Status:
COMPLETED
A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Study 156-04-001]
Lead Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Conditions:
Autosomal Dominant Polycystic Kidney Disease
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
Investigation into the long-term safety and efficacy of OPC-41061 in repeated oral administrations at doses of 15 mg twice daily in patients with ADPKD who completed the preceding dose-finding study (...
Detailed Description
Investigation into the long-term safety and efficacy of OPC-41061 in repeated oral administrations at doses of 15 mg twice daily in patients with ADPKD who completed the preceding dose-finding study (...
Eligibility Criteria
Inclusion
- Patients who completed 5-day repeated administrations and the follow-up observation in the preceding study (156-04-001)
- Patients in whom the safety of repeated administration was confirmed based on the investigator's reports from the preceding study (156-04-001)
Exclusion
- Patients with serum creatinine concentration of 2.5 mg/dL or higher at the screening examination
- 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 thereto)
- Inability to personally give consent due to a mental disease "
- Patients with SBP (in sitting position) \<90 mm Hg (at screening examination)
- Patients with history of massive bleeding or bleeding tendency
- Patients with a history of drug or alcohol abuse within 6 months prior to the screening examination
- Pregnant women, lactating women, or women who may become or plan to become pregnant
- Patients who received any investigational drug other than OPC-41061 within 30 days prior to commencement of administration of OPC-41061
- Any patient who, in the opinion of the principle investigator or attending investigators, should not participate in the study
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00841568
Start Date
April 1 2006
End Date
November 1 2010
Last Update
September 11 2018
Active Locations (1)
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1
Kanto Region, Japan