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

This study has been completed.
Sponsor:
Information provided by:
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00841568
First received: February 9, 2009
Last updated: April 7, 2011
Last verified: April 2011
History of Changes
  Purpose

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).


Condition Intervention Phase
Autosomal Dominant Polycystic Kidney Disease
 Drug: OPC-41061
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Study 156-04-001]

Resource links provided by NLM:

Drug Information available for: Tolvaptan
U.S. FDA Resources

Further study details as provided by Otsuka Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Safety: adverse events, laboratory values, plasma AVP concentration, vital signs, body weight, and ECG [ Time Frame: 156 weeks ] [ Designated as safety issue: Yes ]
  • Efficacy: combined renal volume (right and left kidneys) and renal function test [ Time Frame: 156 weeks ] [ Designated as safety issue: No ]
  • Pharmacology: urine osmolality [ Time Frame: 156 weeks ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: April 2006
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: OPC-41061
orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years.

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 (156-04-001).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00841568

Locations
Japan
Kanto Region, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
  More Information

No publications provided by Otsuka Pharmaceutical Co., Ltd.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Kyoji Imaoka, Operating Officer, Director, Department of Clinical Research and Development, Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00841568     History of Changes
Other Study ID Numbers: 156-05-002, JapicCTI-090690
Study First Received: February 9, 2009
Last Updated: April 7, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Otsuka Pharmaceutical Co., Ltd.:
ADPKD
Tolvaptan

Additional relevant MeSH terms:
Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Kidney Diseases, Cystic

ClinicalTrials.gov processed this record on May 16, 2013