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

Tracking Information
First Received Date ^ICMJE	February 9, 2009
Last Updated Date	April 7, 2011
Start Date ^ICMJE	April 2006
Primary Completion Date	November 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 10, 2009)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00841568 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Study 156-04-001]
Official Title ^ICMJE	A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Study 156-04-001]
Brief Summary	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).
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).
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Autosomal Dominant Polycystic Kidney Disease
Intervention ^ICMJE	Drug: OPC-41061 orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years.
Study Arm (s)	Experimental: 1 Intervention: Drug: OPC-41061
Publications *	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.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	17
Completion Date	November 2010
Primary Completion Date	November 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Japan

Administrative Information
NCT Number ^ICMJE	NCT00841568
Other Study ID Numbers ^ICMJE	156-05-002, JapicCTI-090690
Has Data Monitoring Committee	No
Responsible Party	Kyoji Imaoka, Operating Officer, Director, Department of Clinical Research and Development, Otsuka Pharmaceutical Co., Ltd.
Study Sponsor ^ICMJE	Otsuka Pharmaceutical Co., Ltd.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Otsuka Pharmaceutical Co., Ltd.
Verification Date	April 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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