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NCT01587040 · ClinicalTrials.gov registry record · Phase 1
Open Label Treatment Extension Study With SAR245408 or SAR245409 as a Monotherapy or as a Combination Regimen
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 61
- Enrollment target
NCT01587040: Completed Phase 1 study, sponsored by Sanofi.
NCT01587040 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 61 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01587040, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 61 participants
- Enrollment target
Study Summary
Primary Objective: The purpose of this study was to determine the long term safety and tolerability of SAR245408 and SAR245409 as a monotherapy or as part of a combination regimen in participants who were benefiting from treatment.
Primary Outcome
Any untoward medical occurrence in a participant who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. Serious adverse event (SAE): any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial/prolonged in-patient hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect/considered as medically important event. TEAEs: AEs that developed/worse
Interventions
- DRUG SAR245409
- DRUG SAR245408
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2012-07-20 |
| Est. Completion | 2018-05-23 |
| Phase | Phase 1 |
What the finished NCT01587040 record still lists
NCT01587040 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which SAR245409 is the first listed.
NCT01587040 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01587040 about?
NCT01587040 is a clinical study titled "Open Label Treatment Extension Study With SAR245408 or SAR245409 as a Monotherapy or as a Combination Regimen". Primary Objective: The purpose of this study was to determine the long term safety and tolerability of SAR245408 and SAR245409 as a monotherapy or as part of a combination regimen in participants who were benefiting from treatment.
What is the current status of trial NCT01587040?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 61 participants. The study started on 2012-07-20. Estimated completion is 2018-05-23.
What interventions are being tested in trial NCT01587040?
The interventions under investigation include: SAR245409 (DRUG), SAR245408 (DRUG).
Who is sponsoring clinical trial NCT01587040?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01587040's enrollment target sits among peer trials
61 828th of 2000 higher than 1,170 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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