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Study of AA4500 in the Treatment of Peyronie's Disease

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ClinicalTrials.gov Identifier: NCT01221623
Recruitment Status : Completed
First Posted : October 15, 2010
Results First Posted : April 7, 2015
Last Update Posted : October 5, 2017
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Peyronie's Disease
Interventions Biological: AA4500
Biological: Placebo
Enrollment 418
Recruitment Details  
Pre-assignment Details Includes all subjects who were randomized and received at least 1 dose of study drug; subjects who were randomized but not treated were excluded from the population.
Arm/Group Title AA4500 Placebo
Hide Arm/Group Description

collagenase clostridium histolyticum

AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.

Placebo

Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.

Period Title: Overall Study
Started 274 141
Completed 236 127
Not Completed 38 14
Reason Not Completed
Withdrawal by Subject             19             8
Lost to Follow-up             7             1
Adverse Event             6             3
Death             1             0
Other             5             2
Arm/Group Title AA4500 Placebo Total
Hide Arm/Group Description

collagenase clostridium histolyticum

AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.

Placebo

Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.

Total of all reporting groups
Overall Number of Baseline Participants 274 141 415
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 274 participants 141 participants 415 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
225
  82.1%
112
  79.4%
337
  81.2%
>=65 years
49
  17.9%
29
  20.6%
78
  18.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 274 participants 141 participants 415 participants
57.3  (8.77) 57.6  (7.52) 57.4  (8.36)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 274 participants 141 participants 415 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
274
 100.0%
141
 100.0%
415
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 274 participants 141 participants 415 participants
United States 234 124 358
Australia 40 17 57
1.Primary Outcome
Title Percentage Change From Baseline in Penile Curvature
Hide Description A negative value in the percentage change from baseline in penile curvature deformity (angle measured in degrees) indicates less curvature.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy is based on the modified intent-to-treat (mITT) population.
Arm/Group Title AA4500 Placebo
Hide Arm/Group Description:

collagenase clostridium histolyticum

AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.

Placebo

Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.

Overall Number of Participants Analyzed 202 107
Mean (Standard Deviation)
Unit of Measure: percentage of curvature change
-30.5  (27.7) -15.2  (28.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AA4500, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .0059
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline in the Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ)
Hide Description Peyronie's disease bother score range 0 (no issue or not at all bothered) to 4 (extremely bothered) on 4 questions; total score range 0 to 16. A decrease in the change from baseline total score in the Peyronie's disease bother domain of the PDQ is indicated by a negative number.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy is based on the mITT population.
Arm/Group Title AA4500 Placebo
Hide Arm/Group Description:

collagenase clostridium histolyticum

AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.

Placebo

Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.

Overall Number of Participants Analyzed 202 107
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.4  (3.62) -1.6  (3.52)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AA4500, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .0496
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
3.Secondary Outcome
Title A Responder Analysis Based on Subject Overall Global Assessment
Hide Description Subject overall global assessment of Peyronie's disease score range -3 (much worse) to 3 (much improved). A score of 1 (improved in a small but important way), 2 (moderately improved), or 3 indicated a responder.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy is based on the mITT population.
Arm/Group Title AA4500 Placebo
Hide Arm/Group Description:

collagenase clostridium histolyticum

AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.

Placebo

Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.

Overall Number of Participants Analyzed 202 107
Measure Type: Number
Unit of Measure: participants
Responder Status - No 90 75
Responder Status - Yes 112 32
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AA4500, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in the Severity of Peyronie's Disease Symptoms Domain of the PDQ
Hide Description Peyronie's disease symptoms (physical and psychological) severity score range 0 (none) to 4 (very severe) on 6 questions; total score range 0 to 24. A decrease in the change from baseline total score in the Peyronie's disease symptoms domain of the PDQ is indicated by a negative number.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy is based on the mITT population.
Arm/Group Title AA4500 Placebo
Hide Arm/Group Description:

collagenase clostridium histolyticum

AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.

Placebo

Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.

Overall Number of Participants Analyzed 202 107
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.6  (4.83) -1.0  (4.78)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AA4500, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .0340
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
5.Secondary Outcome
Title Change in the Overall Satisfaction Domain of the International Index of Erectile Function (IIEF)
Hide Description Overall satisfaction domain of the IIEF score range 0 to 5 on 2 questions where higher scores indicate improved function or satisfaction; total score range 0 to 10.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy is based on the mITT population.
Arm/Group Title AA4500 Placebo
Hide Arm/Group Description:

collagenase clostridium histolyticum

AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.

Placebo

Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.

Overall Number of Participants Analyzed 202 107
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.0  (2.33) 0.3  (2.35)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AA4500, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .1168
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Penile Plaque Consistency
Hide Description Penile plaque consistency score range 1 (non-palpable) to 5 (hard). A decrease in the change from baseline score in penile plaque consistency is indicated by a negative number.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy is based on the mITT population.
Arm/Group Title AA4500 Placebo
Hide Arm/Group Description:

collagenase clostridium histolyticum

AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.

Placebo

Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.

Overall Number of Participants Analyzed 202 107
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.8  (0.97) -0.4  (0.86)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AA4500, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .0144
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Penile Length
Hide Description A negative value represents a reduction in measurement from baseline.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy is based on the mITT population.
Arm/Group Title AA4500 Placebo
Hide Arm/Group Description:

collagenase clostridium histolyticum

AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.

Placebo

Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.

Overall Number of Participants Analyzed 202 107
Mean (Standard Deviation)
Unit of Measure: centimeters
0.5  (1.34) 0.2  (1.49)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AA4500, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .0248
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in the Penile Pain Domain of the PDQ in Subjects With Baseline Penile Pain Score ≥4
Hide Description Penile pain scale range 0 (no pain) to 10 (extreme pain) on 3 questions; total score range 0 to 30. A decrease in the change from baseline total score in the penile pain domain of the PDQ is indicated by a negative number. Subjects were required to have a penile pain score of 4 or greater at baseline.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy is based on the mITT population; this population only includes those subjects in the mITT population with a baseline penile pain score of 4 or greater.
Arm/Group Title AA4500 Placebo
Hide Arm/Group Description:

collagenase clostridium histolyticum

AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.

Placebo

Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.

Overall Number of Participants Analyzed 87 51
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.8  (5.93) -4.5  (5.39)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AA4500, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .6949
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
9.Secondary Outcome
Title A Composite Responder Analysis Based on Change From Baseline in Penile Curvature and in the Peyronie's Disease Bother Score
Hide Description

A composite responder is indicated by

  • a percent reduction from baseline in penile curvature greater than or equal to the threshold, and
  • a reduction from baseline in Peyronie's disease bother score greater than or equal to the threshold, or change in the overall sexual activity within the last 3 months to having vaginal intercourse from no vaginal intercourse at screening.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Composite responder analysis is based on the ITT population.
Arm/Group Title AA4500 Placebo
Hide Arm/Group Description:

collagenase clostridium histolyticum

AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.

Placebo

Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.

Overall Number of Participants Analyzed 274 141
Measure Type: Number
Unit of Measure: participants
Responder - No 143 93
Responder - Yes 105 41
Responder - Missing 26 7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AA4500, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .0249
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AA4500 Placebo
Hide Arm/Group Description

collagenase clostridium histolyticum

AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.

Placebo

Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.

All-Cause Mortality
AA4500 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
AA4500 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/274 (4.38%)      4/141 (2.84%)    
Cardiac disorders     
Hypertrophic cardiomyopathy * 1  1/274 (0.36%)  1 0/141 (0.00%)  0
Atrial fibrillation * 1  2/274 (0.73%)  2 0/141 (0.00%)  0
Gastrointestinal disorders     
Intestinal obstruction * 1  0/274 (0.00%)  0 1/141 (0.71%)  1
Infections and infestations     
Bacteraemia * 1  1/274 (0.36%)  1 0/141 (0.00%)  0
Appendicitis * 1  0/274 (0.00%)  0 1/141 (0.71%)  1
Injury, poisoning and procedural complications     
Joint injury * 1  1/274 (0.36%)  1 0/141 (0.00%)  0
Tibia fracture * 1  1/274 (0.36%)  1 0/141 (0.00%)  0
Fracture of penis * 1  2/274 (0.73%)  2 0/141 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthritis * 1  0/274 (0.00%)  0 1/141 (0.71%)  2
Arthralgia * 1  0/274 (0.00%)  0 1/141 (0.71%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Prostate cancer * 1  1/274 (0.36%)  1 0/141 (0.00%)  0
Rectal cancer metastatic * 1  1/274 (0.36%)  1 0/141 (0.00%)  0
Nervous system disorders     
Syncope * 1  1/274 (0.36%)  1 0/141 (0.00%)  0
Reproductive system and breast disorders     
Penile haematoma * 1  1/274 (0.36%)  1 0/141 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AA4500 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   237/274 (86.50%)      51/141 (36.17%)    
General disorders     
Injection site haematoma * 1  61/274 (22.26%)  85 16/141 (11.35%)  20
Injection site pain * 1  41/274 (14.96%)  59 4/141 (2.84%)  4
Injection site swelling * 1  35/274 (12.77%)  54 2/141 (1.42%)  2
Injury, poisoning and procedural complications     
Contusion * 1  27/274 (9.85%)  40 1/141 (0.71%)  1
Musculoskeletal and connective tissue disorders     
Back pain * 1  9/274 (3.28%)  11 7/141 (4.96%)  9
Reproductive system and breast disorders     
Penile haematoma * 1  165/274 (60.22%)  413 22/141 (15.60%)  29
Penile pain * 1  96/274 (35.04%)  212 8/141 (5.67%)  10
Penile swelling * 1  95/274 (34.67%)  170 2/141 (1.42%)  2
Penile haemorrhage * 1  43/274 (15.69%)  68 1/141 (0.71%)  1
Penile oedema * 1  40/274 (14.60%)  87 0/141 (0.00%)  0
Skin and subcutaneous tissue disorders     
Blood blister * 1  17/274 (6.20%)  20 0/141 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.1)
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: Clinical Trial Coordinator
Organization: Endo Pharmaceuticals, Inc.
EMail: clinicalsite.inquiries@endo.com
Layout table for additonal information
Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01221623    
Other Study ID Numbers: AUX-CC-804
First Submitted: October 8, 2010
First Posted: October 15, 2010
Results First Submitted: February 4, 2015
Results First Posted: April 7, 2015
Last Update Posted: October 5, 2017