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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01026389
Recruitment Status : Completed
First Posted : December 4, 2009
Results First Posted : December 11, 2012
Last Update Posted : December 11, 2012
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Diagnostic
Condition: Peripheral Arterial Disease
Interventions: Drug: Dotarem
Drug: Gadovist

  Participant Flow

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
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 
Withdrawal by Subject                1                3 
change of treatment, patient moved                4                2 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
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 
Overall Participants Analyzed 
[Units: Participants]
 93   93   186 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   48   48   96 
>=65 years   45   45   90 
[Units: Years]
Mean (Standard Deviation)
 66.5  (10.2)   66.8  (10.6)   66.7  (10.4) 
[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

1.  Primary:   Intra-patient Accuracy (Percent Agreement), On-site Data   [ Time Frame: up to one month ]

2.  Secondary:   Intra-patient Accuracy, in Off-site Readings   [ Time Frame: up to one month ]

3.  Secondary:   Specificity   [ Time Frame: up to one month ]

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

  Serious Adverse Events

  Other Adverse Events

  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.

  More Information

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.

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

Responsible Party: Guerbet
ClinicalTrials.gov Identifier: NCT01026389     History of Changes
Other Study ID Numbers: DGD 44-045
First Submitted: December 3, 2009
First Posted: December 4, 2009
Results First Submitted: November 14, 2012
Results First Posted: December 11, 2012
Last Update Posted: December 11, 2012