A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Study 156-04-001]
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ClinicalTrials.gov Identifier: NCT00841568 |
Recruitment Status
:
Completed
First Posted
: February 11, 2009
Last Update Posted
: April 11, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Autosomal Dominant Polycystic Kidney Disease | Drug: OPC-41061 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 17 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (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] |
Study Start Date : | April 2006 |
Actual Primary Completion Date : | November 2010 |
Actual Study Completion Date : | November 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Drug: OPC-41061
orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years.
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- Safety: adverse events, laboratory values, plasma AVP concentration, vital signs, body weight, and ECG [ Time Frame: 156 weeks ]
- Efficacy: combined renal volume (right and left kidneys) and renal function test [ Time Frame: 156 weeks ]
- Pharmacology: urine osmolality [ Time Frame: 156 weeks ]

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)"
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00841568
Japan | |
Kanto Region, Japan |
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 |
First Posted: | February 11, 2009 Key Record Dates |
Last Update Posted: | April 11, 2011 |
Last Verified: | April 2011 |
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 Abnormalities, Multiple Congenital Abnormalities |
Genetic Diseases, Inborn Tolvaptan Antidiuretic Hormone Receptor Antagonists Molecular Mechanisms of Pharmacological Action Natriuretic Agents Physiological Effects of Drugs |