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A Dose-ranging Safety and Efficacy Study of Ecallantide to Reduce Surgical Blood Loss Volume

NCT00816023 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2015-08-11

Study results available
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Summary

The purpose of this study is to assess the efficacy and identify the optimal dose(s) of ecallantide in reducing blood loss in subjects undergoing coronary artery bypass surgery including the use of cardio pulmonary bypass.

Conditions

  • Bloodloss
  • Surgical Procedures, Operative

Interventions

DRUG

ecallantide

infusion administered IV over the duration of the surgical procedure

DRUG

placebo

solution for IV infusion over the duration of the surgical\>\> procedure

Sponsors & Collaborators

  • Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

    lead INDUSTRY

Principal Investigators

  • Alistair Wheeler, MD, MFPM · Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2009-12-31
Completion
2010-01-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00816023 on ClinicalTrials.gov