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NCT00799604 · ClinicalTrials.gov registry record · Phase 2
Clevidipine Bolus Administration in the Treatment of Hypertensive Patients Undergoing Cardiac Surgery (SPRINT)
A Phase 2 study, sponsored by The Medicines Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT00799604: Completed Phase 2 study, sponsored by The Medicines Company.
NCT00799604 is a Phase 2 study that has completed, run by The Medicines Company. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00799604, a Phase 2 study, has completed, sponsored by The Medicines Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
This study was designed to evaluate the pharmacodynamics of a bolus dosing regimen of clevidipine, a vascular-selective L-type calcium channel antagonist, for the management of blood pressure in cardiac surgery patients, as well as to evaluate the efficacy, safety and pharmacokinetics of clevidipine after bolus administration.
Primary Outcome
Blood Pressure was measured at 60, 45, 30, 0 seconds prior to first Bolus dose (Bolus 1), and every 5 seconds after Bolus 1 for 15 minutes. Baseline SBP of Bolus 1 is defined as, 'median of all measurements prior to or at the start of Bolus 1'. Locally weighted scatterplot smoothing (LOWESS) method was used to determine the minimum SBP value for each patient. Maximum absolute change is the minimum SBP value within 15 minutes from bolus 1 minus baseline value.
Interventions
- DRUG clevidipine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2008-11 |
| Est. Completion | 2009-10 |
| Phase | Phase 2 |
What the finished NCT00799604 record still lists
NCT00799604 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which clevidipine is the first listed.
NCT00799604 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00799604 about?
NCT00799604 is a clinical study titled "Clevidipine Bolus Administration in the Treatment of Hypertensive Patients Undergoing Cardiac Surgery (SPRINT)". This study was designed to evaluate the pharmacodynamics of a bolus dosing regimen of clevidipine, a vascular-selective L-type calcium channel antagonist, for the management of blood pressure in cardiac surgery patients, as well as to evaluate the efficacy, safety and pharmacokinetics of clevidipine...
What is the current status of trial NCT00799604?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2008-11. Estimated completion is 2009-10.
What interventions are being tested in trial NCT00799604?
The interventions under investigation include: clevidipine (DRUG).
Who is sponsoring clinical trial NCT00799604?
This trial is sponsored by The Medicines Company, which has 35 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00799604's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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