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Trial record 43 of 112 for:    polycystic kidney disease

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:
ClinicalTrials.gov Identifier:
NCT00841568
First Posted: February 11, 2009
Last Update Posted: October 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Otsuka Pharmaceutical Co., Ltd.
  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:


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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

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


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
First Submitted: February 9, 2009
First Posted: February 11, 2009
Last Update Posted: October 18, 2017
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
Genetic Diseases, Inborn
Abnormalities, Multiple
Congenital Abnormalities
Tolvaptan
Antidiuretic Hormone Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs