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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Otsuka Pharmaceutical Co., Ltd.

ClinicalTrials.gov Identifier:

NCT01022424

First received: November 27, 2009

Last updated: April 23, 2012

Last verified: April 2012

History of Changes

Purpose

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.

Condition	Intervention	Phase
Autosomal Dominant Polycystic Kidney Disease	Drug: OPC-41061	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002]

Resource links provided by NLM:

Genetics Home Reference related topics: polycystic kidney disease

Drug Information available for: Tolvaptan

U.S. FDA Resources

Further study details as provided by Otsuka Pharmaceutical Co., Ltd.:

Primary Outcome Measures:

combined renal volume (right and left kidneys) and renal function test [ Time Frame: Every 12 or 48 weeks ] [ Designated as safety issue: No ]
adverse events [ Time Frame: Every 4, 12, or 24 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	15
Study Start Date:	November 2009
Estimated Study Completion Date:	November 2012
Estimated Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: OPC-41061 Repeated oral administration at doses of 15 mg twice daily (morning and evening)	Drug: OPC-41061 Repeated oral administration at doses of 15 mg twice daily (morning and evening)

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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Patients who completed 3-year repeated administrations and the follow-up observation or those who were withdrawn from the study due to reasons other than occurrence of adverse events (based on the judgment of either the subject or the investigator/subinvestigator) in the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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01022424

Locations

Japan

Kanto Region, Japan

Sponsors and Collaborators

Otsuka Pharmaceutical Co., Ltd.

More Information

No publications provided

Responsible Party:	Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:	NCT01022424 History of Changes
Other Study ID Numbers:	156-09-003, JapicCTI-090948
Study First Received:	November 27, 2009
Last Updated:	April 23, 2012
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Otsuka Pharmaceutical Co., Ltd.:

ADPKD
Tolvaptan
OPC-41061

Additional relevant MeSH terms:

Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Kidney Diseases, Cystic

ClinicalTrials.gov processed this record on May 21, 2013

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