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Study Effect of VIA-2291 on Vascular Inflammation

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ClinicalTrials.gov Identifier: NCT00358826
Recruitment Status : Completed
First Posted : August 1, 2006
Results First Posted : July 23, 2012
Last Update Posted : July 23, 2012
Sponsor:
Collaborator:
Montreal Heart Institute
Information provided by (Responsible Party):
Tallikut Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Coronary Artery Disease
Interventions Drug: VIA-2291
Drug: Placebo
Enrollment 191
Recruitment Details Patients had an Acute Coronary Syndrome (ACS) within 3 weeks prior to randomization
Pre-assignment Details Subset of patients agreed to participate in a Multi-Detector Computed Tomography (MDCT) substudy for an additional 12 weeks of treatment for a total of 24 weeks
Arm/Group Title VIA-2291 25 mg VIA-2291 50 mg VIA-2291 100 mg Placebo VIA-2291 25 mg MDCT Substudy VIA-2291 50 mg MDCT Substudy VIA-2291 100 mg MDCT Substudy Placebo MDCT Substudy
Hide Arm/Group Description VIA-2291, 25 mg, oral dosing, daily, 12 weeks VIA-2291, 50 mg, oral dosing, daily, 12 weeks VIA-2291, 100 mg, oral dosing, daily, 12 weeks Matching Placebo, 12 weeks VIA-2291, 25 mg, oral dosing, daily, 24 weeks VIA-2291, 50 mg, oral dosing, daily, 24 weeks VIA-2291, 100 mg, oral dosing, daily, 24 weeks Matching Placebo, 24 weeks
Period Title: Core Study
Started 49 46 44 52 0 0 0 0
Completed 46 41 42 50 0 0 0 0
Not Completed 3 5 2 2 0 0 0 0
Reason Not Completed
Adverse Event             1             3             1             1             0             0             0             0
Withdrawal by Subject             2             2             0             0             0             0             0             0
Lost to Follow-up             0             0             0             1             0             0             0             0
Physician Decision             0             0             1             0             0             0             0             0
Period Title: MDCT Substudy
Started 0 0 0 0 25 22 19 27
Completed 0 0 0 0 24 20 19 27
Not Completed 0 0 0 0 1 2 0 0
Reason Not Completed
Adverse Event             0             0             0             0             1             0             0             0
Lost to Follow-up             0             0             0             0             0             1             0             0
Withdrawal by Subject             0             0             0             0             0             1             0             0
Arm/Group Title VIA-2291 25 mg VIA-2291 50 mg VIA-2291 100 mg Placebo Total
Hide Arm/Group Description VIA-2291, 25 mg, oral dosing, daily, 12 weeks VIA-2291, 50 mg, oral dosing, daily, 12 weeks VIA-2291, 100 mg, oral dosing, daily, 12 weeks Matching Placebo, oral dosing, 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 49 46 44 52 191
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 46 participants 44 participants 52 participants 191 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
38
  77.6%
35
  76.1%
35
  79.5%
41
  78.8%
149
  78.0%
>=65 years
11
  22.4%
11
  23.9%
9
  20.5%
11
  21.2%
42
  22.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants 46 participants 44 participants 52 participants 191 participants
56.4  (9.54) 57.3  (10.01) 57.6  (9.44) 56.6  (9.78) 57.0  (9.63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 46 participants 44 participants 52 participants 191 participants
Female
8
  16.3%
5
  10.9%
6
  13.6%
11
  21.2%
30
  15.7%
Male
41
  83.7%
41
  89.1%
38
  86.4%
41
  78.8%
161
  84.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 49 participants 46 participants 44 participants 52 participants 191 participants
Canada 34 33 31 34 132
United States 15 13 13 18 59
1.Primary Outcome
Title Change From Baseline on ex Vivo Leukotriene B4 Synthesis in Whole Blood
Hide Description [Not Specified]
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Core Study Evaluable Population
Arm/Group Title VIA-2291 25 mg VIA-2291 50 mg VIA-2291 100 mg Placebo
Hide Arm/Group Description:
VIA-2291, 25 mg, oral dosing, daily, 12 weeks
VIA-2291, 50 mg, oral dosing, daily, 12 weeks
VIA-2291, 100 mg, oral dosing, daily, 12 weeks
Matching Placebo, oral dosing, 12 weeks
Overall Number of Participants Analyzed 43 36 38 45
Least Squares Mean (95% Confidence Interval)
Unit of Measure: pg/mL
-88126
(-100056 to -76196)
-95703
(-108810 to -82597)
-122668
(-135359 to -109976)
-20843
(-32509 to -9179)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VIA-2291 25 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Adjusted using Dunnett's method.
Method ANCOVA
Comments The model included treatment effect, with baseline value as a covariate.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection VIA-2291 50 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Adjusted using Dunnett's method.
Method ANCOVA
Comments The model included treatment effect, with baseline value as a covariate.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection VIA-2291 100 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Adjusted using Dunnett's method.
Method ANCOVA
Comments The model included treatment effect, with baseline value as a covariate.
2.Secondary Outcome
Title Change From Baseline in Leukotriene E4 (LTE4)
Hide Description Urinary LTE4 is expressed in pg per mg Creatinine (pg/mg Cr) to normalize for renal excretion rate
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Core Study Evaluable Population
Arm/Group Title VIA-2291 25 mg VIA-2291 50 mg VIA-2291 100 mg Placebo
Hide Arm/Group Description:
VIA-2291, 25 mg, oral dosing, daily, 12 weeks
VIA-2291, 50 mg, oral dosing, daily, 12 weeks
VIA-2291, 100 mg, oral dosing, daily, 12 weeks
Matching Placebo, oral dosing, 12 weeks
Overall Number of Participants Analyzed 42 38 35 44
Least Squares Mean (95% Confidence Interval)
Unit of Measure: pg/mg Cr
-26.8
(-39.3 to -14.4)
-38.6
(-51.7 to -25.5)
-56.5
(-70.2 to -42.9)
8.4
(-3.8 to 20.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VIA-2291 25 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Adjusted using Dunnett's method.
Method ANCOVA
Comments The model included treatment effect, with baseline value as a covariate.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection VIA-2291 50 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Adjusted using Dunnett's method.
Method ANCOVA
Comments The model included treatment effect, with baseline value as a covariate.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection VIA-2291 100 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Adjusted using Dunnett's method.
Method ANCOVA
Comments The model included treatment effect, with baseline value as a covariate.
3.Secondary Outcome
Title Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - Core Study
Hide Description [Not Specified]
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable Population
Arm/Group Title VIA-2291 25 mg VIA-2291 50 mg VIA-2291 100 mg Placebo
Hide Arm/Group Description:
VIA-2291, 25 mg, oral dosing, daily, 12 weeks
VIA-2291, 50 mg, oral dosing, daily, 12 weeks
VIA-2291, 100 mg, oral dosing, daily, 12 weeks
Matching Placebo, oral dosing, 12 weeks
Overall Number of Participants Analyzed 44 38 38 48
Median (Inter-Quartile Range)
Unit of Measure: mg/L
-0.2
(-1.1 to 0.4)
-0.1
(-1.9 to 0.1)
-0.3
(-0.8 to 0.1)
-0.2
(-0.9 to 0.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VIA-2291 25 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.656
Comments Adjusted using Dunnett's method.
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection VIA-2291 50 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.863
Comments Adjusted using Dunnett's method.
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection VIA-2291 100 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.996
Comments Adjusted using Dunnett's method.
Method ANCOVA
Comments [Not Specified]
4.Other Pre-specified Outcome
Title Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) - MDCT Substudy
Hide Description [Not Specified]
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable Population of the MDCT substudy
Arm/Group Title VIA-2291 25 mg MDCT Substudy VIA-2291 50 mg MDCT Substudy VIA-2291 100 mg MDCT Substudy Placebo MDCT Substudy
Hide Arm/Group Description:
VIA-2291, 25 mg, oral dosing, daily, 24 weeks
VIA-2291, 50 mg, oral dosing, daily, 24 weeks
VIA-2291, 100 mg, oral dosing, daily, 24 weeks
Matching Placebo, oral dosing, 24 weeks
Overall Number of Participants Analyzed 23 20 18 27
Median (Inter-Quartile Range)
Unit of Measure: mg/L
-0.4
(-1.2 to 0.3)
-0.2
(-3.7 to 0.2)
-0.4
(-3.9 to -0.2)
0.0
(-0.5 to 1.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VIA-2291 25 mg MDCT Substudy, Placebo MDCT Substudy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.331
Comments Adjusted using Dunnett's method.
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection VIA-2291 50 mg MDCT Substudy, Placebo MDCT Substudy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.606
Comments Adjusted using Dunnett's method.
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection VIA-2291 100 mg MDCT Substudy, Placebo MDCT Substudy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Adjusted using Dunnett's method.
Method ANOVA
Comments [Not Specified]
5.Other Pre-specified Outcome
Title Change From Baseline in Noncalcified Plaque Volume
Hide Description [Not Specified]
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable Population
Arm/Group Title VIA-2291 25 mg MDCT Substudy VIA-2291 50 mg MDCT Substudy VIA-2291 100 mg MDCT Substudy Placebo MDCT Substudy
Hide Arm/Group Description:
VIA-2291, 25 mg, oral dosing, daily, 24 weeks
VIA-2291, 50 mg, oral dosing, daily, 24 weeks
VIA-2291, 100 mg, oral dosing, daily, 24 weeks
Matching Placebo, oral dosing, 24 weeks
Overall Number of Participants Analyzed 7 8 7 12
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mm^3
-1.55
(-5.62 to 2.51)
-5.6
(-9.49 to -1.71)
0.15
(-3.84 to 4.14)
2.83
(-0.18 to 5.84)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VIA-2291 25 mg MDCT Substudy, Placebo MDCT Substudy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.22
Comments Dunnett test compared with Placebo
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection VIA-2291 50 mg MDCT Substudy, Placebo MDCT Substudy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.005
Comments Dunnett test compared with Placebo
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection VIA-2291 100 mg MDCT Substudy, Placebo MDCT Substudy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.60
Comments Dunnett test compared with Placebo
Method ANCOVA
Comments [Not Specified]
6.Other Pre-specified Outcome
Title Change From Baseline in Mean Plaque Density
Hide Description Plaque density is expressed in Hounsfield Units (HU)
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable Population
Arm/Group Title VIA-2291 25 mg VIA-2291 50 mg VIA-2291 100 mg Placebo
Hide Arm/Group Description:
VIA-2291, 25 mg, oral dosing, daily, 12 weeks
VIA-2291, 50 mg, oral dosing, daily, 12 weeks
VIA-2291, 100 mg, oral dosing, daily, 12 weeks
Matching Placebo, oral dosing, 12 weeks
Overall Number of Participants Analyzed 7 8 7 12
Least Squares Mean (95% Confidence Interval)
Unit of Measure: HU
19.11
(-1.51 to 39.74)
7.39
(-11.96 to 26.74)
12.22
(-8.38 to 32.82)
12.42
(-3.32 to 28.17)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VIA-2291 25 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.92
Comments Dunnett test compared with Placebo
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection VIA-2291 50 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.96
Comments Dunnett test compared with Placebo
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection VIA-2291 100 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments Dunnett test compared with Placebo
Method ANCOVA
Comments [Not Specified]
7.Other Pre-specified Outcome
Title Change From Baseline in Percent Stenosis
Hide Description [Not Specified]
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable Population
Arm/Group Title VIA-2291 25 mg VIA-2291 50 mg VIA-2291 100 mg Placebo
Hide Arm/Group Description:
VIA-2291, 25 mg, oral dosing, daily, 12 weeks
VIA-2291, 50 mg, oral dosing, daily, 12 weeks
VIA-2291, 100 mg, oral dosing, daily, 12 weeks
Matching Placebo, oral dosing, 12 weeks
Overall Number of Participants Analyzed 7 8 7 12
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percentage
-0.11
(-8.24 to 8.03)
11.45
(3.73 to 19.17)
2.36
(-5.7 to 10.42)
1.19
(-4.95 to 7.32)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VIA-2291 25 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.99
Comments Dunnett test compared with Placebo
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection VIA-2291 50 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments Dunnett test compared with Placebo
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection VIA-2291 100 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.99
Comments Dunnett test compared with Placebo
Method ANCOVA
Comments [Not Specified]
Time Frame 12 weeks for Core Study and 24 weeks for MDCT substudy
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title VIA-2291 25 mg VIA-2291 50 mg VIA-2291 100 mg Placebo
Hide Arm/Group Description VIA-2291, 25 mg, oral dosing, daily, 12 weeks VIA-2291, 50 mg, oral dosing, daily, 12 weeks VIA-2291, 100 mg, oral dosing, daily, 12 weeks Matching Placebo, oral dosing, 12 weeks
All-Cause Mortality
VIA-2291 25 mg VIA-2291 50 mg VIA-2291 100 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
VIA-2291 25 mg VIA-2291 50 mg VIA-2291 100 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/49 (8.16%)      3/46 (6.52%)      7/44 (15.91%)      5/52 (9.62%)    
Cardiac disorders         
Angina Unstable  1  1/49 (2.04%)  1 0/46 (0.00%)  0 2/44 (4.55%)  2 0/52 (0.00%)  0
Angina Pectoris  1  0/49 (0.00%)  0 1/46 (2.17%)  1 1/44 (2.27%)  1 0/52 (0.00%)  0
Cardiac Failure Congestive  1  1/49 (2.04%)  1 0/0  0 0/44 (0.00%)  0 1/52 (1.92%)  1
Coronary Artery Disease  1  0/49 (0.00%)  0 1/46 (2.17%)  1 0/44 (0.00%)  0 0/52 (0.00%)  0
Pericardial Effusion  1  0/49 (0.00%)  0 0/46 (0.00%)  0 1/44 (2.27%)  1 0/52 (0.00%)  0
Acute Coronary Syndrome  1  0/49 (0.00%)  0 0/46 (0.00%)  0 0/44 (0.00%)  0 1/52 (1.92%)  1
Eye disorders         
Retinal Detachment  1  0/49 (0.00%)  0 0/46 (0.00%)  0 0/44 (0.00%)  0 1/52 (1.92%)  1
Gastrointestinal disorders         
Colitis Ischaemic  1  0/49 (0.00%)  0 0/46 (0.00%)  0 1/44 (2.27%)  1 0/52 (0.00%)  0
General disorders         
Non-cardiac Chest Pain  1  1/49 (2.04%)  1 0/46 (0.00%)  0 1/44 (2.27%)  1 0/52 (0.00%)  0
Chest Discomfort  1  0/49 (0.00%)  0 0/46 (0.00%)  0 1/44 (2.27%)  1 0/52 (0.00%)  0
Chest Pain  1  0/49 (0.00%)  0 0/46 (0.00%)  0 1/44 (2.27%)  1 0/52 (0.00%)  0
Pneumonia  1  0/49 (0.00%)  0 0/46 (0.00%)  0 0/44 (0.00%)  0 1/52 (1.92%)  1
Infections and infestations         
Bronchitis  1  0/49 (0.00%)  0 0/46 (0.00%)  0 1/44 (2.27%)  1 0/52 (0.00%)  0
Diverticulitis  1  0/49 (0.00%)  0 0/46 (0.00%)  0 1/44 (2.27%)  1 0/52 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Non-hodgkin's Lymphoma  1  0/49 (0.00%)  0 0/46 (0.00%)  0 0/44 (0.00%)  0 1/52 (1.92%)  1
Nervous system disorders         
Presyncope  1  0/49 (0.00%)  0 1/46 (2.17%)  1 0/44 (0.00%)  0 0/52 (0.00%)  0
Syncope  1  1/49 (2.04%)  1 0/46 (0.00%)  0 0/44 (0.00%)  0 0/52 (0.00%)  0
Vascular disorders         
Accelerated Hypertension  1  1/49 (2.04%)  1 0/46 (0.00%)  0 0/44 (0.00%)  0 0/52 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (9.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
VIA-2291 25 mg VIA-2291 50 mg VIA-2291 100 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   42/49 (85.71%)      43/46 (93.48%)      42/44 (95.45%)      45/52 (86.54%)    
Cardiac disorders         
Angina Pectoris  1  3/49 (6.12%)  3 8/46 (17.39%)  8 7/44 (15.91%)  7 5/52 (9.62%)  5
Gastrointestinal disorders         
Nausea  1  3/49 (6.12%)  3 1/46 (2.17%)  1 4/44 (9.09%)  4 1/52 (1.92%)  1
Dspepsia  1  3/49 (6.12%)  3 1/46 (2.17%)  1 3/44 (6.82%)  3 1/52 (1.92%)  1
General disorders         
Fatigue  1  4/49 (8.16%)  4 6/46 (13.04%)  6 7/44 (15.91%)  7 5/52 (9.62%)  5
Non-cardiac Chest Pain  1  5/49 (10.20%)  5 3/46 (6.52%)  3 4/44 (9.09%)  4 4/52 (7.69%)  4
Chest pain  1  3/49 (6.12%)  3 2/46 (4.35%)  2 2/44 (4.55%)  2 0/52 (0.00%)  0
Infections and infestations         
Nasopharyngitis  1  1/49 (2.04%)  1 5/46 (10.87%)  5 0/44 (0.00%)  0 4/52 (7.69%)  4
Upper Respiratory Tract Infection  1  2/49 (4.08%)  2 2/46 (4.35%)  2 1/44 (2.27%)  1 4/52 (7.69%)  4
Injury, poisoning and procedural complications         
Contusion  1  5/49 (10.20%)  5 2/46 (4.35%)  2 4/44 (9.09%)  4 7/52 (13.46%)  7
Investigations         
Alanine Aminotransferase Increased  1  5/49 (10.20%)  5 1/46 (2.17%)  1 1/44 (2.27%)  1 3/52 (5.77%)  3
Blood Glucose Increased  1  0/49 (0.00%)  0 0/46 (0.00%)  0 0/44 (0.00%)  0 4/52 (7.69%)  4
Musculoskeletal and connective tissue disorders         
Pain in Extremity  1  7/49 (14.29%)  7 4/46 (8.70%)  4 5/44 (11.36%)  5 4/52 (7.69%)  4
Back Pain  1  3/49 (6.12%)  3 5/46 (10.87%)  5 0/44 (0.00%)  0 3/52 (5.77%)  3
Arthralgia  1  4/49 (8.16%)  4 0/46 (0.00%)  0 3/44 (6.82%)  3 1/52 (1.92%)  1
Musculoskeletal pain  1  2/49 (4.08%)  2 3/46 (6.52%)  3 1/44 (2.27%)  1 0/52 (0.00%)  0
Myalgia  1  4/49 (8.16%)  4 0/46 (0.00%)  0 2/44 (4.55%)  2 2/52 (3.85%)  2
Nervous system disorders         
Headache  1  5/49 (10.20%)  5 5/46 (10.87%)  5 5/44 (11.36%)  5 6/52 (11.54%)  6
Dizziness  1  1/49 (2.04%)  1 3/46 (6.52%)  3 7/44 (15.91%)  7 5/52 (9.62%)  5
Psychiatric disorders         
Insomnia  1  2/49 (4.08%)  2 0/46 (0.00%)  0 4/44 (9.09%)  4 2/52 (3.85%)  2
Depression  1  0/49 (0.00%)  0 1/46 (2.17%)  1 4/44 (9.09%)  4 1/52 (1.92%)  1
Respiratory, thoracic and mediastinal disorders         
Epistaxis  1  1/49 (2.04%)  1 3/46 (6.52%)  3 7/44 (15.91%)  7 2/52 (3.85%)  2
Dyspnoea Exertional  1  3/49 (6.12%)  3 2/46 (4.35%)  2 4/44 (9.09%)  4 0/52 (0.00%)  0
Dyspnoea  1  1/49 (2.04%)  1 5/46 (10.87%)  5 1/44 (2.27%)  1 2/52 (3.85%)  2
Oropharyngeal Pain  1  0/49 (0.00%)  0 3/46 (6.52%)  3 0/44 (0.00%)  0 0/52 (0.00%)  0
Cough  1  3/49 (6.12%)  3 2/46 (4.35%)  2 1/44 (2.27%)  1 1/52 (1.92%)  1
Skin and subcutaneous tissue disorders         
Ecchymosis  1  4/49 (8.16%)  4 4/46 (8.70%)  4 4/44 (9.09%)  4 3/52 (5.77%)  3
Pruritus  1  2/49 (4.08%)  2 1/46 (2.17%)  1 4/44 (9.09%)  4 0/52 (0.00%)  0
Vascular disorders         
Hypertension  1  1/49 (2.04%)  1 4/46 (8.70%)  4 1/44 (2.27%)  1 1/52 (1.92%)  1
Hypotension  1  2/49 (4.08%)  2 1/46 (2.17%)  1 2/44 (4.55%)  2 3/52 (5.77%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (9.0)
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 PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented as a joint, multi-center publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Brian Cunningham, MD
Organization: Tallikut Pharmaceuticals, Inc.
Phone: 312-505-0420
EMail: brian@baycitycapital.com
Layout table for additonal information
Responsible Party: Tallikut Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00358826    
Other Study ID Numbers: VIA-2291-01
First Submitted: July 28, 2006
First Posted: August 1, 2006
Results First Submitted: June 15, 2012
Results First Posted: July 23, 2012
Last Update Posted: July 23, 2012