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Trial record 15 of 110 for:    nrp 104 OR lisdexamfetamine

Lisdexamfetamine Dimesylate 2-year Safety Study in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)

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ClinicalTrials.gov Identifier: NCT01328756
Recruitment Status : Completed
First Posted : April 5, 2011
Results First Posted : August 6, 2015
Last Update Posted : August 6, 2015
Sponsor:
Information provided by (Responsible Party):
Shire

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition Attention Deficit Hyperactivity Disorder (ADHD)
Intervention Drug: Lisdexamfetamine dimesylate
Enrollment 314
Recruitment Details This study enrolled participants from 3 antecedent studies (SPD489-317 [NCT01106430], SPD489-325 [NCT00763971], and SPD489-326 [NCT00784654]), or directly enrolled.
Pre-assignment Details If participants from previous SDP489 studies had a gap of more than 7 days before participation in this study, they were required to have baseline Attention-Deficit/Hyperactivity Disorder (ADHD) total score of at least 28, to be enrolled. Of 348 participants screened, 314 participants were enrolled and treated.
Arm/Group Title Lisdexamfetamine Dimesylate
Hide Arm/Group Description

Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 milligram (mg) capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.

At optimization period, participants started SPD489 30 mg and dose was titrated until acceptable response (30% reduction from baseline in ADHD Rating Scale-IV total score, clinical global impression-improvement [CGI-I]score of 1 or 2 with tolerable side effects) was achieved. Maximum dose was 70mg. Dose adjustments were done in dose maintenance period.

Period Title: Overall Study
Started 314
Completed 191
Not Completed 123
Reason Not Completed
Protocol Violation             4
Adverse Event             39
Lack of Efficacy             5
Withdrawal by Subject             41
Lost to Follow-up             5
Other             29
Arm/Group Title Lisdexamfetamine Dimesylate
Hide Arm/Group Description Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
Overall Number of Baseline Participants 314
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 314 participants
11.4  (2.88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 314 participants
Female
64
  20.4%
Male
250
  79.6%
Clinical Global Impressions – Severity of Illness (CGI-S) Rating   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 314 participants
Normal, not all ill 0
Borderline mentally ill 0
Mildly ill 1
Moderately ill 69
Markedly ill 152
Severely ill 81
Among the most extremely ill participants 11
[1]
Measure Description: The Clinical Global Impressions (CGI) Scale permits a global evaluation of the participant’s severity and improvement over time. This assessment will help guide the clinician on dosing adjustments. The CGI has been used extensively in clinical studies of ADHD. CGI-S was a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants), evaluated by the Investigator.
Body Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram(s)
Number Analyzed 314 participants
46.13  (16.434)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 314 participants
152.29  (16.633)
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilogram per square meter
Number Analyzed 314 participants
19.22  (3.389)
[1]
Measure Description: BMI was calculated as (weight [kilogram] per height [square meter]) at screening.
Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV): Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 314 participants
41.1  (7.03)
[1]
Measure Description: ADHD-RS-IV consisted of 18 items designed to reflect current symptomatology of ADHD based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition – Text Revision (DSM-IV-TR) criteria, completed by the Investigator. Each item was scored from a range of 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54. The 18 items were grouped into 2 sub-scales: hyperactivity/impulsivity (even number items 2-18 with score range of 0 to 27) and inattention (odd number items 1-17 with score range of 0 to 27). Higher scores depicted worse symptoms.
ADHD-RS-IV: Inattention Subscale Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 314 participants
22.1  (3.52)
[1]
Measure Description: ADHD-RS-IV consisted of 18 items designed to reflect current symptomatology of ADHD based on DSM-IV-TR criteria, completed by the Investigator. Each item was scored from a range of 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54. The 18 items were grouped into 2 sub-scales: hyperactivity/impulsivity and inattention. Inattention subscale score consisted of odd number items 1-17 with scores ranging from 0 to 27. Higher score indicated worse symptom.
ADHD-RS-IV: Hyperactivity/Impulsivity Subscore   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 314 participants
19  (5.86)
[1]
Measure Description: ADHD-RS-IV consisted of 18 items designed to reflect current symptomatology of ADHD based on DSM-IV-TR criteria, completed by the Investigator. Each item was scored from a range of 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54. The 18 items were grouped into 2 sub-scales: hyperactivity/impulsivity and inattention. Hyperactivity/impulsivity subscale score consisted of even number items 2-18 with scores ranging from 0 to 27. Higher score indicated worse symptom.
1.Primary Outcome
Title Number of Participants With All Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Hide Description An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. It included both serious and non-serious adverse event. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant’s first dose of investigational product in this study and the 3 days following cessation of treatment.
Time Frame Baseline up to 3 days after the last dose of study treatment (up to 2 years)
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Hide Analysis Population Description
Safety population included all participants who took at least 1 dose of Lisdexamfetamine dimesylate during this study.
Arm/Group Title Lisdexamfetamine Dimesylate
Hide Arm/Group Description:
Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
Overall Number of Participants Analyzed 314
Measure Type: Number
Unit of Measure: participants
Any TEAE 282
Serious TEAE 28
2.Primary Outcome
Title Change From Baseline in Pulse Rate at Last On-treatment Assessment (LOTA)
Hide Description [Not Specified]
Time Frame Baseline (Week 0), LOTA (Week 104)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population with participants evaluable for this outcome
Arm/Group Title Lisdexamfetamine Dimesylate
Hide Arm/Group Description:
Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
Overall Number of Participants Analyzed 313
Mean (Standard Deviation)
Unit of Measure: beats per minute
7  (11.6)
3.Primary Outcome
Title Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Last On-treatment Assessment (LOTA)
Hide Description [Not Specified]
Time Frame Baseline (Week 0), LOTA (Week 104)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population with participants evaluable for this outcome
Arm/Group Title Lisdexamfetamine Dimesylate
Hide Arm/Group Description:
Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
Overall Number of Participants Analyzed 313
Mean (Standard Deviation)
Unit of Measure: mmHg
3.2  (9.05)
4.Primary Outcome
Title Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Last On-treatment Assessment (LOTA)
Hide Description [Not Specified]
Time Frame Baseline (Week 0), LOTA (Week 104)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population with participants evaluable for this outcome
Arm/Group Title Lisdexamfetamine Dimesylate
Hide Arm/Group Description:
Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
Overall Number of Participants Analyzed 313
Mean (Standard Deviation)
Unit of Measure: mmHg
3.4  (10.33)
5.Primary Outcome
Title Change From Baseline in Body Weight at Last On-treatment Assessment (LOTA)
Hide Description [Not Specified]
Time Frame Baseline (Week 0), LOTA (Week 104)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population with participants evaluable for this outcome
Arm/Group Title Lisdexamfetamine Dimesylate
Hide Arm/Group Description:
Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
Overall Number of Participants Analyzed 313
Mean (Standard Deviation)
Unit of Measure: kilogram(s)
2.1  (5.83)
6.Primary Outcome
Title Change From Baseline in Height at Last On-treatment Assessment (LOTA)
Hide Description [Not Specified]
Time Frame Baseline (Week 0), LOTA (Week 104)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population with participants evaluable for this outcome
Arm/Group Title Lisdexamfetamine Dimesylate
Hide Arm/Group Description:
Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
Overall Number of Participants Analyzed 301
Mean (Standard Deviation)
Unit of Measure: centimeter(s)
6.1  (4.9)
7.Primary Outcome
Title Change From Baseline in Body Mass Index (BMI) at Last On-treatment Assessment (LOTA)
Hide Description BMI was calculated as (weight [kilogram] per height [square meter]).
Time Frame Baseline (Week 0), LOTA (Week 104)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population with participants evaluable for this outcome
Arm/Group Title Lisdexamfetamine Dimesylate
Hide Arm/Group Description:
Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
Overall Number of Participants Analyzed 313
Mean (Standard Deviation)
Unit of Measure: kilogram per square meter
-0.5  (1.72)
8.Primary Outcome
Title Change From Baseline in Heart Rate at Last On-treatment Assessment (LOTA)
Hide Description [Not Specified]
Time Frame Baseline (Week 0), LOTA (Week 104)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population with participants evaluable for this outcome
Arm/Group Title Lisdexamfetamine Dimesylate
Hide Arm/Group Description:
Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
Overall Number of Participants Analyzed 303
Mean (Standard Deviation)
Unit of Measure: beats per minute
7.1  (13.51)
9.Primary Outcome
Title Change From Baseline in QT Interval at Last On-treatment Assessment (LOTA)
Hide Description [Not Specified]
Time Frame Baseline (Week 0), LOTA (Week 104)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population with participants evaluable for this outcome
Arm/Group Title Lisdexamfetamine Dimesylate
Hide Arm/Group Description:
Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
Overall Number of Participants Analyzed 302
Mean (Standard Deviation)
Unit of Measure: milliseconds
-10.3  (23.53)
10.Primary Outcome
Title Change From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF) at Last On-treatment Assessment (LOTA)
Hide Description [Not Specified]
Time Frame Baseline (Week 0), LOTA (Week 104)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population with participants evaluable for this outcome
Arm/Group Title Lisdexamfetamine Dimesylate
Hide Arm/Group Description:
Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
Overall Number of Participants Analyzed 302
Mean (Standard Deviation)
Unit of Measure: milliseconds
-0.6  (15.24)
11.Primary Outcome
Title Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRSC) Total Scores at Last On-treatment Assessment (LOTA)
Hide Description The BPRS-C that was designed to provide a characterization of the child and adolescent psychopathology, was used to monitor participant's safety. The BPRS-C assessed 7 independent factors (3 items each), for a total of 21 items that represented behavioural disorders, depression, thinking disturbance, psychomotor excitation, withdrawal retardation, anxiety, and organicity. Each item was rated using a 7-point scale including 0 (not present), 1 (very mild), 2 (mild), 3 (moderate), 4 (moderately severe), 5 (severe), and 6 (extremely severe). Total score is the sum of each item score; range from 0 to 126. Higher score indicated worse psychology.
Time Frame Baseline (Week 0), LOTA (Week 104)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population with participants evaluable for this outcome
Arm/Group Title Lisdexamfetamine Dimesylate
Hide Arm/Group Description:
Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
Overall Number of Participants Analyzed 313
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-10.3  (9.64)
12.Secondary Outcome
Title Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Total Score at Last On-treatment Assessment (LOTA)
Hide Description ADHD-RS-IV consisted of 18 items designed to reflect current symptomatology of ADHD based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR) criteria, completed by the Investigator. Each item was scored from a range of 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54. The 18 items were grouped into 2 sub-scales: hyperactivity/impulsivity (even number items 2-18 with score range of 0 to 27) and inattention (odd number items 1-17 with score range of 0 to 27). Higher scores depicted worse symptoms.
Time Frame Baseline (Week 0), LOTA (Week 104)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) population included all participants who took at least 1 dose of SPD489 and had at least 1 on-treatment post baseline efficacy assessment.
Arm/Group Title Lisdexamfetamine Dimesylate
Hide Arm/Group Description:
Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
Overall Number of Participants Analyzed 299
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-25.8  (11.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lisdexamfetamine Dimesylate
Comments Change from baseline to LOTA value was assessed for differences from zero using a 2-sided, 1 sample t-test at a 0.05 significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
13.Secondary Outcome
Title Number of Participants With Clinical Global Impression-Global Improvement (CGI-I) at Last On-treatment Assessment (LOTA)
Hide Description The Clinical Global Impressions (CGI) Scale permits a global evaluation of the participants' severity and improvement over time. This assessment will help guide the clinician on dosing adjustments. The CGI has been used extensively in clinical studies of ADHD. CGI-I was a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), evaluated by the Investigator.
Time Frame LOTA (Week 104)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population
Arm/Group Title Lisdexamfetamine Dimesylate
Hide Arm/Group Description:
Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
Overall Number of Participants Analyzed 299
Measure Type: Number
Unit of Measure: participants
Very much improved 141
Much improved 92
Minimally improved 28
No change 20
Minimally worse 13
Much worse 5
Very much worse 0
14.Secondary Outcome
Title Number of Participants With Clinical Global Impression-Severity of Illness (CGI-S) at Last On-treatment Assessment (LOTA)
Hide Description The Clinical Global Impressions (CGI) Scale permits a global evaluation of the participants' severity and improvement over time. This assessment will help guide the clinician on dosing adjustments. The CGI has been used extensively in clinical studies of ADHD. CGI-S was a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants), evaluated by the Investigator.
Time Frame LOTA (Week 104)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population
Arm/Group Title Lisdexamfetamine Dimesylate
Hide Arm/Group Description:
Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
Overall Number of Participants Analyzed 299
Measure Type: Number
Unit of Measure: participants
Normal, not all ill 73
Borderline mentally ill 97
Mildly ill 67
Moderately ill 39
Markedly ill 17
Severely ill 4
Among the most extremely ill participants 2
Time Frame Baseline up to 3 days after the last dose of study treatment (up to 2 years)
Adverse Event Reporting Description AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant’s first dose of investigational product in this study and the 3 days following cessation of treatment.
 
Arm/Group Title Lisdexamfetamine Dimesylate
Hide Arm/Group Description Lisdexamfetamine dimesylate (Vyvanse, SPD489) 30 to 70 mg capsule once daily orally.
All-Cause Mortality
Lisdexamfetamine Dimesylate
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lisdexamfetamine Dimesylate
Affected / at Risk (%) # Events
Total   28/314 (8.92%)    
Blood and lymphatic system disorders   
Lymphadenitis * 1  1/314 (0.32%)  1
Cardiac disorders   
Arrhythmia * 1  1/314 (0.32%)  1
Gastrointestinal disorders   
Abdominal pain * 1  1/314 (0.32%)  1
Dental caries * 1  1/314 (0.32%)  1
Disbacteriosis * 1  1/314 (0.32%)  1
General disorders   
Condition aggravated * 1  1/314 (0.32%)  1
Pyrexia * 1  1/314 (0.32%)  1
Infections and infestations   
Appendicitis * 1  3/314 (0.96%)  3
Cellulitis * 1  1/314 (0.32%)  1
Infectious peritonitis * 1  1/314 (0.32%)  1
Lobar pneumonia * 1  1/314 (0.32%)  1
Mumps * 1  1/314 (0.32%)  1
Oral herpes * 1  1/314 (0.32%)  1
Pyelonephritis * 1  2/314 (0.64%)  2
Retroperitoneal abscess * 1  1/314 (0.32%)  1
Injury, poisoning and procedural complications   
Agitation postoperative * 1  1/314 (0.32%)  1
Humerus fracture * 1  1/314 (0.32%)  1
Post procedural haemorrhage * 1  1/314 (0.32%)  1
Subdural haematoma * 1  1/314 (0.32%)  1
Nervous system disorders   
Migraine * 1  1/314 (0.32%)  1
Syncope * 1  6/314 (1.91%)  7
Psychiatric disorders   
Oppositional defiant disorder * 1  1/314 (0.32%)  1
Panic attack * 1  1/314 (0.32%)  1
Suicidal ideation * 1  1/314 (0.32%)  1
Suicide attempt * 1  1/314 (0.32%)  1
Reproductive system and breast disorders   
Testicular torsion * 1  1/314 (0.32%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumothorax * 1  1/314 (0.32%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (14.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lisdexamfetamine Dimesylate
Affected / at Risk (%) # Events
Total   250/314 (79.62%)    
Gastrointestinal disorders   
Abdominal pain * 1  29/314 (9.24%)  37
Abdominal pain upper * 1  28/314 (8.92%)  34
Nausea * 1  31/314 (9.87%)  41
Vomiting * 1  27/314 (8.60%)  33
General disorders   
Irritability * 1  36/314 (11.46%)  39
Pyrexia * 1  31/314 (9.87%)  40
Infections and infestations   
Gastroenteritis * 1  18/314 (5.73%)  21
Nasopharyngitis * 1  73/314 (23.25%)  129
Pharyngitis * 1  16/314 (5.10%)  18
Investigations   
Weight decreased * 1  63/314 (20.06%)  68
Metabolism and nutrition disorders   
Decreased appetite * 1  170/314 (54.14%)  214
Nervous system disorders   
Headache * 1  68/314 (21.66%)  139
Psychiatric disorders   
Depressed mood * 1  19/314 (6.05%)  20
Initial insomnia * 1  38/314 (12.10%)  46
Insomnia * 1  60/314 (19.11%)  75
Tic * 1  18/314 (5.73%)  25
Respiratory, thoracic and mediastinal disorders   
Cough * 1  22/314 (7.01%)  25
Oropharyngeal pain * 1  18/314 (5.73%)  24
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (14.1)
Since this study is an open-label trial, results should be interpreted with caution.
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.
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Physician
Organization: Shire
Phone: 1 866-842-5335
Layout table for additonal information
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01328756     History of Changes
Obsolete Identifiers: NCT01413165
Other Study ID Numbers: SPD489-404
2010-020951-30 ( EudraCT Number )
First Submitted: March 29, 2011
First Posted: April 5, 2011
Results First Submitted: May 15, 2015
Results First Posted: August 6, 2015
Last Update Posted: August 6, 2015