- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00156780
Phase 1 Safety and Pharmacokinetic Study of AI-700 in Patients With Diminished DLCO and COPD and/or CHF
October 19, 2006 updated by: Acusphere
A Phase 1, Double Blind, Crossover, Placebo-Controlled, Dual-Injection, Safety and Pharmacokinetic Study of AI-700 in Patients With Diminished DLCO and Chronic Obstructive Pulmonary Disease (COPD) and/or Congestive Heart Failure (CHF)
This study was conducted to evaluate the safety and pharmacokinetics of an echocardiographic contrast agent, AI-700, in patients with moderate to severe chronic obstructive pulmonary disease (COPD) and/or congestive heart failure (CHF).
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
In ongoing clinical trials, AI-700 is currently being evaluated for its value to provide enhanced echocardiography to detect CAD.
The patient population is comprised of those patients who have chest pain and are being evaluated for inducible ischemia.
This population may include patients with compromised pulmonary function due to COPD or CHF.
This study was to evaluate the safety of AI-700 in these patients.
Study Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Watertown, Massachusetts, United States, 02472
- Acusphere, Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Educational/Counseling/Training
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
To determine the safety of AI-700 in patients with diminished pulmonary diffusing capacity (DLCO) and moderate or severe COPD and/or CHF
|
To determine the pharmacokinetics of perfluorocarbon gas in blood following an intravenous injection of AI-700 in this patient population
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2004
Study Completion
July 1, 2005
Study Registration Dates
First Submitted
September 8, 2005
First Submitted That Met QC Criteria
September 8, 2005
First Posted (Estimate)
September 12, 2005
Study Record Updates
Last Update Posted (Estimate)
October 23, 2006
Last Update Submitted That Met QC Criteria
October 19, 2006
Last Verified
July 1, 2006
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AI-700-05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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