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Eslicarbazepine Acetate Monotherapy Long Term Study

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: NCT00910247
Recruitment Status : Completed
First Posted : May 29, 2009
Results First Posted : July 17, 2018
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Sunovion

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Epilepsy
Intervention Drug: Eslicarbazepine acetate
Enrollment 274
Recruitment Details Subjects that participated in either study 093-045NCT00866775) or study 093-046(NCT01091662) were eligible to participate in study 093-050
Pre-assignment Details Subjects who completed the 18-week treatment period or exited the study per protocol may be eligible to participate. Subjects who discontinued for reasons other than reaching the exit criteria may be eligible if there is no safety concern, however, subjects must have completed at least the first 3 weeks of the 18-week double-blind treatment
Arm/Group Title Eslicarbazepine Acetate
Hide Arm/Group Description

Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD

Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)

Period Title: Overall Study
Started 274
Completed 205
Not Completed 69
Reason Not Completed
Adverse Event             15
Death             2
Lost to Follow-up             10
Physician Decision             3
Protocol Violation             10
Withdrawal by Subject             25
Not collected             4
Arm/Group Title Eslicarbazepine Acetate
Hide Arm/Group Description

Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD

Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)

Overall Number of Baseline Participants 274
Hide Baseline Analysis Population Description
full analysis set
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 274 participants
<=18 years
12
   4.4%
Between 18 and 65 years
258
  94.2%
>=65 years
4
   1.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 274 participants
37.9  (12.70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 274 participants
Female
134
  48.9%
Male
140
  51.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 274 participants
Hispanic or Latino
28
  10.2%
Not Hispanic or Latino
246
  89.8%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 274 participants
American Indian or Alaska Native
2
   0.7%
Asian
5
   1.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
22
   8.0%
White
229
  83.6%
More than one race
2
   0.7%
Unknown or Not Reported
14
   5.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 274 participants
Canada 3
United States 167
Czechia 27
Ukraine 57
Bulgaria 18
Serbia 2
1.Primary Outcome
Title Number and Percent of Subjects With Treatment Emergent Adverse Events
Hide Description Number and percent of subjects with treatment emergent adverse events
Time Frame One year
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to -Treat (ITT) population consisted of all subjects who had taken any open-label study medication
Arm/Group Title Eslicarbazepine Acetate
Hide Arm/Group Description:

Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD

Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)

Overall Number of Participants Analyzed 274
Measure Type: Count of Participants
Unit of Measure: Participants
220
  80.3%
2.Secondary Outcome
Title Number and Percentage of Subjects With Potentially Clinically Significant Clinical Laboratory Evaluations
Hide Description Number and percentage of subjects with potentially clinically significant clinical laboratory evaluations
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population consisted of all subjects who have taken any open-label study medication.
Arm/Group Title Eslicarbazepine Acetate
Hide Arm/Group Description:

Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD

Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)

Overall Number of Participants Analyzed 274
Measure Type: Count of Participants
Unit of Measure: Participants
186
  67.9%
3.Secondary Outcome
Title Number and Percent of Subjects With Normal Baseline Sodium Reaching Blood Sodium ≤135 mmol/L, ≤130 mmol/L, and ≤125 mmol/L
Hide Description Number and percentage of subjects who had normal sodium value (i.e. >135 mEq/L) at baseline but reached <=135 mEq/L and >130 mEq/L, <=130 mEq/L and >125 mEq/L, or <=125 mEq/L at any post baseline.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
ITT subjects with baseline sodium and at least one post baseline sodium value
Arm/Group Title Eslicarbazepine Acetate
Hide Arm/Group Description:

Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD

Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)

Overall Number of Participants Analyzed 261
Measure Type: Count of Participants
Unit of Measure: Participants
<=135 mEq/L and >130 mEq/L
48
  18.4%
<=130 mEq/L and >125 mEq/L
22
   8.4%
<=125 mEq/L
4
   1.5%
4.Secondary Outcome
Title Percentage of Subjects With Increase of Body Weight ≥7%
Hide Description Percentage of subjects with increase of body weight ≥7%
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population consisted of all subjects who have taken any open-label study medication.
Arm/Group Title Eslicarbazepine Acetate
Hide Arm/Group Description:

Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD

Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)

Overall Number of Participants Analyzed 274
Measure Type: Number
Unit of Measure: percentagae of participants
27
5.Secondary Outcome
Title Number and Percentage of Subjects With Orthostatic Effects.
Hide Description Number and percentage of subjects with orthostatic effects.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population consisted of all subjects who have taken any open-label study medication.
Arm/Group Title Eslicarbazepine Acetate
Hide Arm/Group Description:

Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD

Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)

Overall Number of Participants Analyzed 274
Measure Type: Count of Participants
Unit of Measure: Participants
67
  24.5%
6.Secondary Outcome
Title Number and Percentage of Subjects With QTc-F Changes (in Categories) From Baseline.
Hide Description

Number and percentage of subjects by QT interval corrected using the Fridericia fomula (QTcF) categories

Based on the numbers of subjects who had at least one post-baseline assessment, the number and percentage of subjects with QTcF values in the following categories were summarized:

  1. >500 millisecond (msec) at any post-baseline timepoint but not present at baseline
  2. >480 msec at any post-baseline timepoint but not present at baseline
  3. >450 msec at any post-baseline timepoint but not present at baseline
  4. Change from Baseline >=60 ms for at least one post-baseline measurement
  5. Change from Baseline >=30 ms for at least one post-baseline measurement and <60 ms for all post-baseline measurement

QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle.

Time Frame Baseline, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) subjects with at least one post-baseline assessment
Arm/Group Title Eslicarbazepine Acetate
Hide Arm/Group Description:

Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD

Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)

Overall Number of Participants Analyzed 272
Measure Type: Count of Participants
Unit of Measure: Participants
>500ms at any postbaseline not present at baseli
0
   0.0%
>450ms at any postbaseline not present at baseline
9
   3.3%
>480ms at any postbaseline not present at baseline
1
   0.4%
CFB >=60 ms for at least one post-baseline
0
   0.0%
CFB>=30ms for at least one &<60ms for all PBL
42
  15.4%
7.Secondary Outcome
Title Percentage of Events in Each Classification of the Columbia Suicide Severity Rating Scale (C SSRS).
Hide Description

The C-SSRS is an instrument designed to systematically assess and track suicidal behavior and suicidal ideation. The C-SSRS will be completed by the Investigator or Sub-Investigator (or qualified site personnel).

Suicidal ideation is collected as any occurrence of wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intent to act, active suicidal ideation with some intent to act, without specific plan, active suicidal ideation with specific plan and intent.

Suicidal behavior is collected as any occurrence of actual attempts, Non-Suicidal Self-Injurious Behavior, interrupted attempts, aborted attempts, or preparatory acts or behavior, suicidal behavior.

Any suicidality is defined as having at least one occurrence of Suicidal Behavior or Suicidal Ideation.

Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) population consisted of all subjects that received any open-label study medication
Arm/Group Title Eslicarbazepine Acetate
Hide Arm/Group Description:

Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD

Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)

Overall Number of Participants Analyzed 274
Measure Type: Number
Unit of Measure: percentage of events
Any Suicidality 4.0
Any suicidal behavior 0.7
Any suicidal ideation 3.6
8.Secondary Outcome
Title Time on Eslicarbazepine Acetate Monotherapy.
Hide Description The start of the monotherapy period was defined as the date of termination of all other anti-epileptic drugs while taking study medication. Time on eslicarbazepine acetate monotherapy is defined from the date of the first monotherapy dose in 093-045 or 093-046 study to the last known dose of monotherapy treatment, regardless of dose change and the time gap between the parent studies and the current study.
Time Frame One year
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Subjects who started the monotherapy period (Visit 6/Week 8) in 093-045 or 093-046 and did not add a non-rescue/emergency Antiepileptic drug (AED) during the start date of the monotherapy period
Arm/Group Title Eslicarbazepine Acetate
Hide Arm/Group Description:

Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD

Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)

Overall Number of Participants Analyzed 238
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(NA to NA)
[1]
Median not calculable due to lack of events
9.Secondary Outcome
Title Change in Seizure Frequency From Baseline.
Hide Description Relative (%) change in standard seizure frequency(SSF) from baseline
Time Frame Month 12 from baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population consisted of all subjects who had taken any open-label study medication
Arm/Group Title Eslicarbazepine Acetate
Hide Arm/Group Description:

Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD

Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)

Overall Number of Participants Analyzed 274
Median (Inter-Quartile Range)
Unit of Measure: percent change
-66.4
(-88.8 to -32.3)
10.Secondary Outcome
Title Responder Rate (Percentage of Subjects With a ≥50% Reduction of Seizure Frequency From Baseline).
Hide Description Responder rate (percentage of subjects with a ≥50% reduction of seizure frequency from baseline).
Time Frame One year
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population consisted of all subjects who have taken any open-label study medication.
Arm/Group Title Eslicarbazepine Acetate
Hide Arm/Group Description:

Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD

Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)

Overall Number of Participants Analyzed 274
Measure Type: Number
Unit of Measure: percentage of participants
62.4
11.Secondary Outcome
Title Percentage of Subjects That Are Seizure-free During Study
Hide Description Percentage of subjects that are seizure-free during study
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population consisted of all subjects who have taken any open-label study medication.
Arm/Group Title Eslicarbazepine Acetate
Hide Arm/Group Description:

Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD

Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)

Overall Number of Participants Analyzed 274
Measure Type: Number
Unit of Measure: percentage of participants
7.3
12.Secondary Outcome
Title Completion Rate (% of Subjects Completing the One Year Treatment)
Hide Description Completion rate (% of subjects completing the one year treatment)
Time Frame One year
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population consisted of all subjects who have taken any open-label study medication.
Arm/Group Title Eslicarbazepine Acetate
Hide Arm/Group Description:

Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD

Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)

Overall Number of Participants Analyzed 274
Measure Type: Number
Unit of Measure: percentagae of participants
74.8
13.Secondary Outcome
Title Treatment Retention Time (Time to Withdrawal Due to Lack of Efficacy or Adverse Events)
Hide Description The retention time is defined from the start of eslicarbazepine acetate monotherapy period in 093-045 or 093-046 to the last known dose of open-label eslicarbazepine acetate. The time may include taking eslicarbazepine acetate concomitantly with other anti-epileptic drugs. If a subject's termination reason(s) includes: withdrawal of consent, lost to follow-up, physician decision or other, then it was assumed the subject terminated the study due to lack of efficacy.
Time Frame One year
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) subjects who started the monotherapy period in 093-045 or 093-046 (visi t6/week 8)
Arm/Group Title Eslicarbazepine Acetate
Hide Arm/Group Description:

Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD

Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)

Overall Number of Participants Analyzed 255
Median (95% Confidence Interval)
Unit of Measure: days
NA [1] 
(NA to NA)
[1]
Median time in Days is NA so the 95% CI cannot be calculated since median not calculable due to lack of events during the 1 year open-label period.
14.Secondary Outcome
Title Change in Total Score From Baseline in 31-Item Quality of Life in Epilepsy (QOLIE-31).
Hide Description

Change in the overall score from baseline in 31-Item Quality of Life in Epilepsy (QOLIE-31 )

The QOLIE-31 overall score was obtained by using a weighted average of multi-item scale scores. The recorded responses were converted to 0-100 point scales. The mean of the individual item scores in each subgroup were calculated, with higher converted scores reflecting better quality of life.

Time Frame baseline and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population consisted of all subjects who have taken any open-label study medication.
Arm/Group Title Eslicarbazepine Acetate
Hide Arm/Group Description:

Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD

Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)

Overall Number of Participants Analyzed 274
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.6  (15.29)
15.Secondary Outcome
Title Change in Total Score From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS).
Hide Description The total score of MADRS is defined as the sum of all individual item scores. Each of the 10 symptoms of depression on MADRS is measured on a scale of 0 to 6 with 0 representing the lowest severity of the symptom and 6 representing the highest severity.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population consisted of all subjects who have taken any open-label study medication.
Arm/Group Title Eslicarbazepine Acetate
Hide Arm/Group Description:

Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD

Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)

Overall Number of Participants Analyzed 274
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.5  (6.17)
16.Secondary Outcome
Title Change in Total Score From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) in Those Subjects With a MADRS Score of ≥14 at Screening
Hide Description The total score of MADRS is defined as the sum of all individual item scores . Each of the 10 symptoms of depression on MADRS is measured on a scale of 0 to 6 with 0 representing the lowest severity of the symptom and 6 representing the highest severity.
Time Frame baseline and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population consisted of all subjects who have taken any open-label study medication.
Arm/Group Title Eslicarbazepine Acetate
Hide Arm/Group Description:

Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD

Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)

Overall Number of Participants Analyzed 274
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.5  (6.17)
17.Secondary Outcome
Title Completion Rate (% of Subjects Completing Each Visit Post-one Year).
Hide Description Completion rate (% of subjects completing each visit post-one year).
Time Frame post 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) subjects who entered the post - 1- year open -label period.
Arm/Group Title Eslicarbazepine Acetate
Hide Arm/Group Description:

Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD

Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)

Overall Number of Participants Analyzed 198
Measure Type: Number
Unit of Measure: percentagae of participants
66.7
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Eslicarbazepine Acetate
Hide Arm/Group Description

Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD

Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)

All-Cause Mortality
Eslicarbazepine Acetate
Affected / at Risk (%)
Total   2/274 (0.73%)    
Hide Serious Adverse Events
Eslicarbazepine Acetate
Affected / at Risk (%) # Events
Total   32/274 (11.68%)    
Cardiac disorders   
sinus tachycardia  1  1/274 (0.36%)  1
Ear and labyrinth disorders   
vertigo  1  1/274 (0.36%)  1
Gastrointestinal disorders   
abdominal pain upper  1  1/274 (0.36%)  1
colitis  1  1/274 (0.36%)  1
pancreatitis  1  1/274 (0.36%)  1
vomiting  1  1/274 (0.36%)  1
General disorders   
non-cardiac chest pain  1  3/274 (1.09%)  3
irritability  1  1/274 (0.36%)  1
sudden unexplained death in epilepsy  1  1/274 (0.36%)  1
Hepatobiliary disorders   
cholelithiasis obstructive  1  1/274 (0.36%)  1
Infections and infestations   
chronic sinusitis  1  1/274 (0.36%)  1
histoplasmosis  1  1/274 (0.36%)  1
pneumonia  1  1/274 (0.36%)  1
tooth infection  1  1/274 (0.36%)  1
Injury, poisoning and procedural complications   
accidental overdose  1  1/274 (0.36%)  1
collapse of lung  1  1/274 (0.36%)  1
fall  1  1/274 (0.36%)  1
post concussion syndrome  1  1/274 (0.36%)  1
Therapeutic agent toxicity  1  1/274 (0.36%)  1
Investigations   
electroencephalogram  1  1/274 (0.36%)  1
Metabolism and nutrition disorders   
failure to thrive  1  1/274 (0.36%)  1
Musculoskeletal and connective tissue disorders   
arthritis  1  1/274 (0.36%)  1
muscle twitching  1  1/274 (0.36%)  1
Osteoarthritis  1  1/274 (0.36%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
fallopian tube cancer  1  1/274 (0.36%)  1
non-small cel lung cancer metastatic  1  1/274 (0.36%)  1
ovarian cancer  1  1/274 (0.36%)  1
Nervous system disorders   
partial seizures with secondary generalisation  1  7/274 (2.55%)  7
complex partial seizures  1  3/274 (1.09%)  3
simple partial seizures  1  2/274 (0.73%)  2
akathisia  1  1/274 (0.36%)  1
grand mal convulsion  1  1/274 (0.36%)  1
postictal paralysis  1  1/274 (0.36%)  1
status epilepticus  1  1/274 (0.36%)  1
Psychiatric disorders   
depression  1  1/274 (0.36%)  1
suicidal ideation  1  1/274 (0.36%)  1
Renal and urinary disorders   
nephrolithiasis  1  1/274 (0.36%)  1
Respiratory, thoracic and mediastinal disorders   
emphysema  1  1/274 (0.36%)  1
Vascular disorders   
accelerated hypertension  1  1/274 (0.36%)  1
1
Term from vocabulary, MedDRA (13.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Eslicarbazepine Acetate
Affected / at Risk (%) # Events
Total   166/274 (60.58%)    
Gastrointestinal disorders   
nausea  1  24/274 (8.76%)  31
vomiting  1  16/274 (5.84%)  20
diarrhoea  1  15/274 (5.47%)  19
General disorders   
fatigue  1  23/274 (8.39%)  25
Infections and infestations   
nasopharyngitis  1  24/274 (8.76%)  35
influenza  1  14/274 (5.11%)  15
Injury, poisoning and procedural complications   
fall  1  20/274 (7.30%)  33
Musculoskeletal and connective tissue disorders   
back pain  1  16/274 (5.84%)  16
Nervous system disorders   
headache  1  64/274 (23.36%)  144
dizziness  1  46/274 (16.79%)  81
complex partial seizures  1  14/274 (5.11%)  18
Psychiatric disorders   
depression  1  18/274 (6.57%)  19
insomnia  1  15/274 (5.47%)  18
1
Term from vocabulary, MedDRA (13.1)
Indicates events were collected by systematic assessment
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.
In the event the Study is part of a multi-center study, the first publication of the results of the Study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: CNS Medical Director
Organization: Sunovion Pharmaceuticals Inc.
Phone: 1-866-503-6351
EMail: clinicaltrialsdisclosure@sunovion.com
Layout table for additonal information
Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT00910247    
Other Study ID Numbers: 093-050
First Submitted: May 27, 2009
First Posted: May 29, 2009
Results First Submitted: April 13, 2018
Results First Posted: July 17, 2018
Last Update Posted: July 17, 2018