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

February 9, 2009
April 7, 2011
April 2006
November 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00841568 on ClinicalTrials.gov Archive Site
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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]
A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Study 156-04-001]

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).

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).

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Autosomal Dominant Polycystic Kidney Disease
Drug: OPC-41061
orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years.
Experimental: 1
Intervention: Drug: OPC-41061
Higashihara E, Torres VE, Chapman AB, Grantham JJ, Bae K, Watnick TJ, Horie S, Nutahara K, Ouyang J, Krasa HB, Czerwiec FS; TEMPOFormula and 156-05-002 Study Investigators. Tolvaptan in autosomal dominant polycystic kidney disease: three years' experience. Clin J Am Soc Nephrol. 2011 Oct;6(10):2499-507. Epub 2011 Sep 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
November 2010
November 2010   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00841568
156-05-002, JapicCTI-090690
No
Kyoji Imaoka, Operating Officer, Director, Department of Clinical Research and Development, Otsuka Pharmaceutical Co., Ltd.
Otsuka Pharmaceutical Co., Ltd.
Not Provided
Not Provided
Otsuka Pharmaceutical Co., Ltd.
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP