Trial record 1 of 89 for:    DIAS 4
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Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke (DIAS-4)

This study has been terminated.
(The recruitment into DIAS4 has been stopped as the result of DIAS 3 indicates that the study is unlikely to reach its primary endpoint with the current protocol)
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT00856661
First received: March 5, 2009
Last updated: November 18, 2015
Last verified: November 2015
Results First Received: October 6, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Stroke
Interventions: Drug: Desmoteplase
Drug: Placebo

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Desmoteplase 90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
Placebo Placebo: IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset

Participant Flow:   Overall Study
    Desmoteplase     Placebo  
STARTED     135 [1]   135 [1]
Treated     126     131  
Randomized Not Treated     9     4  
COMPLETED     108     106  
NOT COMPLETED     27     29  
Death                 15                 18  
Protocol Violation                 2                 1  
Withdrawal by Subject                 1                 2  
Lost to Follow-up                 1                 3  
Physician Judgement                 8                 5  
[1] Randomised



  Baseline Characteristics
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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
  Description
Desmoteplase Desmoteplase: 90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
Placebo Placebo: IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
Total Total of all reporting groups

Baseline Measures
    Desmoteplase     Placebo     Total  
Number of Participants  
[units: participants]
  135     135     270  
Age  
[units: years]
Mean (Standard Deviation)
  69.1  (11.1)     68.2  (12.5)     68.6  (11.8)  
Gender  
[units: participants]
     
Female     72     69     141  
Male     63     66     129  
Race/Ethnicity, Customized  
[units: participants]
     
White     111     115     226  
Black or african americal     11     9     20  
Asian     7     6     13  
Other     6     5     11  



  Outcome Measures
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1.  Primary:   Modified Rankin Scale Score (mRS) (Percentage of Participants With mRS Scores 0-2)   [ Time Frame: Day 90 ]

2.  Secondary:   National Institutes of Health Stroke Scale (NIHSS) Score. (Percentage of Participants With NIHSS Scores <=1 or NIHSS Decrease >=8)   [ Time Frame: 90 days ]

3.  Secondary:   Composite of mRS & NIHSS Response (Percentage of Participants With mRS Scores 0-2 and (NIHSS <= 1 or NIHSS Decrease >= 8)   [ Time Frame: Day 90 ]

4.  Secondary:   Modified Ranking Scale Score (Using the Ordinal Scale)   [ Time Frame: Day 90 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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 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.


Results Point of Contact:  
Name/Title: study director
Organization: H. Lundbeck A/S
e-mail: LundbeckClinicalTrials@Lundbeck.com


No publications provided


Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT00856661     History of Changes
Other Study ID Numbers: 12649A
2008-005539-14 ( EudraCT Number )
Study First Received: March 5, 2009
Results First Received: October 6, 2015
Last Updated: November 18, 2015
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: Ministry of Health
Canada: Health Canada
Chile: Comisión Nacional de Investigación Científica y Tecnológica
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
Ireland: Irish Medicines Board
Italy: The Italian Medicines Agency
Mexico: Ministry of Health
Norway: Norwegian Medicines Agency
South Africa: Medicines Control Council
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration