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Augmenting Effects of L-DOPS With Carbidopa and Entacapone

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ClinicalTrials.gov Identifier: NCT00547911
Recruitment Status : Terminated (Study terminated due to contamination droxidopa)
First Posted : October 23, 2007
Results First Posted : July 17, 2014
Last Update Posted : July 17, 2014
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Parkinson Disease
Multiple System Atrophy
Autonomic Nervous System Diseases
Interventions Drug: Droxidopa
Drug: Carbidopa
Drug: Entacapone
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title LDOPS + Placebo; LDOPS + CAR; LDOPS + ENT LDOPS + Placebo; LDOPS + Ent; LDOPS + CAR LDOPS + CAR; LDOPS + Placebo; LDOPS + ENT LDOPS + CAR; LDOPS + ENT; LDOPS + Placebo LDOPS + ENT; LDOPS + Placebo; LDOPS + CAR LDOPS + ENT; LDOPS + CAR; LDOPS + Placebo
Hide Arm/Group Description There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + Placebo, followed by LDOPS + CAR, and lastly LDOPS + ENT. There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + Placebo, followed by LDOPS + ENT, and lastly LDOPS + CAR. There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + CAR, followed by LDOPS + Placebo, and lastly LDOPS + ENT. There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + CAR, followed by LDOPS + ENT, and lastly LDOPS + Placebo. There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + ENT, followed by LDOPS + Placebo, and lastly LDOPS + CAR. There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + ENT, followed by LDOPS + CAR, and lastly LDOPS + Placebo.
Period Title: Overall Study
Started 2 2 2 2 3 3
Completed 2 2 2 1 3 3
Not Completed 0 0 0 1 0 0
Reason Not Completed
Adverse Event             0             0             0             1             0             0
Arm/Group Title Healthy Volunteer Pure Autonomic Failure Multiple System Atrophy Parkinson's Disease Total
Hide Arm/Group Description Subjects in good general health Subjects with Pure Autonomic Failure Subjects with autonomic failure and a history of Multiple System Atrophy Subjects with autonomic failure and a history of Parkinson's Disease Total of all reporting groups
Overall Number of Baseline Participants 2 7 2 3 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants 7 participants 2 participants 3 participants 14 participants
53.5  (1.5) 68.6  (8.1) 57.0  (0) 65.0  (7.1) 64.0  (8.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 7 participants 2 participants 3 participants 14 participants
Female
0
   0.0%
2
  28.6%
1
  50.0%
1
  33.3%
4
  28.6%
Male
2
 100.0%
5
  71.4%
1
  50.0%
2
  66.7%
10
  71.4%
1.Primary Outcome
Title Plasma LDOPS Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
Hide Description Blood samples were obtained at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, 24 hours, and 48 hours to assess plasma droxidopa (LDOPS) concentrations.
Time Frame Up to 48 hours after receiving drug(s)
Hide Outcome Measure Data
Hide Analysis Population Description
Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the “Limitations and Caveats” section. In addition, some subject data was unable to be analyzed due to unreliable measurements.
Arm/Group Title LDOPS + Placebo LDOPS + CAR LDOPS + ENT
Hide Arm/Group Description:
Orally received 400 mg of droxidopa after 200 mg of placebo
Orally received 400 mg of droxidopa after 200 mg of carbidopa
Orally received 400 mg of droxidopa after 200 mg of entacapone
Overall Number of Participants Analyzed 13 13 14
Mean (Standard Error)
Unit of Measure: nmol/L
Baseline 0  (0) 0.003  (0.003) 0.897  (0.753)
1 Hour 2246  (611) 1731  (440) 2068  (413)
2 Hour 7067  (1955) 7077  (1324) 9114  (1962)
3 Hour 8695  (1659) 9059  (1447) 12008  (2294)
6 Hour 6843  (1080) 7242  (1749) 7172  (891)
24 Hour 211  (103) 188  (51) 331  (203)
48 Hour 8  (4) 7  (2) 6  (1)
2.Primary Outcome
Title Plasma Norepinephrine Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
Hide Description Blood samples were obtained at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, 24 hours, and 48 hours to assess plasma norepinephrine concentrations.
Time Frame Up to 48 hours after receiving drug(s)
Hide Outcome Measure Data
Hide Analysis Population Description
Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the “Limitations and Caveats” section. In addition, some subject data was unable to be analyzed due to unreliable measurements.
Arm/Group Title LDOPS + Placebo LDOPS + CAR LDOPS + ENT
Hide Arm/Group Description:
Orally received 400 mg of droxidopa after 200 mg of placebo
Orally received 400 mg of droxidopa after 200 mg of carbidopa
Orally received 400 mg of droxidopa after 200 mg of carbidopa
Overall Number of Participants Analyzed 13 13 14
Mean (Standard Error)
Unit of Measure: nmol/L
Baseline 0.87  (0.19) 0.85  (0.15) 1.08  (0.23)
1 Hour 0.89  (0.14) 0.87  (0.16) 1.06  (0.16)
2 Hour 1.17  (0.15) 0.98  (0.19) 1.49  (0.16)
3 Hour 1.27  (0.15) 1.12  (0.19) 1.69  (0.16)
6 Hour 1.26  (0.18) 0.98  (0.19) 1.62  (0.13)
24 Hour 0.85  (0.16) 0.89  (0.15) 1.09  (0.19)
48 Hour 0.70  (0.13) 0.85  (0.16) 0.84  (0.15)
3.Primary Outcome
Title Plasma DHMA Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
Hide Description Blood samples were obtained at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, 24 hours, and 48 hours to assess plasma droxymandelic acid (DHMA) concentrations.
Time Frame Up to 48 hours after receiving drug(s)
Hide Outcome Measure Data
Hide Analysis Population Description
Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the “Limitations and Caveats” section. In addition, some subject data was unable to be analyzed due to unreliable measurements.
Arm/Group Title LDOPS + Placebo LDOPS + CAR LDOPS + ENT
Hide Arm/Group Description:
Orally received 400 mg of droxidopa after 200 mg of placebo
Orally received 400 mg of droxidopa after 200 mg of carbidopa
Orally received 400 mg of droxidopa after 200 mg of entacapone
Overall Number of Participants Analyzed 13 9 11
Mean (Standard Error)
Unit of Measure: nmol/L
Baseline 0.1  (0.1) 1.66  (0.48) 0.97  (0.40)
1 Hour 4.0  (1.0) 2.54  (0.49) 4.58  (1.37)
2 Hour 10.1  (5.7) 1.52  (0.49) 15.04  (3.76)
3 Hour 11.0  (5.1) 1.70  (0.28) 19.91  (4.59)
6 Hour 15.7  (4.3) 1.74  (0.33) 33.03  (10.91)
24 Hour 1.4  (0.8) 3.24  (0.54) 2.21  (1.11)
48 Hour 0.9  (0.4) 3.00  (0.58) 0.90  (0.47)
4.Primary Outcome
Title Plasma DHPG Concentrations After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
Hide Description Blood samples were obtained at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, 24 hours, and 48 hours to assess plasma dihydroxyphenylglycol (DHPG) concentrations.
Time Frame Up to 48 hours after receiving drug(s)
Hide Outcome Measure Data
Hide Analysis Population Description
Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the “Limitations and Caveats” section. In addition, some subject data was unable to be analyzed due to unreliable measurements.
Arm/Group Title LDOPS + Placebo LDOPS + CAR LDOPS + ENT
Hide Arm/Group Description:
Orally received 400 mg of droxidopa after 200 mg of placebo
Orally received 400 mg of droxidopa after 200 mg of placebo
Orally received 400 mg of droxidopa after 200 mg of entacapone
Overall Number of Participants Analyzed 13 14 14
Mean (Standard Error)
Unit of Measure: nmol/L
Baseline 3.4  (0.4) 3.4  (0.4) 3.5  (0.3)
1 Hour 4.1  (0.6) 3.5  (0.4) 8.0  (1.2)
2 Hour 5.4  (0.9) 3.3  (0.5) 16.6  (2.3)
3 Hour 6.1  (0.8) 3.6  (0.6) 19.3  (3.2)
6 Hour 5.7  (0.8) 3.5  (0.8) 10.7  (1.6)
24 Hour 3.4  (0.5) 3.8  (0.4) 4.1  (0.4)
48 Hour 3.4  (0.4) 3.7  (0.5) 3.8  (0.3)
5.Secondary Outcome
Title Systolic Blood Pressures After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
Hide Description Systolic blood pressure was assessed at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, and 24 hours.
Time Frame Up to 24 hours after receiving drug(s)
Hide Outcome Measure Data
Hide Analysis Population Description
Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the “Limitations and Caveats” section. In addition, some subject data was unable to be analyzed due to unreliable measurements.
Arm/Group Title LDOPS + Placebo LDOPS + CAR LDOPS + ENT
Hide Arm/Group Description:
Orally received 400 mg of droxidopa after 200 mg of placebo
Orally received 400 mg of droxidopa after 200 mg of carbidopa
Orally received 400 mg of droxidopa after 200 mg of entacapone
Overall Number of Participants Analyzed 13 14 13
Mean (Standard Error)
Unit of Measure: mmHg
Baseline 140  (7) 143  (6) 139  (5)
1 Hour 148  (8) 144  (7) 149  (8)
2 Hour 163  (10) 144  (11) 158  (10)
3 Hour 165  (10) 148  (8) 161  (12)
6 Hour 161  (9) 146  (8) 159  (9)
24 Hour 149  (7) 143  (6) 144  (7)
6.Secondary Outcome
Title Diastolic Blood Pressures After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
Hide Description Diastolic blood pressure was assessed at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, and 24 hours.
Time Frame Up to 24 hours after receiving drug(s)
Hide Outcome Measure Data
Hide Analysis Population Description
Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the “Limitations and Caveats” section. In addition, some subject data was unable to be analyzed due to unreliable measurements.
Arm/Group Title LDOPS + Placebo LDOPS + CAR LDOPS + ENT
Hide Arm/Group Description:
Orally received 400 mg of droxidopa after 200 mg of placebo
Orally received 400 mg of droxidopa after 200 mg of carbidopa
Orally received 400 mg of droxidopa after 200 mg of entacapone
Overall Number of Participants Analyzed 13 14 13
Mean (Standard Error)
Unit of Measure: mmHg
Baseline 80  (4) 81  (4) 78  (4)
1 Hour 85  (5) 80  (5) 85  (5)
2 Hour 86  (6) 81  (6) 91  (5)
3 Hour 88  (7) 84  (5) 91  (6)
6 Hour 89  (5) 82  (5) 89  (5)
24 Hour 84  (3) 81  (4) 81  (3)
7.Secondary Outcome
Title Heart Rate After 400 mg of Droxidopa + 200 mg of Either Placebo, Carbidopa, or Entacapone
Hide Description Heart rate was assessed at baseline and after drug administration at 1 hour, 2 hours, 3 hours, 6 hours, and 24 hours.
Time Frame Up to 24 hours after receiving drug(s)
Hide Outcome Measure Data
Hide Analysis Population Description
Data for Healthy Volunteers and all Patient groups was combined for analysis due to the low N-value because of premature study termination, which is further described in the “Limitations and Caveats” section. In addition, some subject data was unable to be analyzed due to unreliable measurements.
Arm/Group Title LDOPS + Placebo LDOPS + CAR LDOPS + ENT
Hide Arm/Group Description:
Orally received 400 mg of droxidopa after 200 mg of placebo
Orally received 400 mg of droxidopa after 200 mg of carbidopa
Orally received 400 mg of droxidopa after 200 mg of entacapone
Overall Number of Participants Analyzed 13 14 14
Mean (Standard Error)
Unit of Measure: BPM
Baseline 67  (3) 66  (3) 67  (3)
1 Hour 65  (3) 68  (4) 65  (2)
2 Hour 66  (3) 65  (3) 65  (3)
3 Hour 68  (4) 64  (3) 64  (3)
6 Hour 67  (4) 62  (2) 67  (2)
24 Hour 66  (3) 66  (3) 68  (4)
Time Frame Duration of the study
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LDOPS + Placebo; LDOPS + CAR; LDOPS + ENT LDOPS + Placebo; LDOPS + Ent; LDOPS + CAR LDOPS + CAR; LDOPS + Placebo; LDOPS + ENT LDOPS + CAR; LDOPS + ENT; LDOPS + Placebo LDOPS + ENT; LDOPS + Placebo; LDOPS + CAR LDOPS + ENT; LDOPS + CAR; LDOPS + Placebo
Hide Arm/Group Description There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + Placebo, followed by LDOPS + CAR, and lastly LDOPS + ENT. There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + Placebo, followed by LDOPS + ENT, and lastly LDOPS + CAR. There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + CAR, followed by LDOPS + Placebo, and lastly LDOPS + ENT. There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + CAR, followed by LDOPS + ENT, and lastly LDOPS + Placebo. There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + ENT, followed by LDOPS + Placebo, and lastly LDOPS + CAR. There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + ENT, followed by LDOPS + CAR, and lastly LDOPS + Placebo.
All-Cause Mortality
LDOPS + Placebo; LDOPS + CAR; LDOPS + ENT LDOPS + Placebo; LDOPS + Ent; LDOPS + CAR LDOPS + CAR; LDOPS + Placebo; LDOPS + ENT LDOPS + CAR; LDOPS + ENT; LDOPS + Placebo LDOPS + ENT; LDOPS + Placebo; LDOPS + CAR LDOPS + ENT; LDOPS + CAR; LDOPS + Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
LDOPS + Placebo; LDOPS + CAR; LDOPS + ENT LDOPS + Placebo; LDOPS + Ent; LDOPS + CAR LDOPS + CAR; LDOPS + Placebo; LDOPS + ENT LDOPS + CAR; LDOPS + ENT; LDOPS + Placebo LDOPS + ENT; LDOPS + Placebo; LDOPS + CAR LDOPS + ENT; LDOPS + CAR; LDOPS + Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/2 (0.00%)   0/2 (0.00%)   1/2 (50.00%)   0/3 (0.00%)   0/3 (0.00%) 
Blood and lymphatic system disorders             
Deep Vein Thrombosis followed by Pulmonary Embolism * [1]  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  0/3 (0.00%) 
*
Indicates events were collected by non-systematic assessment
[1]
Subject experienced SAE while at home after receiving the LDOPS + CAR and LDOPS + ENT but before receiving the LDOPS + Placebo. Subject was discontinued from protocol and it was determined that the SAE was unlikely due to any study procedures.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
LDOPS + Placebo; LDOPS + CAR; LDOPS + ENT LDOPS + Placebo; LDOPS + Ent; LDOPS + CAR LDOPS + CAR; LDOPS + Placebo; LDOPS + ENT LDOPS + CAR; LDOPS + ENT; LDOPS + Placebo LDOPS + ENT; LDOPS + Placebo; LDOPS + CAR LDOPS + ENT; LDOPS + CAR; LDOPS + Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/2 (0.00%)   0/2 (0.00%)   0/2 (0.00%)   0/3 (0.00%)   0/3 (0.00%) 
Study was prematurely terminated due to a small amount of DOPAL contamination in the droxidopa. Because of the early termination only a small number of subjects were enrolled in each condition. Recently, the FDA has approved droxidopa.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. David Goldstein
Organization: National Institutes of Health
Phone: 301-496-1115
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
ClinicalTrials.gov Identifier: NCT00547911     History of Changes
Other Study ID Numbers: 080012
08-N-0012 ( Other Identifier: NIH )
First Submitted: October 19, 2007
First Posted: October 23, 2007
Results First Submitted: June 17, 2014
Results First Posted: July 17, 2014
Last Update Posted: July 17, 2014