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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:
Otsuka Pharmaceutical Co., Ltd.
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
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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: | 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] |
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 ]
- Efficacy: combined renal volume (right and left kidneys) and renal function test [ Time Frame: 156 weeks ]
- Pharmacology: urine osmolality [ Time Frame: 156 weeks ]
| 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 |
| Sexes Eligible for Study: | All |
| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00841568
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):
| 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 |
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 21, 2017