HypotensionPhase 2NCT00482287
Pharmacokinetics and Pharmacodynamics of MTR105 in Hypotensive Cardiac Surgery Patients
A Phase 2 study testing MTR105 in people with Hypotension and Cardiopulmonary Bypass, run by Meditor Pharmaceuticals Ltd. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypotension, Cardiopulmonary Bypass
- What is being tested?
- MTR105
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jun 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
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
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.
Read the 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.
- Conditions
- Hypotension, Cardiopulmonary Bypass
- Being tested
- MTR105
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTR105Drug
Intravenous administration, dose escalating (4 arms), single dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Dose level 0.3 mg/kg with 6 active and 2 placebo Receives: Drug: MTR105 |
| 2 | Other | Dose level 0.6 mg/kg 6 patients active and 2 placebo Receives: Drug: MTR105 |
| 3 | Other | Dose level 1.2 mg/kg 6 active and 2 placebo Receives: Drug: MTR105 |
| 4 | Other | Dose level 2.4 mg/kg 6 active and 2 placebo Receives: Drug: MTR105 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic parameters
Measured: 24 hours
Secondary outcomes (1)
Pharmacokinetics
Measured: 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2007 (estimated)
- Study startJan 2008
- Primary completionJun 2008
- Study completionJun 2008
Why it stopped: Site did not recruit any patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meditor Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Penny Sappington, MD, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00482287
- Sponsor's protocol ID
- MTR-105-US-102
- Status last verified
- Apr 2015
- First submitted
- 1 Jun 2007
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00482287
- Acronym / sponsor ID
- MTR-105-US-102
- Conditions
- Hypotension, Cardiopulmonary Bypass
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Site did not recruit any patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Meditor Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 5 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: MTR105Dose level 0.3 mg/kg with 6 active and 2 placebo |
| 2 | Other | Drug: MTR105Dose level 0.6 mg/kg 6 patients active and 2 placebo |
| 3 | Other | Drug: MTR105Dose level 1.2 mg/kg 6 active and 2 placebo |
| 4 | Other | Drug: MTR105Dose level 2.4 mg/kg 6 active and 2 placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MTR105Intravenous administration, dose escalating (4 arms), single dose | Drug | 1, 2, 3, 4 |
Primary outcome
Hemodynamic parameters
Time frame: 24 hours
1 secondary outcome
Pharmacokinetics
Time frame: 10 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Penny Sappington, MD principal investigator
University of Pittsburgh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MTR105 in people with Hypotension and Cardiopulmonary Bypass, run by Meditor Pharmaceuticals Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemodynamic parameters (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015.