A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Study 156-04-001]

Otsuka

Status and phase: Completed; Phase 2

Conditions: Autosomal Dominant Polycystic Kidney Disease

Treatments: Drug: OPC-41061

Study type: Interventional

Funder types: Industry

Identifiers

NCT00841568

156-05-002

JapicCTI-090690

Details and patient eligibility

About

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 (156-04-001).

Full 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 (156-04-001).

Enrollment: 17 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

1

Experimental group

Treatment:

Drug: OPC-41061