A long-term administration study of OPC-41061 in patients with autosomal dominant polycystic kidney disease (ADPKD) [Extension of study 156-04-001]

Otsuka Pharmaceutical Co., Ltd.0 个研究点目标入组 17 人开始时间: 2009年2月2日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1) Patients who completed 5-day repeated administration and the follow-up observation in the preceding study (156-04-001)
•2) Patients in whom the safety of repeated administration was confirmed based on the investigator's reports from the preceding study (156-04-001)

•1) Patients with serum creatinine concentration of 2.5 mg/dL or higher at the screening examination
•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 disease
•4) Patients with SBP (in sitting position) <90 mm Hg (at screening examination)
•5) Patients with 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 women, lactating women, or women who may become or plan 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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