consent due to a mental illness