Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

P3 Study Brodalumab in Treatment of Moderate to Severe Plaque Psoriasis (AMAGINE-2)

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: NCT01708603
Recruitment Status : Terminated (Sponsor decision)
First Posted : October 17, 2012
Results First Posted : January 6, 2020
Last Update Posted : January 6, 2020
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Moderate to Severe Plaque Psoriasis
Interventions Drug: 210 mg brodalumab
Drug: 140 mg brodalumab
Drug: ustekinumab
Drug: placebo
Enrollment 1831
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 210 mg Brodalumab 140 mg Brodalumab Ustekinumab Placebo
Hide Arm/Group Description

Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.

210 mg brodalumab: 210 mg brodalumab administered SC

Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.

140 mg brodalumab: 140 mg brodalumab administered SC

Administered by subcutaneous (SC) injection per the labeled dosing regimen.

ustekinumab: 45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.

Administered by subcutaneous (SC) injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.

210 mg brodalumab: 210 mg brodalumab administered SC

placebo: Placebo administered SC

Period Title: Overall Study
Started 612 610 300 309
Completed 597 588 291 300
Not Completed 15 22 9 9
Arm/Group Title 210 mg Brodalumab 140 mg Brodalumab Ustekinumab Placebo Total
Hide Arm/Group Description

Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.

210 mg brodalumab: 210 mg brodalumab administered SC

Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.

140 mg brodalumab: 140 mg brodalumab administered SC

Administered by subcutaneous (SC) injection per the labeled dosing regimen.

ustekinumab: 45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.

Administered by subcutaneous (SC) injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.

210 mg brodalumab: 210 mg brodalumab administered SC

placebo: Placebo administered SC

Total of all reporting groups
Overall Number of Baseline Participants 612 610 300 309 1831
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 612 participants 610 participants 300 participants 309 participants 1831 participants
44.5  (12.7) 44.8  (12.8) 45.4  (13.0) 43.7  (12.9) 44.6  (12.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 612 participants 610 participants 300 participants 309 participants 1831 participants
Female
191
  31.2%
197
  32.3%
95
  31.7%
90
  29.1%
573
  31.3%
Male
421
  68.8%
413
  67.7%
205
  68.3%
219
  70.9%
1258
  68.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 612 participants 610 participants 300 participants 309 participants 1831 participants
American Indian or Alaska Native
3
   0.5%
2
   0.3%
1
   0.3%
2
   0.6%
8
   0.4%
Asian
19
   3.1%
25
   4.1%
12
   4.0%
12
   3.9%
68
   3.7%
Native Hawaiian or Other Pacific Islander
5
   0.8%
4
   0.7%
0
   0.0%
0
   0.0%
9
   0.5%
Black or African American
19
   3.1%
13
   2.1%
7
   2.3%
14
   4.5%
53
   2.9%
White
551
  90.0%
557
  91.3%
271
  90.3%
273
  88.3%
1652
  90.2%
More than one race
5
   0.8%
1
   0.2%
3
   1.0%
1
   0.3%
10
   0.5%
Unknown or Not Reported
10
   1.6%
8
   1.3%
6
   2.0%
7
   2.3%
31
   1.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 612 participants 610 participants 300 participants 309 participants 1831 participants
Canada 64 66 32 33 195
Czechia 18 20 7 8 53
Netherlands 5 6 3 3 17
Austria 6 8 2 4 20
Hungary 18 15 8 10 50
United States 286 281 140 144 851
Poland 130 132 65 64 391
Australia 40 39 20 19 118
France 14 13 9 8 44
Portugal 12 10 4 6 32
Spain 19 20 10 10 59
1.Primary Outcome
Title Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12
Hide Description Measures the physician's impression of the disease at a single point, and a dynamic form in which the physician assesses the global improvement from baseline. Success is defined by a score of 0 or 1 (clear to almost clear).
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 210 mg Brodalumab 140 mg Brodalumab Placebo Ustekinumab
Hide Arm/Group Description:

Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.

210 mg brodalumab: 210 mg brodalumab administered SC

Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.

140 mg brodalumab: 140 mg brodalumab administered SC

Administered by subcutaneous (SC) injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.

210 mg brodalumab: 210 mg brodalumab administered SC

placebo: Placebo administered SC

Administered by subcutaneous (SC) injection until week 12. Participants using Ustekinumab were not rerandomized at week 12, and continued to receive ustekinumab.
Overall Number of Participants Analyzed 612 610 309 300
Measure Type: Count of Participants
Unit of Measure: Participants
481
  78.6%
354
  58.0%
12
   3.9%
183
  61.0%
2.Primary Outcome
Title Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12
Hide Description to evaluate the efficacy of Brodalumab (210mg every 2 weeks, and 140mg every 2 weeks) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index, PASI75 at week 12.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 210 mg Brodalumab 140 mg Brodalumab Placebo Ustekinumab
Hide Arm/Group Description:

Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.

210 mg brodalumab: 210 mg brodalumab administered SC

Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.

140 mg brodalumab: 140 mg brodalumab administered SC

Brodalumab Placebo
Administered by subcutaneous (SC) injection until week 12. Participants using Ustekinumab were not rerandomized at week 12, and continued to receive ustekinumab.
Overall Number of Participants Analyzed 612 610 309 300
Measure Type: Count of Participants
Unit of Measure: Participants
528
  86.3%
406
  66.6%
25
   8.1%
210
  70.0%
3.Primary Outcome
Title Percentage of Participants With Psoriasis Area Severity Index (PASI) 100 at Week 12
Hide Description to evaluate the efficacy of Brodalumab (210mg Q2W) in clearing psoriasis as measured by the proportion of subjects achieving PASI 100 at week 12.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Brodalumab 210mg Brodalumab 140mg Placebo Ustekinumab
Hide Arm/Group Description:
Brodalumab 210mg Q2W
Brodalumab 140mg Q2W
Brodalumab placebo
Ustekinumab administered in a dose of 45mg in a prefilled syringe of 0.5mL
Overall Number of Participants Analyzed 612 610 309 300
Measure Type: Count of Participants
Unit of Measure: Participants
272
  44.4%
157
  25.7%
2
   0.6%
65
  21.7%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 210 mg Brodalumab 140 mg Brodalumab Ustekinumab Placebo
Hide Arm/Group Description

Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.

210 mg brodalumab: 210 mg brodalumab administered SC

Administered by subcutaneous (SC) injection until week 12. At week 12, participants are rerandomized to schedule 1, 2, 3, or 4.

140 mg brodalumab: 140 mg brodalumab administered SC

Administered by subcutaneous (SC) injection per the labeled dosing regimen.

ustekinumab: 45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.

Administered by subcutaneous (SC) injection until week 12. At week 12 participants are assigned to 210 mg brodalumab.

210 mg brodalumab: 210 mg brodalumab administered SC

placebo: Placebo administered SC

All-Cause Mortality
210 mg Brodalumab 140 mg Brodalumab Ustekinumab Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
210 mg Brodalumab 140 mg Brodalumab Ustekinumab Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/612 (0.98%)   13/610 (2.13%)   4/300 (1.33%)   8/309 (2.59%) 
Blood and lymphatic system disorders         
Blood Glucose Increased *  0/612 (0.00%)  0/610 (0.00%)  0/300 (0.00%)  1/309 (0.32%) 
Cardiac disorders         
Angina Pectoris *  0/612 (0.00%)  1/610 (0.16%)  0/300 (0.00%)  0/309 (0.00%) 
Angina Unstable *  0/612 (0.00%)  1/610 (0.16%)  0/300 (0.00%)  0/309 (0.00%) 
Anteriosclerosis *  0/612 (0.00%)  1/610 (0.16%)  0/300 (0.00%)  0/309 (0.00%) 
General disorders         
Diabetes Mellitus Inadequate Control *  0/612 (0.00%)  0/610 (0.00%)  0/300 (0.00%)  1/309 (0.32%) 
Dysponea *  0/612 (0.00%)  0/610 (0.00%)  0/300 (0.00%)  1/309 (0.32%) 
Noncardiac Chest Pain *  0/612 (0.00%)  0/610 (0.00%)  0/300 (0.00%)  1/309 (0.32%) 
Syncope *  0/612 (0.00%)  0/610 (0.00%)  0/300 (0.00%)  1/309 (0.32%) 
Alcohol Abuse *  1/612 (0.16%)  0/610 (0.00%)  0/300 (0.00%)  0/309 (0.00%) 
Chondromalacia *  0/612 (0.00%)  1/610 (0.16%)  0/300 (0.00%)  0/309 (0.00%) 
Chondropathy *  0/612 (0.00%)  1/610 (0.16%)  0/300 (0.00%)  0/309 (0.00%) 
Drug Detoxification *  0/612 (0.00%)  1/610 (0.16%)  0/300 (0.00%)  0/309 (0.00%) 
Fibromyalgia *  0/612 (0.00%)  1/610 (0.16%)  0/300 (0.00%)  0/309 (0.00%) 
Vertigo *  0/612 (0.00%)  0/610 (0.00%)  1/300 (0.33%)  0/309 (0.00%) 
Infections and infestations         
Pancreatitis Acute *  0/612 (0.00%)  1/610 (0.16%)  0/300 (0.00%)  1/309 (0.32%) 
Appendicitis *  1/612 (0.16%)  1/610 (0.16%)  0/300 (0.00%)  0/309 (0.00%) 
Cellulitis *  1/612 (0.16%)  1/610 (0.16%)  0/300 (0.00%)  0/309 (0.00%) 
Escherichia Urinary tract Infection *  0/612 (0.00%)  0/610 (0.00%)  0/300 (0.00%)  1/309 (0.32%) 
Injury, poisoning and procedural complications         
Hip Fracture *  0/612 (0.00%)  0/610 (0.00%)  0/300 (0.00%)  1/309 (0.32%) 
Ligament Rupture *  0/612 (0.00%)  0/610 (0.00%)  0/300 (0.00%)  1/309 (0.32%) 
Carbon Monoxide Poisining *  1/612 (0.16%)  0/610 (0.00%)  0/300 (0.00%)  0/309 (0.00%) 
Cerbebral Infarction *  1/612 (0.16%)  0/610 (0.00%)  0/300 (0.00%)  0/309 (0.00%) 
Joint Capsule Rupture *  0/612 (0.00%)  1/610 (0.16%)  0/300 (0.00%)  0/309 (0.00%) 
Ligament Injury *  0/612 (0.00%)  1/610 (0.16%)  0/300 (0.00%)  0/309 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Prostate Cancer *  0/612 (0.00%)  0/610 (0.00%)  1/300 (0.33%)  0/309 (0.00%) 
Psychiatric disorders         
Suicide attempt *  1/612 (0.16%)  0/610 (0.00%)  0/300 (0.00%)  0/309 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Pneumothorax *  0/612 (0.00%)  0/610 (0.00%)  1/300 (0.33%)  0/309 (0.00%) 
Vascular disorders         
Hypertension *  0/612 (0.00%)  1/610 (0.16%)  0/300 (0.00%)  0/309 (0.00%) 
Acute Coronary Syndrome *  0/612 (0.00%)  0/610 (0.00%)  1/300 (0.33%)  0/309 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
210 mg Brodalumab 140 mg Brodalumab Ustekinumab Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   354/612 (57.84%)   365/610 (59.84%)   177/300 (59.00%)   165/309 (53.40%) 
Gastrointestinal disorders         
Diarrhoea *  12/612 (1.96%)  13/610 (2.13%)  2/300 (0.67%)  4/309 (1.29%) 
Nausea *  11/612 (1.80%)  9/610 (1.48%)  5/300 (1.67%)  5/309 (1.62%) 
Toothache *  7/612 (1.14%)  6/610 (0.98%)  6/300 (2.00%)  4/309 (1.29%) 
Abdominal Pain *  4/612 (0.65%)  8/610 (1.31%)  1/300 (0.33%)  4/309 (1.29%) 
Abdominal Pain Upper *  2/612 (0.33%)  10/610 (1.64%)  2/300 (0.67%)  1/309 (0.32%) 
Dyspepsia *  4/612 (0.65%)  5/610 (0.82%)  3/300 (1.00%)  1/309 (0.32%) 
Vomiting *  4/612 (0.65%)  4/610 (0.66%)  3/300 (1.00%)  1/309 (0.32%) 
Dry Mouth *  2/612 (0.33%)  5/610 (0.82%)  0/300 (0.00%)  1/309 (0.32%) 
Constipation *  1/612 (0.16%)  3/610 (0.49%)  2/300 (0.67%)  1/309 (0.32%) 
General disorders         
Fatigue *  16/612 (2.61%)  11/610 (1.80%)  12/300 (4.00%)  2/309 (0.65%) 
Pyrexia *  8/612 (1.31%)  6/610 (0.98%)  2/300 (0.67%)  0/309 (0.00%) 
Peripheral Swelling *  4/612 (0.65%)  4/610 (0.66%)  0/300 (0.00%)  3/309 (0.97%) 
Asthenia *  5/612 (0.82%)  6/610 (0.98%)  4/300 (1.33%)  1/309 (0.32%) 
Odema Peripheral *  2/612 (0.33%)  2/610 (0.33%)  1/300 (0.33%)  4/309 (1.29%) 
Injection Site Pain *  3/612 (0.49%)  5/610 (0.82%)  0/300 (0.00%)  1/309 (0.32%) 
Non-cardiac Chest Pain *  0/612 (0.00%)  0/610 (0.00%)  1/300 (0.33%)  2/309 (0.65%) 
Infections and infestations         
Nasopharyngitis *  45/612 (7.35%)  45/610 (7.38%)  18/300 (6.00%)  14/309 (4.53%) 
Upper respiratory Tract infection *  33/612 (5.39%)  30/610 (4.92%)  20/300 (6.67%)  23/309 (7.44%) 
Bronchitis *  12/612 (1.96%)  3/610 (0.49%)  4/300 (1.33%)  3/309 (0.97%) 
Sinusitis *  7/612 (1.14%)  3/610 (0.49%)  7/300 (2.33%)  3/309 (0.97%) 
Urinary tract Infection *  3/612 (0.49%)  8/610 (1.31%)  2/300 (0.67%)  4/309 (1.29%) 
Influenza *  7/612 (1.14%)  7/610 (1.15%)  1/300 (0.33%)  1/309 (0.32%) 
Viral Upper respiratory Tract Infection *  6/612 (0.98%)  5/610 (0.82%)  3/300 (1.00%)  0/309 (0.00%) 
Gastroenteritis *  3/612 (0.49%)  3/610 (0.49%)  2/300 (0.67%)  4/309 (1.29%) 
Rhinitis *  2/612 (0.33%)  3/610 (0.49%)  4/300 (1.33%)  2/309 (0.65%) 
Pharyngitis *  7/612 (1.14%)  3/610 (0.49%)  1/300 (0.33%)  0/309 (0.00%) 
Folliculitis *  7/612 (1.14%)  3/610 (0.49%)  1/300 (0.33%)  0/309 (0.00%) 
Oral Herpes *  2/612 (0.33%)  2/610 (0.33%)  4/300 (1.33%)  0/309 (0.00%) 
Conjuncitvitus *  2/612 (0.33%)  3/610 (0.49%)  1/300 (0.33%)  1/309 (0.32%) 
Gastroenteritis Viral *  1/612 (0.16%)  5/610 (0.82%)  0/300 (0.00%)  1/309 (0.32%) 
Laryngitis *  3/612 (0.49%)  2/610 (0.33%)  0/300 (0.00%)  1/309 (0.32%) 
Tooth Infection *  2/612 (0.33%)  1/610 (0.16%)  2/300 (0.67%)  1/309 (0.32%) 
Otitis Media *  4/612 (0.65%)  1/610 (0.16%)  1/300 (0.33%)  0/309 (0.00%) 
Skin Infection *  2/612 (0.33%)  3/610 (0.49%)  1/300 (0.33%)  0/309 (0.00%) 
Injury, poisoning and procedural complications         
Muscle Strain *  13/612 (2.12%)  9/610 (1.48%)  3/300 (1.00%)  5/309 (1.62%) 
Laceration *  1/612 (0.16%)  4/610 (0.66%)  3/300 (1.00%)  3/309 (0.97%) 
Joint Injury *  1/612 (0.16%)  1/610 (0.16%)  0/300 (0.00%)  2/309 (0.65%) 
Metabolism and nutrition disorders         
Gout *  3/612 (0.49%)  3/610 (0.49%)  1/300 (0.33%)  3/309 (0.97%) 
Musculoskeletal and connective tissue disorders         
Arthralgia *  28/612 (4.58%)  33/610 (5.41%)  9/300 (3.00%)  12/309 (3.88%) 
Back Pain *  9/612 (1.47%)  17/610 (2.79%)  4/300 (1.33%)  3/309 (0.97%) 
Pain in Extremity *  10/612 (1.63%)  9/610 (1.48%)  2/300 (0.67%)  6/309 (1.94%) 
Myalgia *  2/612 (0.33%)  2/610 (0.33%)  2/300 (0.67%)  0/309 (0.00%) 
Psoriatic Arthropathy *  4/612 (0.65%)  11/610 (1.80%)  0/300 (0.00%)  1/309 (0.32%) 
Muskuloskelital Pain *  5/612 (0.82%)  7/610 (1.15%)  1/300 (0.33%)  2/309 (0.65%) 
Arthritis *  4/612 (0.65%)  2/610 (0.33%)  1/300 (0.33%)  0/309 (0.00%) 
Osteoarthritis *  3/612 (0.49%)  3/610 (0.49%)  1/300 (0.33%)  0/309 (0.00%) 
Neck Pain *  5/612 (0.82%)  1/610 (0.16%)  0/300 (0.00%)  0/309 (0.00%) 
Tendonitis *  1/612 (0.16%)  2/610 (0.33%)  3/300 (1.00%)  0/309 (0.00%) 
Muscle Spasms *  2/612 (0.33%)  1/610 (0.16%)  2/300 (0.67%)  0/309 (0.00%) 
Joint Swelling *  1/612 (0.16%)  2/610 (0.33%)  0/300 (0.00%)  1/309 (0.32%) 
Groin Pain *  3/612 (0.49%)  0/610 (0.00%)  1/300 (0.33%)  0/309 (0.00%) 
Nervous system disorders         
headache *  31/612 (5.07%)  35/610 (5.74%)  12/300 (4.00%)  9/309 (2.91%) 
Paraesthesia *  3/612 (0.49%)  4/610 (0.66%)  2/300 (0.67%)  1/309 (0.32%) 
Sciatica *  3/612 (0.49%)  5/610 (0.82%)  1/300 (0.33%)  1/309 (0.32%) 
Dizziness *  3/612 (0.49%)  1/610 (0.16%)  1/300 (0.33%)  2/309 (0.65%) 
Migrane *  2/612 (0.33%)  1/610 (0.16%)  2/300 (0.67%)  0/309 (0.00%) 
Sinus headache *  2/612 (0.33%)  0/610 (0.00%)  0/300 (0.00%)  0/309 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Oropharyngeal Pain *  10/612 (1.63%)  12/610 (1.97%)  1/300 (0.33%)  5/309 (1.62%) 
Cough *  7/612 (1.14%)  5/610 (0.82%)  1/300 (0.33%)  6/309 (1.94%) 
Hyperuricaemia *  2/612 (0.33%)  3/610 (0.49%)  2/300 (0.67%)  4/309 (1.29%) 
Skin and subcutaneous tissue disorders         
Pruritus *  14/612 (2.29%)  19/610 (3.11%)  6/300 (2.00%)  7/309 (2.27%) 
Psoriasis *  3/612 (0.49%)  3/610 (0.49%)  2/300 (0.67%)  3/309 (0.97%) 
Acne *  6/612 (0.98%)  3/610 (0.49%)  2/300 (0.67%)  0/309 (0.00%) 
Pruritus Generalized *  2/612 (0.33%)  4/610 (0.66%)  1/300 (0.33%)  3/309 (0.97%) 
Urticaria *  2/612 (0.33%)  2/610 (0.33%)  3/300 (1.00%)  1/309 (0.32%) 
Dry Skin *  2/612 (0.33%)  5/610 (0.82%)  1/300 (0.33%)  0/309 (0.00%) 
Seborrhoeic Dermatitis *  2/612 (0.33%)  4/610 (0.66%)  2/300 (0.67%)  0/309 (0.00%) 
Intertrigo *  2/612 (0.33%)  3/610 (0.49%)  1/300 (0.33%)  0/309 (0.00%) 
*
Indicates events were collected by non-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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Bausch Health
Phone: 510-259-5284
Layout table for additonal information
Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT01708603    
Other Study ID Numbers: 20120103
First Submitted: September 12, 2012
First Posted: October 17, 2012
Results First Submitted: October 31, 2016
Results First Posted: January 6, 2020
Last Update Posted: January 6, 2020