AzTrials
AzTrials

HealthyPhase 2NCT00584818

Dose Finding Study of PB127 Ultrasound Contrast Agent in Healthy Volunteers and Patients With Coronary Artery Disease

A Phase 2 study testing PB127 for Injectable Suspension in people with Healthy and Coronary Artery Disease, run by Point Biomedical at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to determine the dose of PB127 for detection and/or exclusion of coronary artery disease when used with cardiac ultrasound. This study also evaluates the safety of PB127. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy, Coronary Artery Disease
What is being tested?
PB127 for Injectable Suspension
Type of treatment
Injection or infusion
How many people
205 participants
Where
16 sitesUnited States
Study dates
Nov 2006to Mar 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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Stages 1 and 2
  • Men and women
  • Ages 18 30
  • Normal volunteers
  • No history (or suspicion) of CAD
  • Stage 3
Show all 12Show fewer
  • Men and women with known or suspected CAD
  • Ages 18 years and older
  • Scheduled for or undergone clinically indicated coronary angiography within 28 days prior to or following Study Day 1
  • Coronary angiography within 28 days prior to Study Day 1 and/or SPECT must have been non-interventional
  • Coronary angiography images available in digital format (non cine) for transmission to core laboratory
  • Scheduled for or undergone SPECT within 28 days prior to or following Study Day 1

Who cannot join

  • Unable to provide written informed consent
  • Women who are pregnant or lactating
  • Known hypersensitivity or known contraindication to:
  • Dipyridamole
  • Ultrasound contrast agents (including PB127 and excipients)
  • Blood, blood products, albumin, egg whites, or protein
Show all 29Show fewer
  • Use of caffeine or xanthine containing products within the 24 hours prior to PB127 administration on Study Day 1 (Stages 2 and 3)
  • Previous exposure to PB127
  • Inadequate echocardiographic windows
  • Heart transplant
  • Known right to left shunt, including atrial septal defect
  • History of CABG
  • Current uncontrolled ventricular tachycardia, atrial fibrillation, atrial tachycardia, or atrial flutter
  • Pacemaker or defibrillator
  • Unstable angina grade CCS Class IV severity with ongoing symptoms and/or ongoing infusion of IV nitroglycerin
  • Second degree or greater heart block
  • Hypertension (SPB >200 and/or DBP >110 mmHg on two consecutive readings within 1 hour prior to PB127 administration)
  • Hypotension (SPB <90 mmHg on two consecutive readings within 1 hour prior to PB127 administration)
  • Severe aortic stenosis (>100 mmHg peak transvalvar gradient or <0.6 cm2 estimated valve area)
  • Pulmonary edema within the 7 days prior to Study Day 1
  • Resting oxygen saturation of less than 90%
  • Q wave MI or major surgery within the 7 days prior to Study Day 1
  • PTCA within the 28 days prior to Study Day 1
  • Chronic obstructive pulmonary disease or bronchospastic airway disease which, in the opinion of the Investigator, is significant enough to contraindicate dipyridamole
  • Known history of severe pulmonary hypertension characterized by estimated pulmonary artery systolic pressure of >50 mmHg
  • Liver disease, characterized by or including one or more of the following
  • Elevated total bilirubin > upper limit of normal
  • Currently elevated hepatic enzymes >3X upper limit of normal
  • Medical conditions or other circumstances that would significantly decrease the chances of obtaining reliable data or achieving the study objectives (i.e., drug dependence, psychiatric disorder, dementia, or associated illness); extenuating circumstances or medical conditions that make it unlikely that a patient can complete the clinical trial or follow up evaluations; or other reasons for expected poor compliance with the clinical investigator's instructions

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • Androscoggin Cardiovascular Associates

    Auburn, Maine, 04210

  • Seton Healthcare Network Brackenridge Hospital

    Austin, Texas, 78701

  • Austin Heart

    Austin, Texas, 78705

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Cardiovascular Consultants

    Kansas City, Missouri, 64111

  • Long Beach VA Medical Center Cardiology Division

    Long Beach, California, 90822

  • Alfieri Cardiology

    Newark, Delaware, 19713

  • Midwest Cardiology Associates

    Overland Park, Kansas, 66209

  • University of Pittsburgh Cardiovascular Institute

    Pittsburgh, Pennsylvania, 15213

  • Oregon Health Sciences University

    Portland, Oregon, 97239

  • University of California San Diego Division of Cardiology

    San Diego, California, 92103

  • The Center for Cardiovascular Studies Kramer and Crouse Cardiology

    Shawnee Mission, Kansas, 66204

  • Inland Cardiology

    Spokane, Washington, 99204

  • Northwest Cardiovascular Research Institute Spokane Cardiology

    Spokane, Washington, 99204

  • St. Louis University Medical Center

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Phase 2 Dose-Finding Clinical Trial of CARDIOsphere® (PB127) in Normal Volunteers and in Patients With Known or Suspected Coronary Artery Disease

The purpose of this study is to determine the dose of PB127 for detection and/or exclusion of coronary artery disease when used with cardiac ultrasound. This study also evaluates the safety of PB127.

Being tested
PB127 for Injectable Suspension
Keywords
coronary artery disease, chest pain, healthy volunteers, SPECT, angiogram, ultrasound, echocardiogram, perfusion
Medical subject headings
Coronary Artery Disease, Chest Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PB127 for Injectable SuspensionDrug

    Also called CARDIOsphere®

    Stages 1 \& 2 0.009 - 0.204 mg/kg continuous IV during rest and stress conditions. Infusion rate of 50 - 125 mL/hr will be adjusted for image quality and diagnostic quality. Infusion limited to 60 minutes or less.

    Stage 3 - will utilize infusion rate and dose established in Stages 1 \& 2. 0.062 mg/kg continuous IV infusion at 150 mL/hr during rest and 100 mL/hr during stress conditions.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To identify the minimum effective dose of PB127

    Measured: 24 hours

  2. To identify the optimal stress infusion rate of PB127

    Measured: 24 hours

Secondary outcomes (2)

  1. To assess the efficacy of PB127 MPE using the dose and stress infusion rate identified in Stages 1 and 2

    Measured: 24 hours

  2. To evaluate the safety of PB127

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2008 (estimated)
  2. Study startNov 2006
  3. Primary completionMar 2008
  4. Study completionMar 2008

Resources

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
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
205 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00584818
Sponsor's protocol ID
127-013
Status last verified
Apr 2008
First submitted
20 Dec 2007
Last updated
25 Apr 2008
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PB127 for Injectable Suspension in people with Healthy and Coronary Artery Disease, run by Point Biomedical at 16 sites 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 12 inclusion and 29 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: finished, as of the sponsor's last update on 25 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To identify the minimum effective dose of PB127 (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00584818.

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 25 Apr 2008.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in