Pharmacokinetics and Pharmacodynamics of MTR105 in Hypotensive Cardiac Surgery Patients

Meditor Pharmaceuticals

Status and phase: Withdrawn; Phase 2

Conditions: Hypotension; Cardiopulmonary Bypass

Treatments: Drug: MTR105

Study type: Interventional

Funder types: Industry

Identifiers

NCT00482287

MTR-105-US-102

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 4 patient groups

1

Other group

Description:

Dose level 0.3 mg/kg with 6 active and 2 placebo

Treatment:

Drug: MTR105

2

Other group

Description:

Dose level 0.6 mg/kg 6 patients active and 2 placebo

Treatment:

Drug: MTR105

3

Other group

Description:

Dose level 1.2 mg/kg 6 active and 2 placebo

Treatment:

Drug: MTR105

4

Other group

Description:

Dose level 2.4 mg/kg 6 active and 2 placebo

Treatment:

Drug: MTR105