Tolvaptan Extension Study in Participants With ADPKD (TEMPO 4/4)
Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
This PHASE3 trial investigates Autosomal Dominant Polycystic Kidney Disease (ADPKD) and is currently completed. Otsuka Pharmaceutical Development & Commercialization, Inc. leads this study, which shows 9 recorded versions since 2010 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Status Flow
Change History
9 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE3
-
Sep 2024 — Sep 2025 [monthly]
Completed PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
-
Dec 2021 — Jul 2024 [monthly]
Completed PHASE3
-
Nov 2021 — Dec 2021 [monthly]
Completed PHASE3
▶ Show 4 earlier versions
-
Jan 2021 — Nov 2021 [monthly]
Completed PHASE3
-
Jun 2018 — Jan 2021 [monthly]
Completed PHASE3
-
Feb 2017 — Jun 2018 [monthly]
Completed PHASE3
-
Jan 2017 — Feb 2017 [monthly]
Completed PHASE3
First recorded
May 2010
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Otsuka Pharmaceutical Development & Commercialization, Inc.
For direct contact, visit the study record on ClinicalTrials.gov .