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Efficacy Evaluation of Dotarem Compared to Gadovist in the Diagnosis of Peripheral Arterial Disease (DALIA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Guerbet
ClinicalTrials.gov Identifier:
NCT01026389
First received: December 3, 2009
Last updated: November 14, 2012
Last verified: November 2012
History of Changes
Results First Received: November 14, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Diagnostic
Condition: Peripheral Arterial Disease
Interventions: Drug: Dotarem
Drug: Gadovist

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period between october 2009 and January 2011. Patients were recruited in hospitals.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
3 patients were not randomized: 2 patients because of technical issue and one patient because of sponsor decision (inclusion period finished/ number of evaluable patients achieved)

Reporting Groups
  Description
Gadovist Patient received contrast-enhanced MRA with Gadovist
Dotarem Patients received contrast-enhanced MRA with Dotarem

Participant Flow:   Overall Study
    Gadovist     Dotarem  
STARTED     93     93  
COMPLETED     88     88  
NOT COMPLETED     5     5  
Withdrawal by Subject                 1                 3  
change of treatment, patient moved                 4                 2  



  Baseline Characteristics
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Reporting Groups
  Description
Gadovist Patient received contrast-enhanced MRA with Gadovist
Dotarem, Interventional Patients received contrast-enhanced MRA with Dotarem
Total Total of all reporting groups

Baseline Measures
    Gadovist     Dotarem, Interventional     Total  
Number of Participants  
[units: participants]
 		  93     93     186  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     48     48     96  
>=65 years     45     45     90  
Age  
[units: years]
Mean ± Standard Deviation 		  66.5  ± 10.2     66.8  ± 10.6     66.7  ± 10.4  
Gender  
[units: participants]
 		     
Female     21     18     39  
Male     72     75     147  
Region of Enrollment  
[units: participants]
 		     
Austria     19     18     37  
France     16     20     36  
Germany     7     7     14  
Italy     16     16     32  
Spain     35     32     67  



  Outcome Measures
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1.  Primary:   Intra-patient Accuracy (Percent Agreement), On-site Data   [ Time Frame: up to one month ]
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2.  Secondary:   Intra-patient Accuracy, in Off-site Readings   [ Time Frame: up to one month ]
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3.  Secondary:   Specificity   [ Time Frame: up to one month ]
  Show Outcome Measure 3

4.  Secondary:   Sensitivity   [ Time Frame: up to one month ]
  Show Outcome Measure 4


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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: Post M. A. Clinical Unit Manager
Organization: Guerbet
phone: +33 1 45 91 50 00
e-mail: corinne.dubourdieu@guerbet-group.com


No publications provided


Responsible Party: Guerbet
ClinicalTrials.gov Identifier: NCT01026389     History of Changes
Other Study ID Numbers: DGD 44-045
Study First Received: December 3, 2009
Results First Received: November 14, 2012
Last Updated: November 14, 2012
Health Authority: Austria: Agency for Health and Food Safety
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Italy: Ministry of Health
Spain: Ministry of Health