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

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:

Genetics Home Reference related topics: polycystic kidney disease

MedlinePlus related topics: Kidney Diseases

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


Ages Eligible for Study:	Child, Adult, Senior
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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. doi: 10.2215/CJN.03530411. Epub 2011 Sep 8.


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	Tolvaptan Antidiuretic Hormone Receptor Antagonists Molecular Mechanisms of Pharmacological Action Natriuretic Agents Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 23, 2016