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NCT00803634 · ClinicalTrials.gov registry record · Phase 3
Clevidipine in the Treatment of Blood Pressure in Patients With Acute Heart Failure (PRONTO)
A Phase 3 study, sponsored by The Medicines Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 117
- Enrollment target
NCT00803634: Completed Phase 3 study, sponsored by The Medicines Company.
NCT00803634 is a Phase 3 study that has completed, run by The Medicines Company. The registered enrollment target is 117 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00803634, a Phase 3 study, has completed, sponsored by The Medicines Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 117 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate the efficacy and safety of intravenous (IV) clevidipine as compared with standard of care IV antihypertensive agents for blood pressure (BP) lowering in patients with acute heart failure and elevated BP.
Primary Outcome
Time to first achieve the initial pre-specified systolic blood pressure (SBP) target range and a 15% SBP reduction from baseline is the time in minutes between the initiation of study medication and the time the patient first achieved both components. Median time was estimated using Kaplan Meier method. 95% two-sided confidence interval of the median time is from 'Simon and Lee, 1982'. If patients did not reach both components within 30 minutes from the initial treatment with study medication, o
Interventions
- DRUG Clevidipine
- DRUG Standard of Care IV antihypertensive
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 117 participants |
| Start Date | 2008-12 |
| Est. Completion | 2012-03 |
| Phase | Phase 3 |
What the finished NCT00803634 record still lists
NCT00803634 is an interventional study that assigns participants to a tested intervention. The registered 117 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Clevidipine is the first listed.
NCT00803634 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00803634 about?
NCT00803634 is a clinical study titled "Clevidipine in the Treatment of Blood Pressure in Patients With Acute Heart Failure (PRONTO)". The purpose of this study was to evaluate the efficacy and safety of intravenous (IV) clevidipine as compared with standard of care IV antihypertensive agents for blood pressure (BP) lowering in patients with acute heart failure and elevated BP.
What is the current status of trial NCT00803634?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 117 participants. The study started on 2008-12. Estimated completion is 2012-03.
What interventions are being tested in trial NCT00803634?
The interventions under investigation include: Clevidipine (DRUG), Standard of Care IV antihypertensive (DRUG).
Who is sponsoring clinical trial NCT00803634?
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 NCT00803634's enrollment target sits among peer trials
117 1642nd of 2000 higher than 358 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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