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Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With Central Retinal Vein Occlusion (CRVO) (COMRADE-C)

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ClinicalTrials.gov Identifier: NCT01396083
Recruitment Status : Completed
First Posted : July 18, 2011
Results First Posted : February 18, 2015
Last Update Posted : September 27, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Visual Impairment
Macular Edema
Central Retinal Vein Occlusion
Interventions Drug: Ranibizumab
Drug: Dexamethasone implant and sham injections
Enrollment 243
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ranibizumab Dexamethasone
Hide Arm/Group Description Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
Period Title: Overall Study
Started 124 119
Completed 113 72
Not Completed 11 47
Reason Not Completed
Adverse Event             2             28
Unsatisfactory therapeutic effect             2             13
Consent withdrawn             4             5
Protocol deviation(s)             0             1
Abnormal laboratory value(s)             1             0
Administrative problems             1             0
Lost to Follow-up             1             0
Arm/Group Title Ranibizumab Dexamethasone Total
Hide Arm/Group Description Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months Total of all reporting groups
Overall Number of Baseline Participants 124 119 243
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 124 participants 119 participants 243 participants
65.3  (11.4) 66.9  (12.4) 66.1  (11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 124 participants 119 participants 243 participants
Female
52
  41.9%
46
  38.7%
98
  40.3%
Male
72
  58.1%
73
  61.3%
145
  59.7%
1.Primary Outcome
Title Mean Average BCVA Change From Month 1 Through Month 6 to Baseline
Hide Description the average of the changes in BCVA (letters) from baseline to any post-baseline visit, i.e. the mean of six differences to baseline for the six post-baseline visits at month 1 to 6. BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is pproximately 20/20. An increased score indicates improvement in acuity
Time Frame Baseline, month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned
Arm/Group Title Ranibizumab Dexamethasone
Hide Arm/Group Description:
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
Overall Number of Participants Analyzed 124 119
Mean (Standard Deviation)
Unit of Measure: Letters
14.6  (11.8) 4.8  (16.2)
2.Secondary Outcome
Title Mean BCVA Change at Month 6
Hide Description The analysis was performed by an analysis of covariance (ANCOVA) model with average change in BCVA (letters) from Visit 1 through Visit 6 as dependent variable, and with the factors center, treatment and covariate baseline BCVA as predictors
Time Frame Baseline, month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned
Arm/Group Title Ranibizumab Dexamethasone
Hide Arm/Group Description:
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
Overall Number of Participants Analyzed 124 119
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Letters
14.78
(11.24 to 18.32)
-3.17
(-6.80 to 0.46)
3.Secondary Outcome
Title Number of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters
Hide Description BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the number of participants who gained 15, 10 or 5 more letters of visual acuity at month 6 as compared with baseline
Time Frame Baseline, 6 month
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned
Arm/Group Title Ranibizumab Dexamethasone
Hide Arm/Group Description:
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
Overall Number of Participants Analyzed 124 119
Measure Type: Number
Unit of Measure: Participants
Gain≥15 letters 73 22
Loss of ≥15 letters 1 31
Gain ≥10 letters 89 38
Loss of ≥10 letters 4 35
Gain ≥5 letters 104 54
Loss of ≥5 letters 5 40
4.Secondary Outcome
Title Time to Achieve a Significant Improvement ≥ 15 Letters
Hide Description The time was analyzed by the Kaplan-Maier-Method, adjusting the calculation for dropouts
Time Frame Baseline, month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned
Arm/Group Title Ranibizumab Dexamethasone
Hide Arm/Group Description:
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
Overall Number of Participants Analyzed 124 119
Median (95% Confidence Interval)
Unit of Measure: Time to event (Days)
62
(56 to 91)
98 [1] 
(63 to NA)
[1]
NA - insufficient number of participants with events
5.Secondary Outcome
Title Change Over Time in BCVA
Hide Description The analysis was performed by an analysis of covariance (ANCOVA) model with average change in BCVA (letters) from Visit 1 through Visit 6 as dependent variable, and with the factors center, treatment and covariate baseline BCVA as predictors
Time Frame Baseline, month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned
Arm/Group Title Ranibizumab Dexamethasone
Hide Arm/Group Description:
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
Overall Number of Participants Analyzed 124 119
Least Squares Mean (95% Confidence Interval)
Unit of Measure: letters
Month 1
9.77
(7.27 to 12.27)
9.54
(6.98 to 12.10)
Month 2
12.25
(9.59 to 14.91)
11.04
(8.31 to 13.76)
Month 3
14.04
(10.92 to 17.16)
4.99
(1.79 to 8.18)
Month 4
12.76
(9.48 to 16.04)
-1.73
(-5.09 to 1.63)
Month 5
13.57
(10.25 to 16.89)
-2.92
(-6.33 to 0.48)
Month 6
14.78
(11.24 to 18.32)
-3.17
(-6.80 to 0.46)
6.Secondary Outcome
Title Change Over Time of the Central Retinal Thickness (CRT)
Hide Description Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation
Time Frame Baseline, month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned
Arm/Group Title Ranibizumab Dexamethasone
Hide Arm/Group Description:
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
Overall Number of Participants Analyzed 122 119
Mean (Standard Deviation)
Unit of Measure: µm
-376.7  (274.9) -168.7  (288.3)
7.Secondary Outcome
Title Changes in the Quality of Life According to the National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) Questionnaires
Hide Description The VFQ-25 composite and subscale scores range from 0 to 100, a higher score indicating better functioning. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated improvement in quality of life due to vision function
Time Frame Baseline, month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned
Arm/Group Title Ranibizumab Dexamethasone
Hide Arm/Group Description:
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
Overall Number of Participants Analyzed 121 118
Mean (Standard Deviation)
Unit of Measure: Score on a scale
6.0  (12.1) 2.0  (10.9)
8.Secondary Outcome
Title Changes in the Quality of Life According to the Short Form (36) Health Survey (SF-36)Questionnaires
Hide Description SF-36 summary measures are norm-based scores with mean = 50 and SD = 10. Higher scores indicate better health
Time Frame Baseline, month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. observed is only described in this analysis.
Arm/Group Title Ranibizumab Dexamethasone
Hide Arm/Group Description:
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
Overall Number of Participants Analyzed 116 113
Mean (Standard Deviation)
Unit of Measure: Units on a scale
SF-36 physical component (n=116,113) -0.7  (6.3) 0.4  (6.6)
SF-36 mental component (n=116,113) 2.4  (8.7) 0.4  (9.2)
9.Secondary Outcome
Title Changes in the Quality of Life According to Euro Quality of Life (EQ-5D) Questionnaires
Hide Description The EQ-5D visual analog scale ranges from 0 to 100, 0 representing the worst and 100 the best imaginable health state.
Time Frame Baseline, month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Observed participants are only described in this analysis
Arm/Group Title Ranibizumab Dexamethasone
Hide Arm/Group Description:
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
Overall Number of Participants Analyzed 116 113
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.1  (13.2) 2.0  (14.8)
10.Secondary Outcome
Title Increase Rate of the Internal Ocular Pressure (IOP ) : Patients With ≥10% Increase in IOP Compared to Baseline
Hide Description The proportion of patients with ≥ 10% increase in Internal Ocular Pressure (IOP) compared to baseline at any post-baseline visit.
Time Frame Baseline, month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set consisted of all patients from the RS who had received at least one application of study treatment and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received. The statement that a patient had no adverse events also constituted a safety assessment
Arm/Group Title Ranibizumab Dexamethasone
Hide Arm/Group Description:
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
Overall Number of Participants Analyzed 124 119
Measure Type: Number
Unit of Measure: Participants
94 105
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ranibizumab Dexamethasone
Hide Arm/Group Description Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
All-Cause Mortality
Ranibizumab Dexamethasone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ranibizumab Dexamethasone
Affected / at Risk (%) Affected / at Risk (%)
Total   10/124 (8.06%)   16/119 (13.45%) 
Cardiac disorders     
ANGINA PECTORIS  1  0/124 (0.00%)  1/119 (0.84%) 
ATRIAL FIBRILLATION  1  1/124 (0.81%)  1/119 (0.84%) 
CARDIAC FAILURE  1  0/124 (0.00%)  1/119 (0.84%) 
MITRAL VALVE INCOMPETENCE  1  0/124 (0.00%)  1/119 (0.84%) 
Congenital, familial and genetic disorders     
ADENOMATOUS POLYPOSIS COLI  1  1/124 (0.81%)  0/119 (0.00%) 
Ear and labyrinth disorders     
DEAFNESS  1  0/124 (0.00%)  1/119 (0.84%) 
Eye disorders     
CONJUNCTIVAL HYPERAEMIA (Study eye)  1  0/124 (0.00%)  1/119 (0.84%) 
CORNEAL OEDEMA (Study eye)  1  0/124 (0.00%)  1/119 (0.84%) 
EYE PAIN (Study eye)  1  0/124 (0.00%)  1/119 (0.84%) 
GLAUCOMA (Study eye)  1  0/124 (0.00%)  3/119 (2.52%) 
HYPHAEMA (Study eye)  1  0/124 (0.00%)  3/119 (2.52%) 
IRIS NEOVASCULARISATION (Study eye)  1  0/124 (0.00%)  4/119 (3.36%) 
MACULAR OEDEMA (Study eye)  1  1/124 (0.81%)  2/119 (1.68%) 
RETINAL ARTERY OCCLUSION (Study eye)  1  0/124 (0.00%)  1/119 (0.84%) 
RETINAL VEIN OCCLUSION (Study eye)  1  1/124 (0.81%)  1/119 (0.84%) 
VISUAL ACUITY REDUCED (Study eye)  1  0/124 (0.00%)  3/119 (2.52%) 
VITREOUS HAEMORRHAGE (Study eye)  1  0/124 (0.00%)  1/119 (0.84%) 
Gastrointestinal disorders     
ABDOMINAL HERNIA  1  0/124 (0.00%)  1/119 (0.84%) 
COLITIS  1  0/124 (0.00%)  1/119 (0.84%) 
GASTRODUODENAL ULCER  1  1/124 (0.81%)  0/119 (0.00%) 
OESOPHAGEAL RUPTURE  1  1/124 (0.81%)  0/119 (0.00%) 
UMBILICAL HERNIA  1  1/124 (0.81%)  0/119 (0.00%) 
General disorders     
ASTHENIA  1  1/124 (0.81%)  0/119 (0.00%) 
FATIGUE  1  1/124 (0.81%)  0/119 (0.00%) 
Infections and infestations     
CYSTITIS  1  1/124 (0.81%)  0/119 (0.00%) 
DIVERTICULITIS  1  0/124 (0.00%)  1/119 (0.84%) 
PNEUMONIA  1  1/124 (0.81%)  0/119 (0.00%) 
SOFT TISSUE INFECTION  1  0/124 (0.00%)  1/119 (0.84%) 
Injury, poisoning and procedural complications     
UPPER LIMB FRACTURE  1  1/124 (0.81%)  0/119 (0.00%) 
WRIST FRACTURE  1  1/124 (0.81%)  0/119 (0.00%) 
Investigations     
INTRAOCULAR PRESSURE DECREASED (Study eye)  1  0/124 (0.00%)  1/119 (0.84%) 
INTRAOCULAR PRESSURE INCREASED (Study eye)  1  0/124 (0.00%)  1/119 (0.84%) 
PROSTATIC SPECIFIC ANTIGEN INCREASED  1  1/124 (0.81%)  0/119 (0.00%) 
WEIGHT DECREASED  1  1/124 (0.81%)  0/119 (0.00%) 
Musculoskeletal and connective tissue disorders     
BACK PAIN  1  0/124 (0.00%)  1/119 (0.84%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
ADENOCARCINOMA OF COLON  1  0/124 (0.00%)  1/119 (0.84%) 
GASTROINTESTINAL CARCINOMA  1  0/124 (0.00%)  1/119 (0.84%) 
RENAL NEOPLASM  1  0/124 (0.00%)  1/119 (0.84%) 
Nervous system disorders     
HEADACHE  1  0/124 (0.00%)  1/119 (0.84%) 
RADIAL NERVE PALSY  1  0/124 (0.00%)  1/119 (0.84%) 
TRANSIENT ISCHAEMIC ATTACK  1  0/124 (0.00%)  2/119 (1.68%) 
Reproductive system and breast disorders     
PROSTATITIS  1  1/124 (0.81%)  0/119 (0.00%) 
Vascular disorders     
HYPERTENSION  1  0/124 (0.00%)  1/119 (0.84%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2.5%
Ranibizumab Dexamethasone
Affected / at Risk (%) Affected / at Risk (%)
Total   77/124 (62.10%)   99/119 (83.19%) 
Eye disorders     
ABNORMAL SENSATION IN EYE (Study eye)  1  6/124 (4.84%)  8/119 (6.72%) 
CONJUNCTIVAL HAEMORRHAGE (Study eye)  1  16/124 (12.90%)  13/119 (10.92%) 
DRY EYE (Fellow eye)  1  4/124 (3.23%)  1/119 (0.84%) 
DRY EYE (Study eye)  1  4/124 (3.23%)  4/119 (3.36%) 
EYE IRRITATION (Study eye)  1  4/124 (3.23%)  3/119 (2.52%) 
EYE PAIN (Study eye)  1  15/124 (12.10%)  14/119 (11.76%) 
FOREIGN BODY SENSATION IN EYES (Study eye)  1  6/124 (4.84%)  6/119 (5.04%) 
GLAUCOMA (Study eye)  1  0/124 (0.00%)  5/119 (4.20%) 
IRIS NEOVASCULARISATION (Study eye)  1  0/124 (0.00%)  5/119 (4.20%) 
LACRIMATION INCREASED (Study eye)  1  6/124 (4.84%)  8/119 (6.72%) 
MACULAR ISCHAEMIA (Study eye)  1  0/124 (0.00%)  3/119 (2.52%) 
MACULAR OEDEMA (Study eye)  1  13/124 (10.48%)  19/119 (15.97%) 
OCULAR HYPERAEMIA (Study eye)  1  14/124 (11.29%)  15/119 (12.61%) 
OCULAR HYPERTENSION (Study eye)  1  0/124 (0.00%)  6/119 (5.04%) 
OPTIC DISC VASCULAR DISORDER (Study eye)  1  5/124 (4.03%)  0/119 (0.00%) 
RETINAL EXUDATES (Study eye)  1  2/124 (1.61%)  4/119 (3.36%) 
RETINAL ISCHAEMIA (Study eye)  1  1/124 (0.81%)  6/119 (5.04%) 
RETINAL VASCULAR DISORDER (Study eye)  1  2/124 (1.61%)  5/119 (4.20%) 
VISUAL ACUITY REDUCED (Study eye)  1  8/124 (6.45%)  19/119 (15.97%) 
VISUAL IMPAIRMENT (Study eye)  1  2/124 (1.61%)  6/119 (5.04%) 
VITREOUS DETACHMENT (Study eye)  1  5/124 (4.03%)  3/119 (2.52%) 
VITREOUS FLOATERS (Study eye)  1  5/124 (4.03%)  11/119 (9.24%) 
Gastrointestinal disorders     
DIARRHOEA  1  6/124 (4.84%)  2/119 (1.68%) 
NAUSEA  1  4/124 (3.23%)  3/119 (2.52%) 
General disorders     
PYREXIA  1  0/124 (0.00%)  3/119 (2.52%) 
Infections and infestations     
BRONCHITIS  1  1/124 (0.81%)  3/119 (2.52%) 
NASOPHARYNGITIS  1  9/124 (7.26%)  12/119 (10.08%) 
URINARY TRACT INFECTION  1  1/124 (0.81%)  4/119 (3.36%) 
Investigations     
BLOOD GLUCOSE INCREASED  1  4/124 (3.23%)  2/119 (1.68%) 
INTRAOCULAR PRESSURE INCREASED (Fellow eye)  1  0/124 (0.00%)  3/119 (2.52%) 
INTRAOCULAR PRESSURE INCREASED (Study eye)  1  7/124 (5.65%)  38/119 (31.93%) 
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  2/124 (1.61%)  3/119 (2.52%) 
BACK PAIN  1  7/124 (5.65%)  4/119 (3.36%) 
Nervous system disorders     
HEADACHE  1  7/124 (5.65%)  10/119 (8.40%) 
Vascular disorders     
HYPERTENSION  1  5/124 (4.03%)  3/119 (2.52%) 
VASCULAR SHUNT (Study eye)  1  1/124 (0.81%)  3/119 (2.52%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
EMail: trialandresults.registries@novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01396083     History of Changes
Other Study ID Numbers: CRFB002EDE18
2011-001020-38 ( EudraCT Number )
First Submitted: July 14, 2011
First Posted: July 18, 2011
Results First Submitted: January 12, 2015
Results First Posted: February 18, 2015
Last Update Posted: September 27, 2016