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Pharmacokinetics and Pharmacodynamics of MTR105 in Hypotensive Cardiac Surgery Patients

Primary Purpose

Hypotension, Cardiopulmonary Bypass

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MTR105
Sponsored by
Meditor Pharmaceuticals Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypotension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Pittsburgh Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

1

2

3

4

Arm Description

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

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

Dose level 1.2 mg/kg 6 active and 2 placebo

Dose level 2.4 mg/kg 6 active and 2 placebo

Outcomes

Primary Outcome Measures

Hemodynamic parameters

Secondary Outcome Measures

Pharmacokinetics

Full Information

First Posted
June 1, 2007
Last Updated
April 6, 2015
Sponsor
Meditor Pharmaceuticals Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00482287
Brief Title
Pharmacokinetics and Pharmacodynamics of MTR105 in Hypotensive Cardiac Surgery Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Site did not recruit any patients
Study Start Date
January 2008 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Meditor Pharmaceuticals Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension, Cardiopulmonary Bypass

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
Dose level 0.3 mg/kg with 6 active and 2 placebo
Arm Title
2
Arm Type
Other
Arm Description
Dose level 0.6 mg/kg 6 patients active and 2 placebo
Arm Title
3
Arm Type
Other
Arm Description
Dose level 1.2 mg/kg 6 active and 2 placebo
Arm Title
4
Arm Type
Other
Arm Description
Dose level 2.4 mg/kg 6 active and 2 placebo
Intervention Type
Drug
Intervention Name(s)
MTR105
Intervention Description
Intravenous administration, dose escalating (4 arms), single dose
Primary Outcome Measure Information:
Title
Hemodynamic parameters
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Pharmacokinetics
Time Frame
10 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Penny Sappington, MD
Organizational Affiliation
University of Pittsburgh Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

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Pharmacokinetics and Pharmacodynamics of MTR105 in Hypotensive Cardiac Surgery Patients

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