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NCT01826266 · ClinicalTrials.gov registry record · Phase 1
Effects of a Double-Blind, Single Dose of PER977 Administered Alone, and Following a Single Dose of Edoxaban
A Phase 1 study, sponsored by Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 83
- Enrollment target
NCT01826266: Completed Phase 1 study, sponsored by Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals.
NCT01826266 is a Phase 1 study that has completed, run by Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals. The registered enrollment target is 83 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01826266, a Phase 1 study, has completed, sponsored by Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 83 participants
- Enrollment target
Study Summary
PER977 monotherapy and co-administration following 60 mg edoxaban will have an acceptable safety and tolerability profile with no impact on pro-coagulant biomarkers. A dose of PER977 that reverses the effects of edoxaban on the pharmacodynamic (PD) biomarkers (point of care prothrombin time \[PoC-PT\]), and/or secondary biomarkers (thromboelastography reaction time \[TEG-R\]) will be identified.
Interventions
- DRUG PER977, Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2013-07 |
| Est. Completion | 2013-12 |
| Phase | Phase 1 |
Sponsor
Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals9 total trials
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01826266
The ClinicalTrials.gov registry entry for NCT01826266 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 83 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which PER977, Placebo is the first listed.
NCT01826266 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01826266 about?
NCT01826266 is a clinical study titled "Effects of a Double-Blind, Single Dose of PER977 Administered Alone, and Following a Single Dose of Edoxaban". PER977 monotherapy and co-administration following 60 mg edoxaban will have an acceptable safety and tolerability profile with no impact on pro-coagulant biomarkers. A dose of PER977 that reverses the effects of edoxaban on the pharmacodynamic (PD) biomarkers (point of care prothrombin time \[PoC-PT...
What is the current status of trial NCT01826266?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 83 participants. The study started on 2013-07. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01826266?
The interventions under investigation include: PER977, Placebo (DRUG).
Who is sponsoring clinical trial NCT01826266?
This trial is sponsored by Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, which has 9 total clinical trials registered on ClinicalTrials.gov.
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