Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00428948
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2007-01-26
Brief Title:
Tolvaptan Phase 3 Efficacy and Safety Study in Autosomal Dominant Polycystic Kidney Disease ADPKD
Sponsor:
Otsuka Pharmaceutical Development Commercialization Inc
Organization:
Otsuka Pharmaceutical Development Commercialization Inc
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TEMPO34
Brief Summary:
This studys purpose is to evaluate the long-term safety and efficacy of tolvaptan versus placebo in patients with ADPKD
Detailed Description:
This study evaluated whether or not tolvaptan is potentially beneficial while maintaining an adequate safety profile by reducing the rate of total kidney volume increase while impacting the onset severity and progression of other important consequences of ADPKD
During the 3-week titration phase tolvaptan or placebo was titrated in weekly intervals from lowest to highest tolerated levels given in split-dose regimens of 4515 mg 6030 mg and 9030 mg orally upon awakening and approximately 9 hours later As soon as a subject could not tolerate a given dose the titration phase was over and the maintenance phase began at the dose level tolerated The maintenance phase lasted to Month 36 Subjects were able to titrate down at any point during the study Subjects were able to titrate up during the maintenance phase with Medical Monitor approval
During the 3-week titration phase tolvaptan or placebo was titrated in weekly intervals from lowest to highest tolerated levels given in split-dose regimens of 4515 mg 6030 mg and 9030 mg orally upon awakening and approximately 9 hours later As soon as a subject could not tolerate a given dose the titration phase was over and the maintenance phase began at the dose level tolerated The maintenance phase lasted to Month 36 Subjects were able to titrate down at any point during the study Subjects were able to titrate up during the maintenance phase with Medical Monitor approval
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-002768-24 | EUDRACT_NUMBER | None | None |