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Pharmacokinetics and Pharmacodynamics of MTR105 in Hypotensive Cardiac Surgery Patients

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ClinicalTrials.gov Identifier: NCT00482287
Recruitment Status : Withdrawn (Site did not recruit any patients)
First Posted : June 5, 2007
Last Update Posted : April 7, 2015
Sponsor:
Information provided by:
Meditor Pharmaceuticals Ltd.

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.

Condition or disease Intervention/treatment Phase
Hypotension Cardiopulmonary Bypass Drug: MTR105 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : January 2008
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
1
Dose level 0.3 mg/kg with 6 active and 2 placebo
Drug: MTR105
Intravenous administration, dose escalating (4 arms), single dose

2
Dose level 0.6 mg/kg 6 patients active and 2 placebo
Drug: MTR105
Intravenous administration, dose escalating (4 arms), single dose

3
Dose level 1.2 mg/kg 6 active and 2 placebo
Drug: MTR105
Intravenous administration, dose escalating (4 arms), single dose

4
Dose level 2.4 mg/kg 6 active and 2 placebo
Drug: MTR105
Intravenous administration, dose escalating (4 arms), single dose




Primary Outcome Measures :
  1. Hemodynamic parameters [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Pharmacokinetics [ Time Frame: 10 hours ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00482287


Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Meditor Pharmaceuticals Ltd.
Investigators
Principal Investigator: Penny Sappington, MD University of Pittsburgh

Responsible Party: Adrian Harel, Meditor Pharmaceuticals Ltd
ClinicalTrials.gov Identifier: NCT00482287     History of Changes
Other Study ID Numbers: MTR-105-US-102
First Posted: June 5, 2007    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Hypotension
Vascular Diseases
Cardiovascular Diseases