CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 enrolled
Drug / intervention
MDCO-2010 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01535222
NCT01535222Phase 2Completed
CompareCT.gov

A Double-blind, Placebo-controlled, Randomized, Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MDCO-2010 in Patients Undergoing Elective CABG Surgery

The Medicines Company·interventional·Posted Feb 17, 2012·Updated Jul 19, 2012

In Brief

A Phase 2 clinical trial evaluating MDCO-2010 and Placebo for Coronary Artery Bypass Graft and Cardiopulmonary Bypass. Completed, enrolled 32 participants.

Detailed Summary

The purpose of this study is to demonstrate that periprocedural infusion of escalating doses of MDCO-2010 is safe and tolerated in patients undergoing elective CABG surgery, to characterize the single dose pharmacokinetics of MDCO-2010, to investigate the effect of MDCO-2010 on pharmacodynamics (biomarkers of fibrinolysis and coagulation parameters), and to investigate the effect on exploratory clinical endpoints of bleeding, transfusion requirements and reexploration.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Bypass Graft, Cardiopulmonary Bypass
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 17, 2012
Enrollment StartNov 1, 2010
Primary CompletionMay 1, 2011
Study CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 14.4 years ago

Interventions

MDCO-2010drug

MDCO-2010 solution for infusion. Dosage: Pump priming dose; Loading dose infusion over 6 minutes; Maintenance infusion for duration of surgery

Placebodrug

Commercially available NaCl