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This study has been withdrawn prior to enrollment.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
  Purpose

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 Intervention Phase
Hypotension
Cardiopulmonary Bypass
Drug: MTR105
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Meditor Pharmaceuticals Ltd.:

Primary Outcome Measures:
  • Hemodynamic parameters [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: 10 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: January 2008
Estimated Study Completion Date: June 2008
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Adrian Harel, Meditor Pharmaceuticals Ltd
ClinicalTrials.gov Identifier: NCT00482287     History of Changes
Other Study ID Numbers: MTR-105-US-102
Study First Received: June 1, 2007
Last Updated: December 9, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypotension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 02, 2014