Pharmacokinetics and Pharmacodynamics of MTR105 in Hypotensive Cardiac Surgery Patients

This study has been withdrawn prior to enrollment.
(Site did not recruit any patients)
Sponsor:
Information provided by:
Meditor Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier:
NCT00482287
First received: June 1, 2007
Last updated: December 9, 2008
Last verified: December 2008

June 1, 2007
December 9, 2008
January 2008
June 2008   (final data collection date for primary outcome measure)
Hemodynamic parameters [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Hemodynamic parameters [ Time Frame: 24 hours ]
Complete list of historical versions of study NCT00482287 on ClinicalTrials.gov Archive Site
Pharmacokinetics [ Time Frame: 10 hours ] [ Designated as safety issue: No ]
Pharmacokinetics [ Time Frame: 10 hours ]
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Hypotension
  • Cardiopulmonary Bypass
Drug: MTR105
Intravenous administration, dose escalating (4 arms), single dose
  • 1
    Dose level 0.3 mg/kg with 6 active and 2 placebo
    Intervention: Drug: MTR105
  • 2
    Dose level 0.6 mg/kg 6 patients active and 2 placebo
    Intervention: Drug: MTR105
  • 3
    Dose level 1.2 mg/kg 6 active and 2 placebo
    Intervention: Drug: MTR105
  • 4
    Dose level 2.4 mg/kg 6 active and 2 placebo
    Intervention: Drug: MTR105
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
36
June 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00482287
MTR-105-US-102
No
Adrian Harel, Meditor Pharmaceuticals Ltd
Meditor Pharmaceuticals Ltd.
Not Provided
Principal Investigator: Penny Sappington, MD University of Pittsburgh
Meditor Pharmaceuticals Ltd.
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP