Clinical trial
Tolvaptan Open-label Pilot Efficacy, Tolerability, and Safety Study in Autosomal…
NCT00413777 · Otsuka Pharmaceutical Development & Commercialization, Inc., Industry · Completed
Key facts
| NCT number | NCT00413777 |
|---|---|
| Title | Tolvaptan Open-label Pilot Efficacy, Tolerability, and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD) |
| Official title | 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 |
| Acronym | TEMPO 2:4 |
| Lead sponsor | Otsuka Pharmaceutical Development & Commercialization, Inc., Industry |
| Collaborators | Otsuka Pharmaceutical Co., Ltd. Industry |
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Polycystic Kidney, Autosomal Dominant |
| Intervention type | Drug |
| Interventions | Tolvaptan |
| Enrollment | 46 |
| Start date | Dec 1, 2005 |
| Primary completion | Jun 1, 2010 |
| Completion | Jun 1, 2010 |
| First posted | Dec 20, 2006 |
| Last update posted | Jul 2, 2017 |
| Countries | United States |
At a glance
- 10–99 Study sites
- Yes Results posted
- None 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: