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Dabigatran Etexilate in Patients With Mechanical Heart Valves (RE-ALIGN)

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: NCT01452347
Recruitment Status : Terminated
First Posted : October 14, 2011
Results First Posted : August 6, 2014
Last Update Posted : August 6, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Heart Valve Diseases
Interventions Drug: warfarin 1mg
Drug: dabigatran etexilate intermediate dose
Drug: dabigatran etexilate low dose
Drug: warfarin 5mg
Drug: dabigatran etexilate high dose
Drug: warfarin 3mg
Enrollment 328
Recruitment Details  
Pre-assignment Details 76 patients were not entered/randomized
Arm/Group Title Dabigatran Etexilate (DE) Warfarin
Hide Arm/Group Description Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
Period Title: Overall Study
Started 168 84
Completed 151 77
Not Completed 17 7
Reason Not Completed
Adverse Event             2             1
Non compliance protocol             2             0
Lost to Follow-up             2             0
Withdrawal by Subject             3             3
Not treated             6             3
Other reason not defined above             2             0
Arm/Group Title Dabigatran Etexilate (DE) Warfarin Total
Hide Arm/Group Description Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator Total of all reporting groups
Overall Number of Baseline Participants 162 81 243
Hide Baseline Analysis Population Description
Treated Set (TRT): The set of patients who received at least 1 dose of study medication
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 162 participants 81 participants 243 participants
56.3  (9.2) 55.8  (10.2) 56.2  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 162 participants 81 participants 243 participants
Female
60
  37.0%
26
  32.1%
86
  35.4%
Male
102
  63.0%
55
  67.9%
157
  64.6%
1.Primary Outcome
Title Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations at Steady State (C Trough,ss) at Week 1
Hide Description

Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE) .

Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population.

Time Frame Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS.
Arm/Group Title Observed Predicted
Hide Arm/Group Description:
This includes the observed Ctrough,ss value for all patients in the pharmacokinetic set (PKS) who have a corresponding predicted value.
This includes the predicted Ctrough,ss value for all patients in the PKS who have a corresponding observed value.
Overall Number of Participants Analyzed 130 130
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
73.86
(43.9%)
99.52
(43.9%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Observed, Predicted
Comments

Null hypothesis: "The difference of the population average responses was either ≤ to the lower bound or ≥ to the upper bound of the acceptance range" .

Alternative hypothesis: "The difference of the population average responses was both > than the lower bound and < than the upper bound of the acceptance range" [Note: The acceptance range for the geometric mean is 80-125%]

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments The Ctrough,ss (predicted or observed) was log transformed (natural logarithm) prior to fitting the ANOVA model.
Method of Estimation Estimation Parameter Adjusted Geometric Mean ratio
Estimated Value 74.22
Confidence Interval 95%
68.08 to 80.91
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.05
Estimation Comments

The standard error of the mean is actually the geometric standard error.

(Observed vs Predicted)

2.Primary Outcome
Title Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 2
Hide Description

Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE).

Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population.

Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS.
Arm/Group Title Observed Predicted
Hide Arm/Group Description:
This includes the observed Ctrough,ss value for all patients in the PKS who have a corresponding predicted value.
This includes the predicted Ctrough,ss value for all patients in the PKS who have a corresponding observed value.
Overall Number of Participants Analyzed 26 26
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
84.08
(40.2%)
99.55
(40.2%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Observed, Predicted
Comments

Null hypothesis: "The difference of the population average responses was either ≤ to the lower bound or ≥ to the upper bound of the acceptance range" .

Alternative hypothesis: "The difference of the population average responses was both > than the lower bound and < than the upper bound of the acceptance range" [Note: The acceptance range for the geometric mean is 80-125%]

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments The Ctrough,ss (predicted or observed) was log transformed (natural logarithm) prior to fitting the ANOVA model.
Method of Estimation Estimation Parameter Adjusted Geometric Mean ratio
Estimated Value 84.46
Confidence Interval 95%
70.32 to 101.44
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.11
Estimation Comments

The standard error of the mean is actually the geometric standard error.

(Observed vs Predicted)

3.Primary Outcome
Title Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 4
Hide Description

Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE).

Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population.

Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS.
Arm/Group Title Observed Predicted
Hide Arm/Group Description:
This includes the observed Ctrough,ss value for all patients in the PKS who have a corresponding predicted value.
This includes the predicted Ctrough,ss value for all patients in the PKS who have a corresponding observed value.
Overall Number of Participants Analyzed 112 112
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
104.43
(34.3%)
109.36
(34.3%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Observed, Predicted
Comments

Null hypothesis: "The difference of the population average responses was either ≤ to the lower bound or ≥ to the upper bound of the acceptance range" .

Alternative hypothesis: "The difference of the population average responses was both > than the lower bound and < than the upper bound of the acceptance range" [Note: The acceptance range for the geometric mean is 80-125%]

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments The Ctrough,ss (predicted or observed) was log transformed (natural logarithm) prior to fitting the ANOVA model.
Method of Estimation Estimation Parameter Adjusted Geometric Mean ratio
Estimated Value 95.50
Confidence Interval 95%
88.69 to 102.84
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.05
Estimation Comments

The standard error of the mean is actually the geometric standard error.

(Observed vs Predicted)

4.Primary Outcome
Title Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at End of Trial (EoT) at Week 12
Hide Description

Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE).

(As the trial was stopped prematurely, EOT may not be 12 weeks after randomisation for most of the patients)

Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population.

Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS.
Arm/Group Title Observed Predicted
Hide Arm/Group Description:
This includes the observed Ctrough,ss value for all patients in the PKS who have a corresponding predicted value.
This includes the predicted Ctrough,ss value for all patients in the PKS who have a corresponding observed value.
Overall Number of Participants Analyzed 54 54
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
108.21
(59.8%)
104.80
(59.8%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Observed, Predicted
Comments

Null hypothesis: "The difference of the population average responses was either ≤ to the lower bound or ≥ to the upper bound of the acceptance range" .

Alternative hypothesis: "The difference of the population average responses was both > than the lower bound and < than the upper bound of the acceptance range" [Note: The acceptance range for the geometric mean is 80-125%]

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments The Ctrough,ss (predicted or observed) was log transformed (natural logarithm) prior to fitting the ANOVA model.
Method of Estimation Estimation Parameter Adjusted Geometric Mean ratio
Estimated Value 103.25
Confidence Interval 95%
86.40 to 123.40
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.11
Estimation Comments

The standard error of the mean is actually the geometric standard error.

(Observed vs Predicted)

5.Secondary Outcome
Title Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 1
Hide Description Percentage of patients with observed Ctrough,ss value < 50 ng/mL are presented. This outcome measure was only analysed for all patients together and not by dose group.
Time Frame Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS.
Arm/Group Title Patients Evaluated
Hide Arm/Group Description:
All patients treated orally with either 150mg, 220mg or 300mg of dabigatran etexilate (DE) twice daily.
Overall Number of Participants Analyzed 130
Measure Type: Number
Unit of Measure: percentage of participants
26.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Patients Evaluated
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Probability that P remains < 10% are presented, where P=Percentage of patients with observed Ctrough,ss value < 50 ng/mL
Method Beta Function
Comments Probability calculated using Beta function ~B(1 + r, 1 + n - r),r=no. of patients(observed Ctrough,ss value < 50 ng/mL), n=no. of patients evaluated
6.Secondary Outcome
Title Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 2
Hide Description Percentage of patients with observed Ctrough,ss value < 50 ng/mL are presented. This outcome measure was only analysed for all patients together and not by dose group.
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS.
Arm/Group Title Patients Evaluated
Hide Arm/Group Description:
All patients treated orally with either 150mg, 220mg or 300mg of dabigatran etexilate (DE) twice daily.
Overall Number of Participants Analyzed 26
Measure Type: Number
Unit of Measure: percentage of participants
19.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Patients Evaluated
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments Probability that P remains < 10% are presented, where P=Percentage of patients with observed Ctrough,ss value < 50 ng/mL
Method Beta Function
Comments Probability calculated using Beta function ~B(1 + r, 1 + n - r),r=no. of patients(observed Ctrough,ss value < 50 ng/mL), n=no. of patients evaluated
7.Secondary Outcome
Title Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 4
Hide Description Percentage of patients with observed Ctrough,ss value < 50 ng/mL are presented. This outcome measure was only analysed for all patients together and not by dose group.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS.
Arm/Group Title Patients Evaluated
Hide Arm/Group Description:
All patients treated orally with either 150mg, 220mg or 300mg of dabigatran etexilate (DE) twice daily.
Overall Number of Participants Analyzed 112
Measure Type: Number
Unit of Measure: percentage of participants
9.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Patients Evaluated
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.46
Comments Probability that P remains < 10% are presented, where P=Percentage of patients with observed Ctrough,ss value < 50 ng/mL
Method Beta Function
Comments Probability calculated using Beta function ~B(1 + r, 1 + n - r),r=no. of patients(observed Ctrough,ss value < 50 ng/mL), n=no. of patients evaluated
8.Secondary Outcome
Title Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at End of Trial (EoT) Week 12
Hide Description Percentage of patients with observed Ctrough,ss value < 50 ng/mL (As the trial was stopped prematurely, EOT may not be 12 weeks after randomisation for most of the patients) This outcome measure was only analysed for all patients together and not by dose group.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS.
Arm/Group Title Patients Evaluated
Hide Arm/Group Description:
All patients treated orally with either 150mg, 220mg or 300mg of dabigatran etexilate (DE) twice daily.
Overall Number of Participants Analyzed 54
Measure Type: Number
Unit of Measure: percentage of participants
7.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Patients Evaluated
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.65
Comments Probability that P remains < 10% are presented, where P=Percentage of patients with observed Ctrough,ss value < 50 ng/mL
Method Beta Function
Comments Probability calculated using Beta function ~B(1 + r, 1 + n - r),r=no. of patients(observed Ctrough,ss value < 50 ng/mL), n=no. of patients evaluated
Time Frame From first intake of study drug until last intake of study drug plus 6 days (Up to 101 days).
Adverse Event Reporting Description There were 8 patients who switched from dabigatran etexilate to warfarin during the study, and hence these patients are counted in the denominator of both arms. Any AEs which occurred in these patients are only presented under the treatment that the patient was taking at the time of the event.
 
Arm/Group Title Dabigatran Etexilate Warfarin
Hide Arm/Group Description Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
All-Cause Mortality
Dabigatran Etexilate Warfarin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dabigatran Etexilate Warfarin
Affected / at Risk (%) Affected / at Risk (%)
Total   19/162 (11.73%)   11/89 (12.36%) 
Blood and lymphatic system disorders     
Anaemia  1  1/162 (0.62%)  0/89 (0.00%) 
Cardiac disorders     
Atrial fibrillation  1  5/162 (3.09%)  1/89 (1.12%) 
Pericardial effusion  1  5/162 (3.09%)  0/89 (0.00%) 
Prinzmetal angina  1  0/162 (0.00%)  1/89 (1.12%) 
Cardiac tamponade  1  1/162 (0.62%)  0/89 (0.00%) 
Ventricular dysfunction  1  1/162 (0.62%)  0/89 (0.00%) 
General disorders     
Chest pain  1  0/162 (0.00%)  1/89 (1.12%) 
Impaired healing  1  0/162 (0.00%)  1/89 (1.12%) 
Device malfunction  1  1/162 (0.62%)  0/89 (0.00%) 
Pyrexia  1  1/162 (0.62%)  0/89 (0.00%) 
Infections and infestations     
Wound infection staphylococcal  1  0/162 (0.00%)  1/89 (1.12%) 
Cellulitis  1  1/162 (0.62%)  0/89 (0.00%) 
Endocarditis  1  1/162 (0.62%)  0/89 (0.00%) 
Urinary tract infection  1  1/162 (0.62%)  0/89 (0.00%) 
Viral infection  1  1/162 (0.62%)  0/89 (0.00%) 
Wound infection  1  1/162 (0.62%)  0/89 (0.00%) 
Injury, poisoning and procedural complications     
Wound dehiscence  1  0/162 (0.00%)  1/89 (1.12%) 
Postoperative thoracic procedure complication  1  1/162 (0.62%)  0/89 (0.00%) 
Investigations     
Ejection fraction decreased  1  0/162 (0.00%)  1/89 (1.12%) 
International normalised ratio decreased  1  0/162 (0.00%)  1/89 (1.12%) 
International normalised ratio increased  1  0/162 (0.00%)  1/89 (1.12%) 
C-reactive protein increased  1  1/162 (0.62%)  0/89 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  0/162 (0.00%)  1/89 (1.12%) 
Nervous system disorders     
Loss of consciousness  1  0/162 (0.00%)  1/89 (1.12%) 
Vascular disorders     
Hypertension  1  1/162 (0.62%)  1/89 (1.12%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dabigatran Etexilate Warfarin
Affected / at Risk (%) Affected / at Risk (%)
Total   64/162 (39.51%)   38/89 (42.70%) 
Cardiac disorders     
Atrial fibrillation  1  11/162 (6.79%)  9/89 (10.11%) 
Pericardial effusion  1  8/162 (4.94%)  7/89 (7.87%) 
Gastrointestinal disorders     
Diarrhoea  1  19/162 (11.73%)  2/89 (2.25%) 
Dyspepsia  1  15/162 (9.26%)  0/89 (0.00%) 
Constipation  1  10/162 (6.17%)  7/89 (7.87%) 
Nausea  1  5/162 (3.09%)  5/89 (5.62%) 
General disorders     
Oedema peripheral  1  10/162 (6.17%)  2/89 (2.25%) 
Infections and infestations     
Urinary tract infection  1  5/162 (3.09%)  5/89 (5.62%) 
Nervous system disorders     
Dizziness  1  3/162 (1.85%)  5/89 (5.62%) 
Respiratory, thoracic and mediastinal disorders     
Pleural effusion  1  11/162 (6.79%)  3/89 (3.37%) 
Cough  1  8/162 (4.94%)  6/89 (6.74%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 16.0
This study was terminated prematurely due to safety concerns arising during conduct of the trial.
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.
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01452347     History of Changes
Other Study ID Numbers: 1160.113
2010-022685-27 ( EudraCT Number: EudraCT )
First Submitted: October 11, 2011
First Posted: October 14, 2011
Results First Submitted: May 23, 2014
Results First Posted: August 6, 2014
Last Update Posted: August 6, 2014