Tolvaptan Open-label Pilot Efficacy, Tolerability, and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD) (TEMPO 2:4)
A Phase 2, Multi-center, Open-label Study to Determine Long-term Safety, Tolerability and Efficacy of Split-dose Oral Regimens of Tolvaptan Tablets in a Range of 30 to 120 mg/d in Patients With Autosomal Dominant Polycystic Kidney Disease
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Listed as NCT00413777, this PHASE2 trial focuses on Polycystic Kidney, Autosomal Dominant and remains completed. Sponsored by Otsuka Pharmaceutical Co., Ltd., it has been updated 7 times since 2005, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Status Flow
Change History
7 versions recorded-
Sep 2024 — Present [monthly]
Completed PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE2
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE2
-
Jun 2018 — Jan 2021 [monthly]
Completed PHASE2
-
Aug 2017 — Jun 2018 [monthly]
Completed PHASE2
▶ Show 2 earlier versions
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Feb 2017 — Aug 2017 [monthly]
Completed PHASE2
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Jan 2017 — Feb 2017 [monthly]
Completed PHASE2
First recorded
Dec 2005
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Otsuka Pharmaceutical Co., Ltd.
- Otsuka Pharmaceutical Development & Commercialization, Inc.
For direct contact, visit the study record on ClinicalTrials.gov .