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A Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Trial 156-04-251 in Japan]

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01280721
First Posted: January 21, 2011
Last Update Posted: October 19, 2015
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 (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
December 6, 2010
January 21, 2011
October 19, 2015
November 2010
August 2014   (Final data collection date for primary outcome measure)
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Every month until 4 years from the date of initial trial drug administration to the first patient ]
  • Vital signs (systolic and diastolic blood pressure, pulse rate) [ Time Frame: Every month until 4 years from the date of initial trial drug administration to the first patient ]
  • Body weight [ Time Frame: Every month until 4 years from the date of initial trial drug administration to the first patient ]
  • Laboratory values (hematology, serum chemistry and urinalysis) [ Time Frame: Every 3 months until 4 years from the date of initial trial drug administration to the first patient ]
  • Plasma AVP concentration [ Time Frame: Every 12 months until 4 years from the date of initial trial drug administration to the first patient ]
  • 12-lead ECG (heart rate, PR interval, QRS interval and QT interval) [ Time Frame: Every 12 months until 4 years from the date of initial trial drug administration to the first patient ]
  • Combined renal volume (right and left kidneys) [ Time Frame: Every 12 months until 4 years from the date of initial trial drug administration to the first patient ]
  • Renal function (estimated GFR and serum cystatin C) [ Time Frame: Every 3 months until 4 years from the date of initial trial drug administration to the first patient ]
Same as current
Complete list of historical versions of study NCT01280721 on ClinicalTrials.gov Archive Site
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A Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Trial 156-04-251 in Japan]
A Multicenter, Open-label Extension Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Trial 156-04-251 in Japan]
ADPKD patients who enrolled in Trial 156-04-251 will receive repeated oral administration of tolvaptan twice daily (morning and evening: 45mg/15mg, 60mg/30mg, or 90mg/30mg).
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Drug: tolvaptan
Repeated oral administration twice daily (morning and evening) at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg.
Experimental: tolvaptan
Repeated oral administration twice daily (morning and evening) at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg.
Intervention: Drug: tolvaptan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
135
August 2014
August 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who participated in Trial 156-04-251 in Japan and for whom CRF collection has been completed.
  • Patients who completed 3-year repeated administration and who completed the second follow-up visit or patients whose treatment with the trial drug was interupted due to pregnancy and who completed out the second follow-up visit in Trial 156-04-251.
  • Patients in whom any adverse events occurring in Trial 156-04-251 were resolved orstabilized and require no further follow-up.

Exclusion Criteria:

  • Patients with eGFR of less than 15 mL/min/1.73 m2
  • Pregnant, breast-feeding, or possibly pregnant women or women who are planning to become pregnant
  • Patients who received any investigational drug other than Tolvaptan within 30 days prior to commencement of administration of tolvaptan
  • Any patients who, in the opinion of the principle investigator or subinvestigators, should not participate in the study
Sexes Eligible for Study: All
23 Years to 53 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01280721
156-10-003
JapicCTI-101362 ( Other Identifier: Japan Pharmaceutical Information Center )
No
Not Provided
Not Provided
Otsuka Pharmaceutical Co., Ltd.
Otsuka Pharmaceutical Co., Ltd.
Not Provided
Not Provided
Otsuka Pharmaceutical Co., Ltd.
October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP