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 Pharmaceutical Co., Ltd.0 个研究点目标入组 15 人开始时间: 2009年11月13日最近更新: 2023年10月17日

适应症

试验速览

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•1) Patients who completed 3-year repeated administrations and the follow-up observation or those who were withdrawn from the study due to reasons other than occurrence of adverse events (based on the judgment of either the subject or the investigator/subinvestigator) in the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

•1) Patients with eGFR of less than 15 mL/min/1.73 m2
•2) Patients with any of the following complications
•- Uncontrolled hypertension
•- Serious cardiovascular disease (eg. heart failure) or hepatic disease (eg. cirrhosis)
•3) 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
•4) Patients with SBP (in sitting position) <90 mm Hg
•5) Patients with a history of massive bleeding or bleeding tendency
•6) Patients with a history of drug or alcohol abuse within 6 months prior to the screening examination
•7) Pregnant, breast-feeding, or possibly pregnant women or women who are planning to become pregnant
•8) Patients who received any investigational drug other than OPC-41061 within 30 days prior to commencement of administration of OPC-41061
•9) Any patient who, in the opinion of the principle investigator or subinvestigators, should not participate in the study

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