A Prospective, Phase IV, Surveillance Registry Study to Evaluate the Safety of DEFINITY® in Clinical Practice
This study has been completed.
Sponsor:
Lantheus Medical Imaging
Information provided by (Responsible Party):
Lantheus Medical Imaging
ClinicalTrials.gov Identifier:
NCT00625365
First received: February 20, 2008
Last updated: October 14, 2011
Last verified: August 2011
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Results First Received: December 17, 2010
| Study Type: | Interventional |
|---|---|
| Study Design: | Endpoint Classification: Safety Study; Intervention Model: Single Group Assignment; Masking: Open Label |
| Condition: |
Cardiovascular Disease |
| Intervention: |
Other: Perflutren Lipid Microspheres (DEFINITY®) |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| Participants were recruited from hospitals and clinics in the USA between February 2008 and April 2009 |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| There were no pre-assignment requirements for this study |
Reporting Groups
| Description | |
|---|---|
| Safety Population | No text entered. |
Participant Flow: Overall Study
| Safety Population | |
|---|---|
| STARTED | 1060 |
| COMPLETED | 1053 [1] |
| NOT COMPLETED | 7 |
| Withdrawal by Subject | 1 |
| No IV access | 5 |
| VSD | 1 |
| [1] | Participants who were analyzed for safety |
|---|
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Safety Population | No text entered. |
Baseline Measures
| Safety Population | |
|---|---|
|
Number of Participants
[units: participants] |
1053 |
|
Age
[units: participants] |
|
| Between 18 and 65 years | 609 |
| >=65 years | 444 |
|
Age
[units: years] Mean ± Standard Deviation |
61.3 ± 12.9 |
|
Gender
[units: participants] |
|
| Female | 400 |
| Male | 653 |
Outcome Measures
| 1. Primary: | The Number and Percentage of Patients With Death or Life Threatening Cardiopulmonary Events Occurring Following Definity Administration [ Time Frame: during or within 30 minutes of administration ] |
| 2. Secondary: | Serious Adverse Events [ Time Frame: Through 24 hours ] |
| 3. Secondary: | Adverse Events [ Time Frame: Through 24 hours ] |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| Principal Investigators are NOT employed by the organization sponsoring the study. |
| There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
Results Point of Contact:
Name/Title: Dana Washburn, M.D.
Organization: Lantheus Medical Imaging
phone: 978-671-8686
e-mail: dana.washburn@lantheus.com
Organization: Lantheus Medical Imaging
phone: 978-671-8686
e-mail: dana.washburn@lantheus.com
No publications provided
| Responsible Party: | Lantheus Medical Imaging |
| ClinicalTrials.gov Identifier: | NCT00625365 History of Changes |
| Other Study ID Numbers: | DMP 115-415 |
| Study First Received: | February 20, 2008 |
| Results First Received: | December 17, 2010 |
| Last Updated: | October 14, 2011 |
| Health Authority: | United States: Food and Drug Administration |