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Trial record 42 of 117 for:    DUTASTERIDE

Dutasteride With Tolterodine ER or Placebo to Treat Lower Urinary Tract Symptoms (LUTS) (LUTS)

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ClinicalTrials.gov Identifier: NCT00939120
Recruitment Status : Completed
First Posted : July 14, 2009
Results First Posted : May 1, 2015
Last Update Posted : May 1, 2015
Sponsor:
Collaborators:
GlaxoSmithKline
Pfizer
Information provided by (Responsible Party):
Paul F. Siami, MD, Siami, Paul F., M.D.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Benign Prostatic Hyperplasia (BPH)
Interventions Drug: Tolterodine ER 4mg
Drug: Placebo
Drug: Pre-randomization Dutasteride
Enrollment 46
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tolterodine ER 4mg + Dutasteride 0.5mg Placebo + Dutasteride 0.5mg
Hide Arm/Group Description Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily. Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
Period Title: Overall Study
Started 23 23
Completed 15 18
Not Completed 8 5
Arm/Group Title Tolterodine ER 4mg + Dutasteride 0.5mg Placebo + Dutasteride 0.5mg Total
Hide Arm/Group Description Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily. Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily. Total of all reporting groups
Overall Number of Baseline Participants 23 23 46
Hide Baseline Analysis Population Description
Number of patients randomized into control or experimental groups.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants 23 participants 46 participants
68.6  (9.5) 67.7  (7.4) 68.2  (8.4)
[1]
Measure Description: Age of patient at enrollment
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 23 participants 46 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
23
 100.0%
23
 100.0%
46
 100.0%
[1]
Measure Description: Gender of participant.
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 23 participants 46 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
   4.3%
1
   2.2%
White
23
 100.0%
22
  95.7%
45
  97.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: Race of the participant.
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 23 participants 23 participants 46 participants
23 23 46
[1]
Measure Description: Region in which participant was enrolled.
Prostate volume   [1] 
Mean (Standard Deviation)
Unit of measure:  mL
Number Analyzed 23 participants 23 participants 46 participants
43.9  (15.8) 43.1  (16.0) 43.5  (15.7)
[1]
Measure Description: Prostate volume measured by transrectal ultrasound, age-adjusted for this study.
Prostate specific antigen   [1] 
Mean (Standard Deviation)
Unit of measure:  ng/mL
Number Analyzed 23 participants 23 participants 46 participants
4.0  (2.1) 5.3  (8.8) 4.6  (6.4)
[1]
Measure Description: Prostate specific antigen measured via blood test.
Voided volume   [1] 
Mean (Standard Deviation)
Unit of measure:  mL
Number Analyzed 23 participants 23 participants 46 participants
202.5  (96.5) 273.7  (189.9) 238.1  (153.2)
[1]
Measure Description: Voided urinary volume via uroflowmetry.
Maximum flow rate   [1] 
Mean (Standard Deviation)
Unit of measure:  mL/sec
Number Analyzed 23 participants 23 participants 46 participants
11.1  (3.5) 12.4  (4.8) 11.7  (4.2)
[1]
Measure Description: Maximum urine flow rate (Qmax) measured via uroflowmetry.
Post-void residual volume   [1] 
Mean (Standard Deviation)
Unit of measure:  mL
Number Analyzed 23 participants 23 participants 46 participants
93.0  (69.2) 81.6  (60.7) 87.3  (64.6)
[1]
Measure Description: Post-voiding residual volume (PVR) measured in each participant via ultrasound.
Overactive bladder questionnaire   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 23 participants 23 participants 46 participants
86.4  (22.3) 86.1  (29.9) 86.3  (26.1)
[1]
Measure Description: The Overactive Bladder Questionnaire score is based on the answers to 33 questions concerning bladder symptoms. Each question is assigned points from 1 to 6 indicating increasing severity of the particular symptom. The total score can therefore range from 33 to 198 (asymptomatic to very symptomatic).
Patient's perception of bladder condition   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 23 participants 23 participants 46 participants
3.7  (0.9) 3.7  (1.0) 3.7  (0.9)
[1]
Measure Description: Patient-reported scores on a scale of 1-6 indicating how their bladder condition affects them. Scores are as follows: 1 = Does not cause me any problems at all; 2 = Causes me some very minor problems; 3 = Causes me some minor problems; 4 = Causes me (some) moderate problems; 5 = Causes me severe problems; 6 = Causes me many severe problems.
International prostate symptoms score, total   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 23 participants 23 participants 46 participants
18.0  (6.2) 17.7  (4.5) 17.9  (5.4)
[1]
Measure Description: The IPSS is based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).
International prostate symptoms score, voiding subscore   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 23 participants 23 participants 46 participants
9.1  (4.3) 9.0  (3.8) 9.1  (4.0)
[1]
Measure Description:

The IPSS is based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).

Voiding sub-component is 4/7 questions, thus ranging from 0-20.

International prostate symptoms score, storage subscore   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 23 participants 23 participants 46 participants
8.9  (2.7) 8.7  (2.2) 8.8  (2.4)
[1]
Measure Description:

The IPSS is based on the answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).

Storage sub-component is 3/7 questions, thus ranging from 0-15.

Urinary urgency   [1] 
Mean (Standard Deviation)
Unit of measure:  Urgency episodes
Number Analyzed 23 participants 23 participants 46 participants
6.7  (3.5) 8.6  (3.5) 7.7  (3.6)
[1]
Measure Description: Patient reported number of urgency episodes during a 24-hour period.
Urinary frequency   [1] 
Mean (Standard Deviation)
Unit of measure:  Frequency episodes
Number Analyzed 23 participants 23 participants 46 participants
11.3  (2.2) 11.4  (2.2) 11.3  (2.2)
[1]
Measure Description: Participant reported urinary frequency episodes during a 24-hour period.
1.Primary Outcome
Title Post-void Residual (PVR) Volume
Hide Description To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: post-voiding residual volume measured via ultrasound.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Last data point carried forward for participants who were randomized and dropped prior to study end.
Arm/Group Title Tolterodine ER 4mg + Dutasteride 0.5mg Placebo + Dutasteride 0.5mg
Hide Arm/Group Description:
Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
Overall Number of Participants Analyzed 23 23
Mean (Standard Error)
Unit of Measure: mL
101.7  (22.4) 75.8  (9.6)
2.Primary Outcome
Title Maximum Urine Flow Rate (Qmax).
Hide Description To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: maximum urine flow rate (Qmax) measured via uroflowmetry.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Last data point carried forward for participants who were randomized and dropped prior to study end.
Arm/Group Title Tolterodine ER 4mg + Dutasteride 0.5mg Placebo + Dutasteride 0.5mg
Hide Arm/Group Description:
Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
Overall Number of Participants Analyzed 23 23
Mean (Standard Error)
Unit of Measure: mL/sec
11.7  (0.7) 12.9  (1.7)
3.Primary Outcome
Title Urine Voided Volume (Voiding)
Hide Description To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: urine voided volume (voiding) measured by uroflowmetry.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Last data point carried forward for participants who were randomized and dropped prior to study end.
Arm/Group Title Tolterodine ER 4mg + Dutasteride 0.5mg Placebo + Dutasteride 0.5mg
Hide Arm/Group Description:
Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
Overall Number of Participants Analyzed 23 23
Mean (Standard Error)
Unit of Measure: mL
219.9  (20.6) 232.9  (32.3)
4.Primary Outcome
Title Acute Urinary Retention (AUR)
Hide Description To evaluate the safety of dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with symptoms of LUTS: acute urinary attention (AUR) - inability to urinate requiring catheterization.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Last data point carried forward for participants who were randomized and dropped prior to study end.
Arm/Group Title Tolterodine ER 4mg + Dutasteride 0.5mg Placebo + Dutasteride 0.5mg
Hide Arm/Group Description:
Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
Overall Number of Participants Analyzed 23 23
Measure Type: Number
Unit of Measure: participants
0 0
5.Secondary Outcome
Title Overactive Bladder Questionnaire (OABq)
Hide Description To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: overactive bladder questionnaire (OABq) - 33 questions scored via 1-6 (higher scores indicate more severe symptoms), thus values ranged from 33-198.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Last data point carried forward for participants who were randomized and dropped prior to study end.
Arm/Group Title Tolterodine ER 4mg + Dutasteride 0.5mg Placebo + Dutasteride 0.5mg
Hide Arm/Group Description:
Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
Overall Number of Participants Analyzed 23 23
Mean (Standard Error)
Unit of Measure: units on a scale
80.2  (5.8) 67.7  (5.3)
6.Secondary Outcome
Title Patient Perception of Bladder Condition (PPBC)
Hide Description To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: participant reported patient perception of bladder condition (PPBC), one question scored from 1-6, higher scores indicating more severe symptoms.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Last data point carried forward for participants who were randomized and dropped prior to study end.
Arm/Group Title Tolterodine ER 4mg + Dutasteride 0.5mg Placebo + Dutasteride 0.5mg
Hide Arm/Group Description:
Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
Overall Number of Participants Analyzed 23 23
Mean (Standard Error)
Unit of Measure: units on a scale
3.6  (0.3) 3.0  (0.2)
7.Secondary Outcome
Title International Prostate Symptoms Score (IPSS), Total
Hide Description To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: total international prostate symptoms score (IPSS) - 7 questions scored from 0-5 (higher score indicating more severe symptoms), thus total scores ranged from 0-35.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Last data point carried forward for participants who were randomized and dropped prior to study end.
Arm/Group Title Tolterodine ER 4mg + Dutasteride 0.5mg Placebo + Dutasteride 0.5mg
Hide Arm/Group Description:
Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
Overall Number of Participants Analyzed 23 23
Mean (Standard Error)
Unit of Measure: units on a scale
15.4  (1.4) 14.5  (1.3)
8.Secondary Outcome
Title International Prostate Symptoms Score, Voiding Subscore
Hide Description To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: voiding subscore of international prostate symptoms score (IPSS) - 4 questions scored from 0-5 (higher score indicating more severe symptoms), thus total scores ranged from 0-20.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Last data point carried forward for participants who were randomized and dropped prior to study end.
Arm/Group Title Tolterodine ER 4mg + Dutasteride 0.5mg Placebo + Dutasteride 0.5mg
Hide Arm/Group Description:
Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
Overall Number of Participants Analyzed 23 23
Mean (Standard Error)
Unit of Measure: units on a scale
7.5  (1.0) 7.0  (0.9)
9.Secondary Outcome
Title International Prostate Symptoms Score (IPSS), Storage Subscore
Hide Description To evaluate the efficacy in men taking dutasteride 0.5 mg in combination with either tolterodine ER 4mg or placebo for the treatment of men with LUTS including OAB symptoms: storage subscore international prostate symptoms score (IPSS) - 3 questions scored from 0-5 (higher score indicating more severe symptoms), thus total scores ranged from 0-15.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Last data point carried forward for participants who were randomized and dropped prior to study end.
Arm/Group Title Tolterodine ER 4mg + Dutasteride 0.5mg Placebo + Dutasteride 0.5mg
Hide Arm/Group Description:
Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
Overall Number of Participants Analyzed 23 23
Mean (Standard Error)
Unit of Measure: units on a scale
7.9  (0.7) 7.5  (0.6)
Time Frame 19 months.
Adverse Event Reporting Description Reported all adverse events broken up based on categorization as adverse event, serious adverse event, and possibly drug-related adverse event.
 
Arm/Group Title Tolterodine ER 4mg + Dutasteride 0.5mg Placebo + Dutasteride 0.5mg
Hide Arm/Group Description Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily. Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
All-Cause Mortality
Tolterodine ER 4mg + Dutasteride 0.5mg Placebo + Dutasteride 0.5mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Tolterodine ER 4mg + Dutasteride 0.5mg Placebo + Dutasteride 0.5mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/23 (17.39%)      5/23 (21.74%)    
Cardiac disorders     
Atrial fibrillation  [1]  1/23 (4.35%)  1 0/23 (0.00%)  0
Gastrointestinal disorders     
Oral thrush  [2]  0/23 (0.00%)  0 1/23 (4.35%)  1
Schatzki ring  [3]  0/23 (0.00%)  0 1/23 (4.35%)  1
Presbyesophagus, dysphagia  [4]  0/23 (0.00%)  0 1/23 (4.35%)  1
Hiatal hernia  [5]  0/23 (0.00%)  0 1/23 (4.35%)  1
Gastropathy  [2]  0/23 (0.00%)  0 1/23 (4.35%)  1
Hepatobiliary disorders     
Gallstones  [6]  0/23 (0.00%)  0 1/23 (4.35%)  1
Musculoskeletal and connective tissue disorders     
Osteoarthritis  [7]  1/23 (4.35%)  1 0/23 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Mass on kidney  [8]  0/23 (0.00%)  0 1/23 (4.35%)  1
Nervous system disorders     
Transient ischemic attacks  [9]  1/23 (4.35%)  1 0/23 (0.00%)  0
Cervical stenosis  [10]  0/23 (0.00%)  0 1/23 (4.35%)  1
Psychiatric disorders     
Depression  [11]  0/23 (0.00%)  0 1/23 (4.35%)  1
Suicidal self-inflicted gunshot wound, lethal   0/23 (0.00%)  0 1/23 (4.35%)  1
Renal and urinary disorders     
Kidney stone  [10]  1/23 (4.35%)  1 0/23 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Nasal airway obstruction  [12]  0/23 (0.00%)  0 1/23 (4.35%)  1
Indicates events were collected by systematic assessment
[1]
Mild intensity
[2]
Mild
[3]
Mild, continuous, shallow
[4]
Moderate to severe
[5]
Mild, continuous
[6]
Severe, requiring cholecystectomy
[7]
Moderate intermittent exacerbation
[8]
Severe, continuous.
[9]
Moderate, intermittent
[10]
Severe
[11]
Severe, continuous
[12]
Bilateral, moderate intensity.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tolterodine ER 4mg + Dutasteride 0.5mg Placebo + Dutasteride 0.5mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/23 (91.30%)      22/23 (95.65%)    
Blood and lymphatic system disorders     
Epistaxis   2/23 (8.70%)  0/23 (0.00%) 
Cardiac disorders     
Atrial fibrillation   2/23 (8.70%)  0/23 (0.00%) 
Angina   0/23 (0.00%)  2/23 (8.70%) 
Ear and labyrinth disorders     
Otitis media   2/23 (8.70%)  1/23 (4.35%) 
Endocrine disorders     
Diabetes   1/23 (4.35%)  2/23 (8.70%) 
Eye disorders     
Cataracts  [1]  0/23 (0.00%)  3/23 (13.04%) 
Gastrointestinal disorders     
Abdominal pain   0/23 (0.00%)  5/23 (21.74%) 
General disorders     
Fatigue   2/23 (8.70%)  2/23 (8.70%) 
Metabolism and nutrition disorders     
Hyperlipidemia   1/23 (4.35%)  2/23 (8.70%) 
Musculoskeletal and connective tissue disorders     
Plantar fasciitis   1/23 (4.35%)  4/23 (17.39%) 
Osteoarthritis   2/23 (8.70%)  2/23 (8.70%) 
Back pain   1/23 (4.35%)  3/23 (13.04%) 
Nervous system disorders     
Headache   0/23 (0.00%)  3/23 (13.04%) 
Renal and urinary disorders     
Difficulty urinating   3/23 (13.04%)  2/23 (8.70%) 
Urinary urgency / incontinence   5/23 (21.74%)  2/23 (8.70%) 
Kidney stones   0/23 (0.00%)  2/23 (8.70%) 
Urinary frequency   2/23 (8.70%)  0/23 (0.00%) 
Reproductive system and breast disorders     
Increase in prostate specific antigen   2/23 (8.70%)  0/23 (0.00%) 
Prostate nodule   2/23 (8.70%)  0/23 (0.00%) 
Groin pain   2/23 (8.70%)  0/23 (0.00%) 
Erectile dysfunction   2/23 (8.70%)  0/23 (0.00%) 
Gynecomastia   1/23 (4.35%)  3/23 (13.04%) 
Breast tenderness   4/23 (17.39%)  1/23 (4.35%) 
Respiratory, thoracic and mediastinal disorders     
URI / sinusitis / rhinitis   8/23 (34.78%)  12/23 (52.17%) 
Bronchitis / pneumonia   4/23 (17.39%)  4/23 (17.39%) 
Cough   5/23 (21.74%)  2/23 (8.70%) 
Skin and subcutaneous tissue disorders     
Actinic keratosis, basal cell carcinoma   3/23 (13.04%)  1/23 (4.35%) 
Dermatitis   2/23 (8.70%)  1/23 (4.35%) 
Indicates events were collected by systematic assessment
[1]
Incidence and surgery of cataracts
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: Dr. Paul Siami
Organization: Research institute at Deaconess Clinic
Phone: 812-426-9548
EMail: paul.siami@deaconess.com
Layout table for additonal information
Responsible Party: Paul F. Siami, MD, Siami, Paul F., M.D.
ClinicalTrials.gov Identifier: NCT00939120     History of Changes
Other Study ID Numbers: 110983
First Submitted: June 12, 2009
First Posted: July 14, 2009
Results First Submitted: March 16, 2015
Results First Posted: May 1, 2015
Last Update Posted: May 1, 2015