Tolvaptan Phase 3 Efficacy and Safety Study in ADPKD (TEMPO3/4)
This study's purpose is to evaluate the long-term safety and efficacy of tolvaptan versus placebo in patients with ADPKD.
Polycystic Kidney Disease, Autosomal Dominant
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablets Regimens in Adult Subjects With Autosomal Dominant Polycystic Kidney Disease|
- Rate of total kidney volume change(%) [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Time to onset of multiple ADPKD outcomes [ Time Frame: 36 months ] [ Designated as safety issue: No ]ADPKD outcomes include new onset hypertension, worsening hypertension, renal pain, worsening albuminuria and worsening renal function
- Evaluate long-term efficacy of tolvaptan in ADPKD using single clinical 4-markers of ADPKD progression [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Evaluate long-term safety of tolvaptan through standard clinical measures. [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
- Evaluate pharmacokinetic (PK), pharmacodynamic (PD) and exploratory parameters for tolvaptan in ADPKD. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2007|
|Study Completion Date:||January 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
oral tablet split-dose regimens (45/15mg, 60/30 mg or 90/30 mg) by mouth twice a day on awakening and approximately 9 hours later for 36 months. Daily dose regimen based on maximally tolerated dose.
Other Name: OPC-41061 or OPC-156
|Placebo Comparator: Placebo||
oral tablet split-dose regimens (45/15mg Placebo, 60/30 mg Placebo or 90/30 mg Placebo) by mouth twice a day on awakening and approximately 9 hours later for 36 months. Daily dose regimen based on maximally tolerated dose.
The current study will evaluate whether tolvaptan will be potentially beneficial, while maintaining an adequate safety profile, by reducing the rate of total renal volume increase, while impacting the onset, severity and progression of other important consequences of ADPKD.
Show 133 Study Locations
|Principal Investigator:||Vicente Torres, MD, PhD||Mayo Medical Center|
|Study Director:||Frank Czerwiec, MD, PhD||Otsuka Pharmaceutical Development and Commercialization, Inc.|
|Study Director:||Osamu Sato||Otsuka Pharmaceutical Corporation, Ltd. Japan|