NCT00482287

Pharmacokinetics and Pharmacodynamics of MTR105 in Hypotensive Cardiac Surgery Patients

A Phase II, Randomized, Double Blind, Placebo-controlled, Dose-escalating Study to Assess the Pharmacokinetics and Pharmacodynamics of MTR105 in Cardiac Surgery Induced Hypotension Patients During Weaning Off Cardiopulmonary Bypass

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Meditor Pharmaceuticals Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, pharmacokinetic and the pharmacodynamic effects of escalating doses of MTR105 while weaning from bypass in a hypotensive population of cardiac surgery patients.

Detailed description

The study is a prospective, randomized, four-arm, dose-escalating, double blind, placebo controlled study evaluating the safety, pharmacokinetics, and pharmacodynamics of four dose levels of MTR105 in patients undergoing cardiac surgery utilizing cardiopulmonary bypass presenting hypotension upon weaning off bypass.

Conditions

• Hypotension
• Cardiopulmonary Bypass

Interventions

Type	Name	Description
DRUG	MTR105	Intravenous administration, dose escalating (4 arms), single dose

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2007-06-05
• Last updated: 2015-04-07

Locations

1 site across 1 country: United States