Safety and Efficacy of CMX-2043 in Subjects Undergoing Co... | NCT00984802

Studies
Safety and Efficacy of CMX-2043 in Subjects Undergoing Coronary Reperfusion Therapy

NCT00984802

Sponsor

Ischemix, LLC

Status

Completed

Last Update Posted

Jun 20, 2011Estimated

Enrollment

142Actual

Phase

Phase 2

Conditions

Stable Coronary Artery Disease
Percutaneous Coronary Intervention

Interventions

CMX-2043
Placebo control

Countries

United States
India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2010

Primary Completion Date

Mar 2011Actual

Completion Date

Apr 2011Actual

First Submitted Date

Sep 23, 2009

First Submission Date that Met QC Criteria

Sep 24, 2009

First Posted Date

Sep 25, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 17, 2011

Last Update Posted Date

Jun 20, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is conducted to assess the safety of CMX-2043 solution for intravenous (IV) injection, and to evaluate efficacy on the basis of the changes seen in the cardiac biomarkers and continuous electrocardiography (ECG) monitoring. Additionally, correlation of the levels/changes in the biomarkers and the pharmacokinetic evaluations of the drug will be explored.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

142Actual

Label	Type	Intervention Names
Low dose	Experimental	Drug: CMX-2043
Mid Dose	Experimental	Drug: CMX-2043
High Dose	Experimental	Drug: CMX-2043
Placebo	Placebo Comparator	Drug: Placebo control

Name	Type	Description	Arm Group Labels	Other Names
CMX-2043	Drug	Solution for IV administration at 0.8, 1.6 or 2.4 mg/kg single dose.	High Dose Low dose Mid Dose

Measure	Description	Time Frame
Safety as measured by changes in CK-MB		within 24 hours

Measure	Description	Time Frame
Cardiac biomarkers		within 24 hours
ST segment changes		within 24 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects who have stable coronary artery disease undergoing elective PCI.
Female subjects not of child-bearing potential.
Absence of ST segment depression >1.0 mm and absence of ST elevation >1.0 mm in any lead on the baseline 12-lead ECG.
subjects with CK-MB and troponin-T levels lower than the upper limit of normal.
Subjects free of acute injuries or illnesses.

Exclusion Criteria:

Subjects with unstable angina (angina at rest, worsening frequency, duration of angina) or other signs of unstable coronary artery disease.
Subjects who had had an MI within 14 days prior to the PCI procedure.
Subjects with conditions that contraindicate the PCI (e.g. coagulopathy, valvular disease, PVD).
Subjects with history of TIA/stroke within 90 days or any intracranial bleed.
Subjects with creatinine clearance ≥ 1.5 times the upper limit of normal.
Subjects with an active history of psychiatric disorders that is likely to limit the validity of consent to participate in the study or limit the ability to comply with the protocol requirements.
Subjects with a history of alcohol or drug abuse.
Subjects with documented history of human immunodeficiency virus (HIV), or Hepatitis B (HBsAg) or Hepatitis C (HCV) virus positive.
Subjects with uncorrected clinically significant abnormalities of clinical laboratory tests who in the investigators opinion will interfere with the study conduct.
Subject with chronic diseases considered by the anesthetist unfit for surgery and/or who in the opinion of the investigator will increase the risk of the study or obscure the interpretation of results.
Subjects who have participated in a clinical study within 1 month or are currently participating in a clinical study of an investigational agent.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
St. Vincent Hospital		Worcester	Massachusetts	01608	United States
Duke University Hospital