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NCT00448864 · ClinicalTrials.gov registry record · Phase 2
Efficacy Study of Recombinant Protein (Ecallantide) to Reduce Blood Loss During Primary Coronary Bypass Grafting or Valve Repair/Replacement
A Phase 2 study, sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
- Terminated
- Registry status
- Phase 2
- Development phase
- 75
- Enrollment target
NCT00448864 is a Phase 2 study that was terminated before completion, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA). The registered enrollment target is 75 participants.
The verdict
NCT00448864, a Phase 2 study, was terminated before completion, sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 75 participants
- Enrollment target
Study Summary
The primary objective of this study was to assess the efficacy and safety of 2 dose levels of ecallantide versus placebo in reducing blood loss following cardiopulmonary bypass (CPB), as measured by chest tube drainage during the first 12 hours postoperatively or until the chest tube was removed, whichever came first, in patients undergoing primary coronary artery bypass grafting (CABG), single valve repair, or single valve replacement. The secondary objective was to compare the efficacy of all ecallantide-treated participants (pooled high and low-doses) to placebo and to compare the high-dose to the low-dose ecallantide group. Other secondary objectives were to evaluate pharmacokinetics and antibody formation.
Interventions
- DRUG Placebo
- DRUG Ecallantide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2007-05-01 |
| Est. Completion | 2008-08-01 |
| Phase | Phase 2 |
Sponsor
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)42 total trials
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00448864
The ClinicalTrials.gov registry entry for NCT00448864 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), which has 42 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00448864 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00448864 about?
NCT00448864 is a clinical study titled "Efficacy Study of Recombinant Protein (Ecallantide) to Reduce Blood Loss During Primary Coronary Bypass Grafting or Valve Repair/Replacement". The primary objective of this study was to assess the efficacy and safety of 2 dose levels of ecallantide versus placebo in reducing blood loss following cardiopulmonary bypass (CPB), as measured by chest tube drainage during the first 12 hours postoperatively or until the chest tube was removed, wh...
What is the current status of trial NCT00448864?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2007-05-01. Estimated completion is 2008-08-01.
What interventions are being tested in trial NCT00448864?
The interventions under investigation include: Placebo (DRUG), Ecallantide (DRUG).
Who is sponsoring clinical trial NCT00448864?
This trial is sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), which has 42 total clinical trials registered on ClinicalTrials.gov.
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