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

NCT ID: NCT01022424

Last Updated: 2018-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2014-07-31

Brief Summary

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.

Conditions

Autosomal Dominant Polycystic Kidney Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OPC-41061

Repeated oral administration at doses of 15 mg twice daily (morning and evening)

Group Type: EXPERIMENTAL

OPC-41061

Intervention Type: DRUG

Repeated oral administration at doses of 15 mg twice daily (morning and evening)

Interventions

OPC-41061

Repeated oral administration at doses of 15 mg twice daily (morning and evening)

Intervention Type: DRUG

Eligibility Criteria

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• Patients who completed 3-year repeated administrations and the follow-up observation or those who were withdrawn from the study due to reasons other than occurrence of adverse events (based on the judgment of either the subject or the investigator/subinvestigator) in the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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kanto Region, , Japan

Countries

Japan

Other Identifiers

JapicCTI-090948

Identifier Type: OTHER

Identifier Source: secondary_id

156-09-003

Identifier Type: -

Identifier Source: org_study_id