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Trial record 1 of 1 for:    NCT00794573
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Evaluation of Varenicline (Champix) in Smoking Cessation for Patients Post-Acute Coronary Syndrome (EVITA) Trial (EVITA)

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ClinicalTrials.gov Identifier: NCT00794573
Recruitment Status : Completed
First Posted : November 20, 2008
Results First Posted : May 23, 2019
Last Update Posted : May 23, 2019
Sponsor:
Collaborators:
St. Michael's Hospital, Toronto
Sunnybrook Health Sciences Centre
Queen Elizabeth II Health Sciences Centre
Information provided by (Responsible Party):
Mark Eisenberg, McGill University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Acute Coronary Syndrome
Interventions Drug: varenicline
Other: placebo
Enrollment 302
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment. placebo for 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
Period Title: Overall Study
Started 151 151
Completed 113 106
Not Completed 38 45
Reason Not Completed
Death             3             0
Withdrawal by Subject             9             12
Lost to Follow-up             26             33
Arm/Group Title Varenicline Placebo Total
Hide Arm/Group Description 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment. placebo for 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment. Total of all reporting groups
Overall Number of Baseline Participants 151 151 302
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 151 participants 151 participants 302 participants
54.7  (8.4) 55.3  (10.3) 55.0  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants 151 participants 302 participants
Female
39
  25.8%
36
  23.8%
75
  24.8%
Male
112
  74.2%
115
  76.2%
227
  75.2%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 151 participants 151 participants 302 participants
104 96 200
United States Number Analyzed 151 participants 151 participants 302 participants
47 55 102
Smoking duration  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 151 participants 151 participants 302 participants
35.1  (11.4) 36.7  (11.8) 35.9  (11.6)
Cigarettes per day at baseline  
Mean (Standard Deviation)
Unit of measure:  Cigarettes smoked/day
Number Analyzed 151 participants 151 participants 302 participants
21.9  (10.9) 21.0  (10.3) 21.4  (10.6)
Fagerstrom Test for Nicotine Dependence score   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants 151 participants 301 participants
0-3 (mild)
30
  20.0%
29
  19.2%
59
  19.6%
4-6 (moderate)
77
  51.3%
79
  52.3%
156
  51.8%
7+ (severe)
43
  28.7%
43
  28.5%
86
  28.6%
[1]
Measure Analysis Population Description: One participant in the varenicline arm was missing a response on the Fagerstrom questionnaire.
Other smoker(s) at home  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 151 participants 151 participants 302 participants
73 53 126
Hyperlipidemia  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 151 participants 151 participants 302 participants
96 106 202
Hypertension  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 151 participants 151 participants 302 participants
79 70 149
Diabetes  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 151 participants 151 participants 302 participants
33 26 59
Prior use of antidepressants  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 151 participants 151 participants 302 participants
16 9 25
Prior myocardial infarction  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 151 participants 151 participants 302 participants
25 28 53
Prior percutaneous coronary intervention  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 151 participants 151 participants 302 participants
18 28 46
Prior coronary artery bypass graft  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 151 participants 151 participants 302 participants
4 5 9
Prior transient ischemic attack or cerebrovascular accident  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 151 participants 151 participants 302 participants
3 6 9
ST-segment elevation myocardial infarction (at baseline admission)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 151 participants 151 participants 302 participants
86 83 169
Non ST-segment elevation myocardial infarction (at baseline admission)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 151 participants 151 participants 302 participants
53 61 114
Unstable angina (at baseline admission)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 151 participants 151 participants 302 participants
12 7 19
Cardiac catheterization (at baseline admission)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 151 participants 151 participants 302 participants
149 148 297
Percutaneous coronary intervention (at baseline admission)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 151 participants 151 participants 302 participants
126 129 255
Coronary artery bypass graft (at baseline admission)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 151 participants 151 participants 302 participants
14 4 18
Length of stay (baseline admission)  
Median (Inter-Quartile Range)
Unit of measure:  Days
Number Analyzed 151 participants 151 participants 302 participants
3
(2 to 5)
3
(2 to 4)
3
(2 to 4)
Time from admission to first dose of study medication (baseline admission)  
Median (Inter-Quartile Range)
Unit of measure:  Days
Number Analyzed 151 participants 151 participants 302 participants
2
(1 to 3)
2
(1 to 3)
2
(1 to 3)
1.Primary Outcome
Title 7-Day Point Prevalence Smoking Abstinence
Hide Description 7-day point prevalence abstinence at week 24, defined as self-reported abstinence in the past week and exhaled carbon monoxide ≤10 ppm
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all patients except those who died. For the primary analysis, participants who were lost to follow-up or withdrew were assumed to have gone back to smoking at baseline rates.
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
placebo for 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
Overall Number of Participants Analyzed 148 151
Measure Type: Count of Participants
Unit of Measure: Participants
70
  47.3%
49
  32.5%
2.Primary Outcome
Title Continuous Smoking Abstinence
Hide Description Continuous abstinence, defined as self-reported abstinence since baseline and exhaled carbon monoxide ≤10 ppm at all follow-up visits up to and including week 24.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all patients except those who died. For the primary analysis, participants who were lost to follow-up or withdrew were assumed to have gone back to smoking at baseline rates.
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
placebo for 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
Overall Number of Participants Analyzed 148 151
Measure Type: Count of Participants
Unit of Measure: Participants
53
  35.8%
39
  25.8%
3.Secondary Outcome
Title 7-Day Point Prevalence Smoking Abstinence
Hide Description 7-day point prevalence abstinence at week 52, defined as self-reported abstinence in the past week and exhaled carbon monoxide ≤10 ppm
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all patients except those who died. For the primary analysis, participants who were lost to follow-up or withdrew were assumed to have gone back to smoking at baseline rates.
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
placebo for 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
Overall Number of Participants Analyzed 148 151
Measure Type: Count of Participants
Unit of Measure: Participants
59
  39.9%
44
  29.1%
4.Secondary Outcome
Title Continuous Smoking Abstinence
Hide Description Continuous abstinence, defined as self-reported abstinence since baseline and exhaled carbon monoxide ≤10 ppm at all follow-up visits up to and including week 52.
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all patients except those who died. For the primary analysis, participants who were lost to follow-up or withdrew were assumed to have gone back to smoking at baseline rates.
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
placebo for 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
Overall Number of Participants Analyzed 148 151
Measure Type: Count of Participants
Unit of Measure: Participants
46
  31.1%
32
  21.2%
5.Secondary Outcome
Title 7-Day Point Prevalence Smoking Abstinence
Hide Description 7-day point prevalence abstinence at week 12, defined as self-reported abstinence in the past week and exhaled carbon monoxide ≤10 ppm
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all patients except those who died. For the primary analysis, participants who were lost to follow-up or withdrew were assumed to have gone back to smoking at baseline rates.
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
placebo for 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
Overall Number of Participants Analyzed 149 151
Measure Type: Count of Participants
Unit of Measure: Participants
86
  57.7%
55
  36.4%
6.Secondary Outcome
Title Continuous Smoking Abstinence
Hide Description Continuous abstinence, defined as self-reported abstinence since baseline and exhaled carbon monoxide ≤10 ppm at all follow-up visits up to and including week 12.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all patients except those who died. For the primary analysis, participants who were lost to follow-up or withdrew were assumed to have gone back to smoking at baseline rates.
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
placebo for 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
Overall Number of Participants Analyzed 149 151
Measure Type: Count of Participants
Unit of Measure: Participants
66
  44.3%
45
  29.8%
7.Secondary Outcome
Title 7-Day Point Prevalence Smoking Abstinence
Hide Description 7-day point prevalence abstinence at week 4, defined as self-reported abstinence in the past week and exhaled carbon monoxide ≤10 ppm
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all patients except those who died. For the primary analysis, participants who were lost to follow-up or withdrew were assumed to have gone back to smoking at baseline rates.
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
placebo for 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
Overall Number of Participants Analyzed 150 151
Measure Type: Count of Participants
Unit of Measure: Participants
90
  60.0%
57
  37.7%
8.Secondary Outcome
Title Continuous Smoking Abstinence
Hide Description Continuous abstinence, defined as self-reported abstinence since baseline and exhaled carbon monoxide ≤10 ppm at all follow-up visits up to and including week 4.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all patients except those who died. For the primary analysis, participants who were lost to follow-up or withdrew were assumed to have gone back to smoking at baseline rates.
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
placebo for 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
Overall Number of Participants Analyzed 150 151
Measure Type: Count of Participants
Unit of Measure: Participants
78
  52.0%
49
  32.5%
9.Secondary Outcome
Title Reduction in Daily Cigarette Consumption by 50% or Greater
Hide Description [Not Specified]
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all patients except those who died. For the primary analysis, participants who were lost to follow-up or withdrew were assumed to have gone back to smoking at baseline rates. Missing data for one participant in the varenicline arm.
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
placebo for 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
Overall Number of Participants Analyzed 147 151
Measure Type: Count of Participants
Unit of Measure: Participants
85
  57.8%
75
  49.7%
10.Secondary Outcome
Title Reduction in Daily Cigarette Consumption by 50% or Greater
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all patients except those who died. For the primary analysis, participants who were lost to follow-up or withdrew were assumed to have gone back to smoking at baseline rates. Missing data for one participant in the varenicline arm.
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
placebo for 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
Overall Number of Participants Analyzed 147 151
Measure Type: Count of Participants
Unit of Measure: Participants
99
  67.3%
84
  55.6%
11.Secondary Outcome
Title Reduction in Daily Cigarette Consumption by 50% or Greater
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all patients except those who died. For the primary analysis, participants who were lost to follow-up or withdrew were assumed to have gone back to smoking at baseline rates. Missing data for one participant in the varenicline arm.
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
placebo for 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
Overall Number of Participants Analyzed 148 151
Measure Type: Count of Participants
Unit of Measure: Participants
115
  77.7%
93
  61.6%
12.Secondary Outcome
Title Reduction in Daily Cigarette Consumption by 50% or Greater
Hide Description [Not Specified]
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all patients except those who died. For the primary analysis, participants who were lost to follow-up or withdrew were assumed to have gone back to smoking at baseline rates. Missing data for one participant in the varenicline arm.
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description:
0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
placebo for 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
Overall Number of Participants Analyzed 149 151
Measure Type: Count of Participants
Unit of Measure: Participants
130
  87.2%
113
  74.8%
Time Frame All-Cause Mortality: 52 weeks; Serious Adverse Events: within 30 days of treatment discontinuation; Adverse Events: 12 weeks (treatment period)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Varenicline Placebo
Hide Arm/Group Description 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment. placebo for 0.5 mg tablet once a day for the first three days, a 0.5 mg tablet twice a day for the following four days, and a 1.0 mg tablet twice a day for the remainder of the 12-week treatment.
All-Cause Mortality
Varenicline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   3/151 (1.99%)      0/151 (0.00%)    
Hide Serious Adverse Events
Varenicline Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/151 (11.92%)      17/151 (11.26%)    
Cardiac disorders     
Major Adverse Cardiovascular Event (Any)  [1]  6/151 (3.97%)  6 7/151 (4.64%)  8
Myocardial Infarction   3/151 (1.99%)  3 3/151 (1.99%)  3
Unstable Angina   1/151 (0.66%)  1 5/151 (3.31%)  5
Arrhythmia   1/151 (0.66%)  1 0/151 (0.00%)  0
Ischemic Cardiomyopathy   0/151 (0.00%)  0 1/151 (0.66%)  1
Sick Sinus Syndrome   1/151 (0.66%)  1 0/151 (0.00%)  0
Cardiovascular Death   2/151 (1.32%)  2 0/151 (0.00%)  0
Gastrointestinal disorders     
Gastrointestinal Bleed   2/151 (1.32%)  2 0/151 (0.00%)  0
Partial Bowel Obstruction   0/151 (0.00%)  0 1/151 (0.66%)  1
Melena   0/151 (0.00%)  0 1/151 (0.66%)  1
General disorders     
Dehydration   1/151 (0.66%)  1 0/151 (0.00%)  0
Syncope   1/151 (0.66%)  1 0/151 (0.00%)  0
Motor Vehicle Collision   0/151 (0.00%)  0 1/151 (0.66%)  1
Immune system disorders     
Allergic Reaction   0/151 (0.00%)  0 1/151 (0.66%)  1
Infections and infestations     
Sternal Wound Infection   1/151 (0.66%)  1 0/151 (0.00%)  0
Investigations     
Hospitalization for Suspected Unstable Angina - Ruled Out by Angiogram   2/151 (1.32%)  2 0/151 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Exacerbation of Rheumatoid Arthritis   0/151 (0.00%)  0 1/151 (0.66%)  1
Non-Cardiac Chest Pain   0/151 (0.00%)  0 1/151 (0.66%)  1
Psychiatric disorders     
Hospitalization for Depression   1/151 (0.66%)  1 0/151 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute Exacerbation of Chronic Obstructive Pulmonary Disorder   0/151 (0.00%)  0 1/151 (0.66%)  1
Skin and subcutaneous tissue disorders     
Septic Cellulitis   1/151 (0.66%)  1 0/151 (0.00%)  0
Surgical and medical procedures     
Hospitalization for Bowel Surgery   1/151 (0.66%)  1 0/151 (0.00%)  0
Vascular disorders     
Transient Ischemic Attack   1/151 (0.66%)  1 0/151 (0.00%)  0
Pulmonary Embolism   1/151 (0.66%)  1 0/151 (0.00%)  0
Ruptured Pseudoaneurysm   0/151 (0.00%)  0 1/151 (0.66%)  1
Indicates events were collected by systematic assessment
[1]
cardiovascular death, myocardial infarction, or unstable angina
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Varenicline Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   92/151 (60.93%)      70/151 (46.36%)    
General disorders     
Insomnia   27/151 (17.88%)  19/151 (12.58%) 
Nausea   21/151 (13.91%)  13/151 (8.61%) 
Abnormal Dreams   23/151 (15.23%)  7/151 (4.64%) 
Nightmares   14/151 (9.27%)  7/151 (4.64%) 
Headache   8/151 (5.30%)  12/151 (7.95%) 
Irritability   6/151 (3.97%)  13/151 (8.61%) 
Increased Appetite   8/151 (5.30%)  9/151 (5.96%) 
Constipation   9/151 (5.96%)  6/151 (3.97%) 
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Mark Eisenberg, MD MPH
Organization: Jewish General Hospital / McGill University
Phone: 5143408222
EMail: mark.eisenberg@ladydavis.ca
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Mark Eisenberg, McGill University
ClinicalTrials.gov Identifier: NCT00794573    
Other Study ID Numbers: EVITA
First Submitted: November 19, 2008
First Posted: November 20, 2008
Results First Submitted: April 26, 2019
Results First Posted: May 23, 2019
Last Update Posted: May 23, 2019