drugset / Trial / NCT01210560
Dose-finding Study of New Tolvaptan Formulation in Subjects With ADPKD
RandomizedCrossoverQuadruple-blindTreatment
Summary
To establish pharmacokinetics (PK), pharmacodynamics (PD), and adverse event (AE) profile of tolvaptan administered as the modified-release (MR) formulation in ADPKD subjects. The goals of this trial are two-fold: 1. To directly compare the immediate release (IR) and MR formulations 2. To determine the dose range and dose regimen for MR (dose finding)
Timeline
- Start
- 2010-10
- Primary completion
- 2011-06
- Completion
- 2011-06
Publications
- St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.
- Gobburu J, Ivaturi V, Wang X, Shoaf SE, Jadhav P, Perrone RD. Comparing Effects of Tolvaptan and Instruction to Increase Water Consumption in ADPKD: Post Hoc Analysis of TEMPO 3:4. Kidney360. 2023 Dec 1;4(12):1702-1707. doi: 10.34067/KID.0000000000000302. Epub 2023 Nov 21.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tolvaptan | Unknown | 20 mg | Oral |
| Subject | Tolvaptan | Unknown | 40 mg | Oral |
| Subject | Tolvaptan | Unknown | 60 mg | Oral |
| Subject | Tolvaptan | Unknown | 120 mg | Oral |
| Subject | Tolvaptan | Unknown | 120 mg | — |