A long-term administration study of OPC-41061 in patients with autosomal dominant polycystic kidney disease (ADPKD) [Extension of study 156-04-001]
- Conditions
- Autosomal dominant polycystic kidney disease (ADPKD)
- Registration Number
- JPRN-jRCT2080220665
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 17
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety<br>156 weeks: adverse events, pre-treatment adverse events, laboratory values, plasma AVP concentration, vital signs, body weight, and ECG<br><br>Efficacy<br><br>156 weeks: combined renal volume (right and left kidneys) and renal function test<br>Pharmacology<br>156weeks: urine osmolality
- Secondary Outcome Measures
Name Time Method