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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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01280721
First received: December 6, 2010
Last updated: June 12, 2013
Last verified: June 2013

December 6, 2010
June 12, 2013
November 2010
March 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Body weight [ Time Frame: Every month until 4 years from the date of initial trial drug administration to the first patient ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Plasma AVP concentration [ Time Frame: Every 12 months until 4 years from the date of initial trial drug administration to the first patient ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01280721 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.
 
Active, not recruiting
150
March 2014
March 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
Both
23 Years to 53 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01280721
156-10-003, JapicCTI-101362
No
Otsuka Pharmaceutical Co., Ltd.
Otsuka Pharmaceutical Co., Ltd.
Not Provided
Not Provided
Otsuka Pharmaceutical Co., Ltd.
June 2013

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