Clinical trial
Tolvaptan Phase 3 Efficacy and Safety Study in Autosomal Dominant Polycystic…
NCT00428948 · Otsuka Pharmaceutical Development & Commercialization, Inc., Industry · Completed
Key facts
| NCT number | NCT00428948 |
|---|---|
| Title | Tolvaptan Phase 3 Efficacy and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD) |
| 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 |
| Acronym | TEMPO3:4 |
| Lead sponsor | Otsuka Pharmaceutical Development & Commercialization, Inc., Industry |
| Collaborators | Otsuka Pharmaceutical Co., Ltd. Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Polycystic Kidney Disease, Autosomal Dominant |
| Intervention type | Drug |
| Interventions | Tolvaptan, Placebo |
| Enrollment | 1,445 |
| Start date | Jan 1, 2007 |
| Primary completion | Jan 1, 2012 |
| Completion | Jan 1, 2012 |
| First posted | Jan 30, 2007 |
| Last update posted | Jul 2, 2017 |
| Countries | Argentina, Australia, Belgium, Canada, Denmark, France, Germany, Italy, Japan, Netherlands, Poland, Romania and 3 more |
At a glance
- 100–999 Study sites
- Yes Results posted
- 1–9 Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: