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Safety and Efficacy of Levomilnacipran ER in Adolescent Participants With Major Depressive Disorder

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: NCT02431806
Recruitment Status : Completed
First Posted : May 1, 2015
Results First Posted : September 7, 2020
Last Update Posted : September 7, 2020
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: Placebo
Drug: Levomilnacipran
Drug: Fluoxetine
Enrollment 552
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Levomilnacipran 40 mg/Day Levomilnacipran 80 mg/Day Fluoxetine 20 mg/Day
Hide Arm/Group Description Participants received 2 dose matched over-encapsulated placebo capsules, once daily, orally during the Double-blind Treatment Period up to 8 weeks followed by a 1 week Taper-down Period if applicable as determined by the investigator. Participants received over-encapsulated levomilnacipran extended release (ER) 40 mg/day capsules orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Days 3-7 and 40 mg/day on Week 2 through Week 8 during the Double-Blind Treatment Period, followed by a 1-week Double-Blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind. Participants received over-encapsulated levomilnacipran ER two 40 mg/day capsules (80 mg/day) orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Day 3-4, 40 mg/day on Day 5-7 and 80 mg/day on Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule the first week and during the taper-down period to maintain the blind. Participants received over-encapsulated fluoxetine 20 mg/day tablets orally starting at a dose of 10 mg/day in Week 1 and 20 mg/day in Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.
Period Title: Double-blind Treatment Period
Started 142 136 139 135
Safety Population 141 134 138 134
Completed 117 115 107 109
Not Completed 25 21 32 26
Reason Not Completed
Did not Receive Treatment             1             2             1             1
Adverse Event             4             7             11             7
Lack of Efficacy             2             0             2             2
Withdrawal of Consent             10             7             5             5
Lost to Follow-up             7             4             5             8
Investigational Product Non-compliance             1             0             3             1
Reason Not Specified             0             1             5             2
Period Title: Double-blind Down-taper Period
Started 111 109 104 107
Completed 111 109 104 107
Not Completed 0 0 0 0
Arm/Group Title Placebo Levomilnacipran 40 mg/Day Levomilnacipran 80 mg/Day Fluoxetine 20 mg/Day Total
Hide Arm/Group Description Participants received 2 dose matched over-encapsulated placebo capsules, once daily, orally during the Double-blind Treatment Period up to 8 weeks followed by a 1 week Taper-down Period if applicable as determined by the investigator. Participants received over-encapsulated levomilnacipran extended release (ER) 40 mg/day capsules orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Days 3-7 and 40 mg/day on Week 2 through Week 8 during the Double-Blind Treatment Period, followed by a 1-week Double-Blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind. Participants received over-encapsulated levomilnacipran ER two 40 mg/day capsules (80 mg/day) orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Day 3-4, 40 mg/day on Day 5-7 and 80 mg/day on Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule the first week and during the taper-down period to maintain the blind. Participants received over-encapsulated fluoxetine 20 mg/day tablets orally starting at a dose of 10 mg/day in Week 1 and 20 mg/day in Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind. Total of all reporting groups
Overall Number of Baseline Participants 141 134 138 134 547
Hide Baseline Analysis Population Description
Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 141 participants 134 participants 138 participants 134 participants 547 participants
14.3  (1.59) 14.8  (1.62) 14.8  (1.75) 14.7  (1.67) 14.7  (1.67)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 141 participants 134 participants 138 participants 134 participants 547 participants
Female
98
  69.5%
94
  70.1%
87
  63.0%
84
  62.7%
363
  66.4%
Male
43
  30.5%
40
  29.9%
51
  37.0%
50
  37.3%
184
  33.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 141 participants 134 participants 138 participants 134 participants 547 participants
Hispanic or Latino
33
  23.4%
36
  26.9%
32
  23.2%
36
  26.9%
137
  25.0%
Not Hispanic or Latino
108
  76.6%
98
  73.1%
106
  76.8%
98
  73.1%
410
  75.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 141 participants 134 participants 138 participants 134 participants 547 participants
American Indian or Alaska Native
1
   0.7%
0
   0.0%
1
   0.7%
1
   0.7%
3
   0.5%
Asian
1
   0.7%
1
   0.7%
1
   0.7%
1
   0.7%
4
   0.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   0.7%
0
   0.0%
0
   0.0%
1
   0.2%
Black or African American
52
  36.9%
46
  34.3%
49
  35.5%
40
  29.9%
187
  34.2%
White
81
  57.4%
81
  60.4%
83
  60.1%
88
  65.7%
333
  60.9%
More than one race
6
   4.3%
4
   3.0%
3
   2.2%
4
   3.0%
17
   3.1%
Unknown or Not Reported
0
   0.0%
1
   0.7%
1
   0.7%
0
   0.0%
2
   0.4%
Children's Depression Rating Scale-Revised (CDRS-R) Total Score   [1] [2] 
Mean (Full Range)
Unit of measure:  Score on a scale
Number Analyzed 140 participants 134 participants 138 participants 134 participants 546 participants
61.1
(40 to 83)
61.8
(32 to 88)
59.4
(41 to 81)
61.5
(40 to 92)
60.95
(32 to 92)
[1]
Measure Description: CDRS-R is a 17-item scale measuring presence and severity of symptoms commonly associated with childhood depression and is scored on a 1-to-5- or 1-to-7-point scale. Rating of 1 indicates normal function. The CDRS-R total score ranges from 17 to 113; higher score indicates more severe depression.
[2]
Measure Analysis Population Description: Intent to Treat (ITT) Population included all participants in the Safety Population who had the baseline and at least 1 postbaseline assessment of the CDRS-R total score.
Clinical Global Impression-Severity (CGI-S) Scale   [1] [2] 
Mean (Full Range)
Unit of measure:  Score on a scale
Number Analyzed 140 participants 134 participants 138 participants 134 participants 546 participants
4.7
(4 to 6)
4.8
(3 to 6)
4.7
(4 to 6)
4.7
(4 to 6)
4.7
(3 to 6)
[1]
Measure Description: The CGI-S is a clinician-rated scale used to rate the severity of the participant's current state of mental illness compared with major depressive disorder (MDD) population. The participant was rated on a scale from 1 to 7, where 1= Very much improved; 2= Much improved; 3= Minimally improved; 4= No change; 5= Minimally worse; 6= Much worse; 7= Very much worse. Higher score indicates worsening of mental illness.
[2]
Measure Analysis Population Description: ITT Population included all participants in the Safety Population who had the baseline and at least 1 postbaseline assessment of the CDRS-R total score. Overall number of participants analyzed is the number of participants with data available for analyses.
1.Primary Outcome
Title Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score
Hide Description CDRS-R is a 17-item scale measuring presence and severity of symptoms commonly associated with childhood depression and is scored on a 1-to-5- or 1-to-7-point scale. Rating of 1 indicates normal function. The CDRS-R total score ranges from 17 to 113; higher score indicates more severe depression. A negative change from Baseline indicates improvement. Mixed Model for Repeated Measures (MMRM) was used for analysis.
Time Frame Baseline (Week 0) to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all participants in the Safety Population who had the baseline and at least 1 postbaseline assessment of the CDRS-R total score. Overall number of participants analyzed is the number of participants with data available for analyses.
Arm/Group Title Placebo Levomilnacipran 40 mg/Day Levomilnacipran 80 mg/Day Fluoxetine 20 mg/Day
Hide Arm/Group Description:
Participants received 2 dose matched over-encapsulated placebo capsules, once daily, orally during the Double-blind Treatment Period up to 8 weeks followed by a 1 week Taper-down Period if applicable as determined by the investigator.
Participants received over-encapsulated levomilnacipran extended release (ER) 40 mg/day capsules orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Days 3-7 and 40 mg/day on Week 2 through Week 8 during the Double-Blind Treatment Period, followed by a 1-week Double-Blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.
Participants received over-encapsulated levomilnacipran ER two 40 mg/day capsules (80 mg/day) orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Day 3-4, 40 mg/day on Day 5-7 and 80 mg/day on Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule the first week and during the taper-down period to maintain the blind.
Participants received over-encapsulated fluoxetine 20 mg/day tablets orally starting at a dose of 10 mg/day in Week 1 and 20 mg/day in Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.
Overall Number of Participants Analyzed 118 115 110 112
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-22.90  (1.09) -23.28  (1.11) -22.64  (1.12) -24.37  (1.12)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levomilnacipran 40 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8035
Comments [Not Specified]
Method Mixed Model Repeated Measures (MMRM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares (LS) Mean Difference
Estimated Value -0.38
Confidence Interval (2-Sided) 95%
-3.41 to 2.64
Estimation Comments Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Levomilnacipran 80 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8681
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.26
Confidence Interval (2-Sided) 95%
-2.80 to 3.31
Estimation Comments Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Fluoxetine 20 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3439
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean
Estimated Value -1.47
Confidence Interval (2-Sided) 95%
-4.52 to 1.58
Estimation Comments Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.
2.Secondary Outcome
Title Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale
Hide Description The CGI-S is a clinician-rated scale used to rate the severity of the participants current state of mental illness compared with MDD population. The participant was rated on a scale from 1 to 7, where 1= Very much improved; 2= Much improved; 3= Minimally improved; 4= No change; 5= Minimally worse; 6= Much worse; 7= Very much worse. Higher score indicates worsening of mental illness. A negative change from Baseline indicates improvement. MMRM was used for analysis.
Time Frame Baseline (Week 0) to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all participants in the Safety Population who had the baseline and at least 1 postbaseline assessment of the Children's Depression Rating Scale-Revised (CDRS-R) total score. Overall number of participants analyzed is the number of participants with data available for analyses.
Arm/Group Title Placebo Levomilnacipran 40 mg/Day Levomilnacipran 80 mg/Day Fluoxetine 20 mg/Day
Hide Arm/Group Description:
Participants received 2 dose matched over-encapsulated placebo capsules, once daily, orally during the Double-blind Treatment Period up to 8 weeks followed by a 1 week Taper-down Period if applicable as determined by the investigator.
Participants received over-encapsulated levomilnacipran extended release (ER) 40 mg/day capsules orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Days 3-7 and 40 mg/day on Week 2 through Week 8 during the Double-Blind Treatment Period, followed by a 1-week Double-Blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.
Participants received over-encapsulated levomilnacipran ER two 40 mg/day capsules (80 mg/day) orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Day 3-4, 40 mg/day on Day 5-7 and 80 mg/day on Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule the first week and during the taper-down period to maintain the blind.
Participants received over-encapsulated fluoxetine 20 mg/day tablets orally starting at a dose of 10 mg/day in Week 1 and 20 mg/day in Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.
Overall Number of Participants Analyzed 118 115 110 112
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-1.54  (0.10) -1.52  (0.10) -1.52  (0.10) -1.68  (0.10)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Levomilnacipran 40 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8788
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.25 to 0.29
Estimation Comments Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Levomilnacipran 80 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9230
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.01
Confidence Interval (2-Sided) 95%
-0.26 to 0.29
Estimation Comments Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Fluoxetine 20 mg/Day
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2895
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.15
Confidence Interval (2-Sided) 95%
-0.42 to 0.13
Estimation Comments Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.
Time Frame First dose of study treatment to end of study follow-up (Up to 10 Weeks)
Adverse Event Reporting Description Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.
 
Arm/Group Title Placebo Levomilnacipran 40 mg/Day Levomilnacipran 80 mg/Day Fluoxetine 20 mg/Day
Hide Arm/Group Description Participants received 2 dose matched over-encapsulated placebo capsules, once daily, orally during the Double-blind Treatment Period up to 8 weeks followed by a 1 week Taper-down Period if applicable as determined by the investigator. Participants received over-encapsulated levomilnacipran extended release (ER) 40 mg/day capsules orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Days 3-7 and 40 mg/day on Week 2 through Week 8 during the Double-Blind Treatment Period, followed by a 1-week Double-Blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind. Participants received over-encapsulated levomilnacipran ER two 40 mg/day capsules (80 mg/day) orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Day 3-4, 40 mg/day on Day 5-7 and 80 mg/day on Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule the first week and during the taper-down period to maintain the blind. Participants received over-encapsulated fluoxetine 20 mg/day tablets orally starting at a dose of 10 mg/day in Week 1 and 20 mg/day in Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.
All-Cause Mortality
Placebo Levomilnacipran 40 mg/Day Levomilnacipran 80 mg/Day Fluoxetine 20 mg/Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/141 (0.00%)   0/134 (0.00%)   0/138 (0.00%)   0/134 (0.00%) 
Hide Serious Adverse Events
Placebo Levomilnacipran 40 mg/Day Levomilnacipran 80 mg/Day Fluoxetine 20 mg/Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/141 (0.00%)   2/134 (1.49%)   0/138 (0.00%)   4/134 (2.99%) 
Gastrointestinal disorders         
Faecaloma  1  0/141 (0.00%)  0/134 (0.00%)  0/138 (0.00%)  1/134 (0.75%) 
Injury, poisoning and procedural complications         
Overdose  1  0/141 (0.00%)  1/134 (0.75%)  0/138 (0.00%)  0/134 (0.00%) 
Intentional overdose  1  0/141 (0.00%)  0/134 (0.00%)  0/138 (0.00%)  1/134 (0.75%) 
Psychiatric disorders         
Suicide attempt  1  0/141 (0.00%)  1/134 (0.75%)  0/138 (0.00%)  1/134 (0.75%) 
Suicidal ideation  1  0/141 (0.00%)  0/134 (0.00%)  0/138 (0.00%)  1/134 (0.75%) 
1
Term from vocabulary, MedDRA : 22.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Levomilnacipran 40 mg/Day Levomilnacipran 80 mg/Day Fluoxetine 20 mg/Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   33/141 (23.40%)   54/134 (40.30%)   63/138 (45.65%)   41/134 (30.60%) 
Cardiac disorders         
Tachycardia  1  1/141 (0.71%)  13/134 (9.70%)  12/138 (8.70%)  5/134 (3.73%) 
Gastrointestinal disorders         
Nausea  1  8/141 (5.67%)  19/134 (14.18%)  22/138 (15.94%)  5/134 (3.73%) 
Abdominal pain upper  1  4/141 (2.84%)  6/134 (4.48%)  7/138 (5.07%)  4/134 (2.99%) 
Vomiting  1  3/141 (2.13%)  11/134 (8.21%)  11/138 (7.97%)  4/134 (2.99%) 
Infections and infestations         
Nasopharyngitis  1  3/141 (2.13%)  4/134 (2.99%)  7/138 (5.07%)  7/134 (5.22%) 
Metabolism and nutrition disorders         
Decreased appetite  1  2/141 (1.42%)  7/134 (5.22%)  9/138 (6.52%)  10/134 (7.46%) 
Nervous system disorders         
Headache  1  15/141 (10.64%)  20/134 (14.93%)  19/138 (13.77%)  13/134 (9.70%) 
Dizziness  1  5/141 (3.55%)  5/134 (3.73%)  9/138 (6.52%)  3/134 (2.24%) 
Somnolence  1  3/141 (2.13%)  6/134 (4.48%)  8/138 (5.80%)  2/134 (1.49%) 
1
Term from vocabulary, MedDRA : 22.0
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.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area Head
Organization: Allergan
Phone: 714-246-4500
EMail: clinicaltrials@allergan.com
Layout table for additonal information
Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT02431806    
Obsolete Identifiers: NCT03087916
Other Study ID Numbers: LVM-MD-11
First Submitted: April 28, 2015
First Posted: May 1, 2015
Results First Submitted: August 19, 2020
Results First Posted: September 7, 2020
Last Update Posted: September 7, 2020