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The Effect of BIA 2-093 on the Steady-state Pharmacodynamic and Pharmacokinetic Profiles of Warfarin

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: NCT02287415
Recruitment Status : Completed
First Posted : November 10, 2014
Results First Posted : December 1, 2014
Last Update Posted : December 1, 2014
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Epilepsy
Interventions Drug: BIA 2-093
Drug: Warfarin
Enrollment 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group 1
Hide Arm/Group Description

Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin

BIA 2-093

Warfarin

Period Title: Overall Study
Started 13
Completed 13
Not Completed 0
Arm/Group Title Group 1
Hide Arm/Group Description

Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin

BIA 2-093

Warfarin

Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
<=18 years
0
   0.0%
Between 18 and 65 years
13
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
6
  46.2%
Male
7
  53.8%
1.Primary Outcome
Title Cmax - Maximum Steady-state Plasma Concentration
Hide Description [Not Specified]
Time Frame PHASE A: first 3 days; PHASE B: Days 1, 2, 4, 6, 7 and 8: pre-dose. PHASE C: Days 1, 3, 5 and 7: pre-dose; Day 8: 24 h post last-warfarin dose.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1
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Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin

BIA 2-093

Warfarin

Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: ng/mL
31652  (11150)
2.Secondary Outcome
Title Tmax - Time of Occurrence of Cmax
Hide Description [Not Specified]
Time Frame PHASE A: first 3 days; PHASE B: Days 1, 2, 4, 6, 7 and 8: pre-dose. PHASE C: Days 1, 3, 5 and 7: pre-dose; Day 8: 24 h post last-warfarin dose.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1
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Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin

BIA 2-093

Warfarin

Overall Number of Participants Analyzed 13
Median (Full Range)
Unit of Measure: hours
6
(1 to 12)
3.Secondary Outcome
Title AUCτ - Steady-state Area Under the Plasma Concentration-time Profile Over 24 h, the Dosing Interval
Hide Description [Not Specified]
Time Frame PHASE A: first 3 days; PHASE B: Days 1, 2, 4, 6, 7 and 8: pre-dose. PHASE C: Days 1, 3, 5 and 7: pre-dose; Day 8: 24 h post last-warfarin dose.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1
Hide Arm/Group Description:

Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin

BIA 2-093

Warfarin

Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: ng.h/mL
411834  (113305)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1
Hide Arm/Group Description

Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin

BIA 2-093

Warfarin

All-Cause Mortality
Group 1
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Group 1
Affected / at Risk (%)
Total   0/13 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group 1
Affected / at Risk (%)
Total   9/13 (69.23%) 
Blood and lymphatic system disorders   
Lymphadenopathy inguinal  1  1/13 (7.69%) 
Gastrointestinal disorders   
Epigastric discomfort  1  1/13 (7.69%) 
General disorders   
Asthenia  1  1/13 (7.69%) 
Musculoskeletal and connective tissue disorders   
Lumbago  1  1/13 (7.69%) 
Pain in elbow  1  1/13 (7.69%) 
Nervous system disorders   
Dizziness  1  1/13 (7.69%) 
Tension headache  1  1/13 (7.69%) 
Syncope  1  1/13 (7.69%) 
Vasovagal reaction  1  1/13 (7.69%) 
Lipothymia  1  1/13 (7.69%) 
Psychiatric disorders   
Irritability  1  1/13 (7.69%) 
Respiratory, thoracic and mediastinal disorders   
Epistaxis  1  1/13 (7.69%) 
Skin and subcutaneous tissue disorders   
Adhesive tape allergy  1  1/13 (7.69%) 
Vascular disorders   
Hot flashes  1  1/13 (7.69%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (4.1)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Head of Clinical Research
Organization: Bial – Portela & Cª, S.A.
Phone: +351 229 866 100
EMail: jose.rocha@bial.com
Layout table for additonal information
Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT02287415    
Other Study ID Numbers: BIA-2093-108
First Submitted: November 6, 2014
First Posted: November 10, 2014
Results First Submitted: November 28, 2014
Results First Posted: December 1, 2014
Last Update Posted: December 1, 2014