Pharmacokinetics and Pharmacodynamics of MTR105 in Hypotensive Cardiac Surgery Patients

Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00482287
• Other study ID #: MTR-105-US-102
• Status: Withdrawn
• Phase: Phase 2
• First received: June 1, 2007
• Last updated: April 6, 2015
• Start date: January 2008
• Est. completion date: June 2008

Study information

• Verified date: April 2015
• Source: Meditor Pharmaceuticals Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men or women age 18 years or older

• Referred for cardiac surgery requiring the use of CPB.

• Elective or urgent surgeries (non emergency operations).

• LVEF =40 based on cardiac catheterization results

• Normal renal function at study entry

• Normal hepatic function (within normal laboratory ranges) at study entry

• Normal coagulation status at study entry as judged by PT, PTT, fibrinogen and platelet count.

• Willingness to participate in the study and adhere to the study design.

• Willingness to sign an informed consent form.

Exclusion Criteria:

• Emergency operation

• Pulmonary hypertension (PA systolic pressure >60 mmHg)

• Ejection fraction less than 35% during weaning from bypass or cardiac index of less than 1.8

• Neurological events such as prior CVA, TIA or symptomatic carotid stenosis within 1 year of presenting for surgery

• Body weight <40 Kg

• Pregnancy

• Malignancy within 1 year of presenting for surgery

• Systemic infection as evidenced by elevated WBC or fever >38.5 C

• Usage of vasoactive medications within 24 hours except short term use of a vasoconstrictor during induction.

• Participation in any other investigational drug or device study within 30 days of randomization

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiopulmonary Bypass
• Hypotension

Intervention

Drug:
• MTR105
Intravenous administration, dose escalating (4 arms), single dose

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Meditor Pharmaceuticals Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemodynamic parameters		24 hours	No
Secondary	Pharmacokinetics		10 hours	No