|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT01723618 |
|
Date of registration:
|
01/11/2012 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Pharmacokinetics of CRD007 in Patients With Abdominal Aorta Aneurisms.
|
|
Scientific title:
|
An Open-label, Randomised, Uncontrolled Trial Investigating the Pharmacokinetics of CRD007 After Single Dose Administration to Subjects With Abdominal Aortic Aneurysm (AAA) |
|
Date of first enrolment:
|
November 2012 |
|
Target sample size:
|
18 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT01723618 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label
|
|
Phase:
|
Phase 1
|
|
|
Countries of recruitment
|
|
Denmark
| | | | | | | |
|
Contacts
|
|
Name:
|
Nikolaj F Groendal, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Department of Vascular Surgery Viborg Hospital Heiberg Allé 4 DK-8800 Viborg Denmark |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Infra-renal abdominal aortic aneurysm
Exclusion Criteria:
- Significant concurrent disease or medical conditions that are deemed to interfere
with the pharmacokinetics or the safety of CRD007 conduct of the trial
Age minimum:
50 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Abdominal Aortic Aneurisms
|
|
Intervention(s)
|
|
Drug: CRD007
|
|
Primary Outcome(s)
|
|
Pharmacokinetics - Area under the plasma concentration curve (AUC)
[Time Frame: Pre-dose until 12 hours post-dose]
|
|
Pharmacokinetics - maximum plasma concentration (Cmax)
[Time Frame: Pre-dose and until 12 hours post-dose]
|
|
Pharmacokinetics - time to maximum plasma concentration (tmax)
[Time Frame: Pre-dose til 12 hours post-dose]
|
|
Pharmacokinetics - elimination half life (t1/2)
[Time Frame: pre-dose until 12 hours post-dose]
|
|
Secondary Outcome(s)
|
|
Dose linearity
[Time Frame: Pre-dose and until 12 hours post-dose]
|
|
Potential for accumulation
[Time Frame: Pre-dose untill 12 hours post-dose]
|
|
Secondary ID(s)
|
|
Cardoz-005
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|