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Phase II Trial to Compare the Safety of Two Chemotherapy Plus Trastuzumab Regimens as Adjuvant Therapy for HER2-positive Breast Cancer (Study P05048)

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ClinicalTrials.gov Identifier: NCT00550771
Recruitment Status : Completed
First Posted : October 30, 2007
Results First Posted : October 3, 2011
Last Update Posted : June 7, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Neoplasm
Interventions Drug: doxorubicin, cyclophosphamide, paclitaxel, trastuzumab
Drug: PLD, cyclophosphamide, trastuzumab, paclitaxel
Enrollment 181
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pegylated Liposomal Doxorubicin (PLD) Based Regimen Doxorubicin Based Regimen
Hide Arm/Group Description PLD 35 mg/m^2 IV over 60 minutes + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses) doxorubicin 60 mg/m^2 intravenous (IV) push + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)
Period Title: Overall Study
Started 121 60
Completed 104 50
Not Completed 17 10
Reason Not Completed
Adverse Event             11             3
Discontinued for study-related reasons             0             1
Physician Decision             2             0
Withdrawal by Subject             0             1
Protocol Violation             4             5
Arm/Group Title Pegylated Liposomal Doxorubicin (PLD) Based Regimen Doxorubicin Based Regimen Total
Hide Arm/Group Description PLD 35 mg/m^2 IV over 60 minutes + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses) doxorubicin 60 mg/m^2 intravenous (IV) push + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses) Total of all reporting groups
Overall Number of Baseline Participants 120 59 179
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 120 participants 59 participants 179 participants
50.2  (10.97) 52.5  (9.32) 50.9  (10.49)
[1]
Measure Description: Age information was for the intent-to-treat (ITT) population (n=59 for doxorubicin arm, n=120 for PLD arm). ITT was defined as all participants who were randomized and received at least 1 dose of any study medication.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants 59 participants 179 participants
Female
120
 100.0%
59
 100.0%
179
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: ITT population.
1.Primary Outcome
Title Number of Participants Who Experienced Cardiac Events (Level 1 or 2), or Inability to Administer Trastuzumab Either During the 8 Cycles of Chemotherapy or According to Package Insert for a Total Duration of 1 Year
Hide Description

Cardiac events defined as:

Level 1: Cardiac death due to heart failure (HF), myocardial infarction or arrhythmia, or probable cardiac death defined as sudden, unexpected death within 24 hours of a definite or probable cardiac event, or severe symptomatic HF, concomitant with a left ventricular ejection fraction (LVEF) drop of >10 percentage points from baseline and to ≤50% LVEF

Level 2: Asymptomatic systolic dysfunction or mildly symptomatic HF concomitant with an LVEF drop of >10 percentage points from baseline and to <50% LVEF; the LVEF drop was to have been confirmed within 3-4 weeks.

Time Frame 8 cycles of chemotherapy and subsequently one year of planned trastuzumab treatment
Hide Outcome Measure Data
Hide Analysis Population Description

ITT, defined as all participants who were randomized and received at least 1 dose of any study medication.

Each participant could not contribute more than 1 event.

Arm/Group Title Pegylated Liposomal Doxorubicin (PLD) Based Regimen Doxorubicin Based Regimen
Hide Arm/Group Description:
PLD 35 mg/m^2 IV over 60 minutes + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)
doxorubicin 60 mg/m^2 intravenous (IV) push + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)
Overall Number of Participants Analyzed 120 59
Measure Type: Number
Unit of Measure: Participants
5 11
2.Secondary Outcome
Title Number of Participants Who Experienced Cardiac Events (Level 1 or 2) or Inability to Administer Trastuzumab During the 8 Cycles of Chemotherapy
Hide Description

Cardiac events defined as:

Level 1: Cardiac death due to heart failure (HF), myocardial infarction or arrhythmia, or probable cardiac death defined as sudden, unexpected death within 24 hours of a definite or probable cardiac event, or severe symptomatic HF, concomitant with a left ventricular ejection fraction (LVEF) drop of >10 percentage points from baseline and to ≤50% LVEF

Level 2: Asymptomatic systolic dysfunction or mildly symptomatic HF concomitant with an LVEF drop of >10 percentage points from baseline and to <50% LVEF; the LVEF drop was to have been confirmed within 3-4 weeks.

Time Frame During the 8 courses of chemotherapy
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, defined as all participants who were randomized and received at least 1 dose of any study medication.
Arm/Group Title Pegylated Liposomal Doxorubicin (PLD) Based Regimen Doxorubicin Based Regimen
Hide Arm/Group Description:
PLD 35 mg/m^2 IV over 60 minutes + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)
doxorubicin 60 mg/m^2 intravenous (IV) push + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)
Overall Number of Participants Analyzed 120 59
Measure Type: Number
Unit of Measure: Participants
Level 1 Cardiotoxicity 1 0
Level 2 Cardiotoxicity 1 3
Inability to Administer Trastuzumab 0 0
3.Secondary Outcome
Title Number of Participants Who Experienced Cardiac Events (Level 1 or 2) or Inability to Administer Trastuzumab During 1 Year of Trastuzumab Therapy
Hide Description

Cardiac events defined as:

Level 1: Cardiac death due to heart failure (HF), myocardial infarction or arrhythmia, or probable cardiac death defined as sudden, unexpected death within 24 hours of a definite or probable cardiac event, or severe symptomatic HF, concomitant with a left ventricular ejection fraction (LVEF) drop of >10 percentage points from baseline and to ≤50% LVEF

Level 2: Asymptomatic systolic dysfunction or mildly symptomatic HF concomitant with an LVEF drop of >10 percentage points from baseline and to <50% LVEF; the LVEF drop was to have been confirmed within 3-4 weeks.

Time Frame During 1 year of trastuzumab therapy
Hide Outcome Measure Data
Hide Analysis Population Description
ITT, defined as all participants who were randomized and received at least 1 dose of any study medication.
Arm/Group Title Pegylated Liposomal Doxorubicin (PLD) Based Regimen Doxorubicin Based Regimen
Hide Arm/Group Description:
PLD 35 mg/m^2 IV over 60 minutes + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)
doxorubicin 60 mg/m^2 intravenous (IV) push + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)
Overall Number of Participants Analyzed 116 52
Measure Type: Number
Unit of Measure: Participants
Level 1 Cardiotoxicity 1 0
Level 2 Cardiotoxicity 4 10
Inability to Administer Trastuzumab 4 8
4.Secondary Outcome
Title Number of Participants Who Survived Without Relapse
Hide Description

Relapse-free survival would have been determined by Kaplan-Meier method.

This was not calculated, since the 2 year follow-up was curtailed.

Time Frame Approximately 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pegylated Liposomal Doxorubicin (PLD) Based Regimen Doxorubicin Based Regimen
Hide Arm/Group Description:
PLD 35 mg/m^2 IV over 60 minutes + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)
doxorubicin 60 mg/m^2 intravenous (IV) push + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PLD Based Regimen Doxorubicin Based Regimen
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
PLD Based Regimen Doxorubicin Based Regimen
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
PLD Based Regimen Doxorubicin Based Regimen
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/120 (16.67%)      7/59 (11.86%)    
Blood and lymphatic system disorders     
ANAEMIA  1  1/120 (0.83%)  1 1/59 (1.69%)  1
FEBRILE NEUTROPENIA  1  5/120 (4.17%)  6 4/59 (6.78%)  5
LEUKOPENIA  1  1/120 (0.83%)  1 0/59 (0.00%)  0
NEUTROPENIA  1  0/120 (0.00%)  0 2/59 (3.39%)  2
Cardiac disorders     
ATRIAL THROMBOSIS  1  1/120 (0.83%)  1 0/59 (0.00%)  0
CARDIAC FAILURE  1  1/120 (0.83%)  1 1/59 (1.69%)  1
MITRAL VALVE INCOMPETENCE  1  0/120 (0.00%)  0 1/59 (1.69%)  1
MYOCARDIAL INFARCTION  1  1/120 (0.83%)  1 0/59 (0.00%)  0
PLEUROPERICARDITIS  1  1/120 (0.83%)  1 0/59 (0.00%)  0
Gastrointestinal disorders     
ABDOMINAL PAIN  1  0/120 (0.00%)  0 1/59 (1.69%)  1
ABDOMINAL PAIN UPPER  1  1/120 (0.83%)  1 0/59 (0.00%)  0
DIARRHOEA  1  1/120 (0.83%)  1 0/59 (0.00%)  0
GASTRIC ULCER PERFORATION  1  1/120 (0.83%)  1 0/59 (0.00%)  0
NAUSEA  1  1/120 (0.83%)  1 2/59 (3.39%)  2
PANCREATITIS  1  0/120 (0.00%)  0 1/59 (1.69%)  1
VOMITING  1  0/120 (0.00%)  0 2/59 (3.39%)  2
General disorders     
INFLUENZA LIKE ILLNESS  1  1/120 (0.83%)  1 0/59 (0.00%)  0
MALAISE  1  0/120 (0.00%)  0 2/59 (3.39%)  2
MUCOSAL INFLAMMATION  1  0/120 (0.00%)  0 1/59 (1.69%)  1
PAIN  1  0/120 (0.00%)  0 1/59 (1.69%)  1
PYREXIA  1  7/120 (5.83%)  9 2/59 (3.39%)  2
Infections and infestations     
CELLULITIS  1  1/120 (0.83%)  1 0/59 (0.00%)  0
DEVICE RELATED INFECTION  1  1/120 (0.83%)  1 0/59 (0.00%)  0
DEVICE RELATED SEPSIS  1  0/120 (0.00%)  0 1/59 (1.69%)  1
LOCALISED INFECTION  1  0/120 (0.00%)  0 1/59 (1.69%)  1
PNEUMONIA  1  1/120 (0.83%)  1 0/59 (0.00%)  0
URINARY TRACT INFECTION  1  0/120 (0.00%)  0 1/59 (1.69%)  1
UROSEPSIS  1  0/120 (0.00%)  0 1/59 (1.69%)  1
Nervous system disorders     
LETHARGY  1  0/120 (0.00%)  0 1/59 (1.69%)  1
Respiratory, thoracic and mediastinal disorders     
COUGH  1  1/120 (0.83%)  1 1/59 (1.69%)  2
OROPHARYNGEAL PAIN  1  0/120 (0.00%)  0 1/59 (1.69%)  1
PNEUMOTHORAX  1  1/120 (0.83%)  1 0/59 (0.00%)  0
Skin and subcutaneous tissue disorders     
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME  1  2/120 (1.67%)  2 0/59 (0.00%)  0
SKIN ULCER  1  0/120 (0.00%)  0 1/59 (1.69%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PLD Based Regimen Doxorubicin Based Regimen
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   115/120 (95.83%)      58/59 (98.31%)    
Blood and lymphatic system disorders     
ANAEMIA  1  6/120 (5.00%)  10 6/59 (10.17%)  8
LEUKOPENIA  1  8/120 (6.67%)  18 4/59 (6.78%)  16
LYMPHOPENIA  1  2/120 (1.67%)  12 3/59 (5.08%)  3
NEUTROPENIA  1  27/120 (22.50%)  72 26/59 (44.07%)  37
Cardiac disorders     
PALPITATIONS  1  12/120 (10.00%)  17 4/59 (6.78%)  7
Eye disorders     
DRY EYE  1  3/120 (2.50%)  3 4/59 (6.78%)  4
LACRIMATION INCREASED  1  11/120 (9.17%)  12 6/59 (10.17%)  6
Gastrointestinal disorders     
ABDOMINAL PAIN  1  8/120 (6.67%)  13 7/59 (11.86%)  10
ABDOMINAL PAIN UPPER  1  8/120 (6.67%)  8 7/59 (11.86%)  10
CONSTIPATION  1  31/120 (25.83%)  45 20/59 (33.90%)  38
DIARRHOEA  1  34/120 (28.33%)  65 17/59 (28.81%)  33
DRY MOUTH  1  1/120 (0.83%)  1 3/59 (5.08%)  3
DYSPEPSIA  1  24/120 (20.00%)  35 4/59 (6.78%)  5
HAEMORRHOIDS  1  6/120 (5.00%)  7 4/59 (6.78%)  5
NAUSEA  1  63/120 (52.50%)  100 35/59 (59.32%)  70
STOMATITIS  1  28/120 (23.33%)  41 13/59 (22.03%)  18
VOMITING  1  27/120 (22.50%)  37 13/59 (22.03%)  22
General disorders     
ASTHENIA  1  30/120 (25.00%)  72 11/59 (18.64%)  27
CHEST PAIN  1  7/120 (5.83%)  8 2/59 (3.39%)  5
FATIGUE  1  51/120 (42.50%)  102 36/59 (61.02%)  71
INFLUENZA LIKE ILLNESS  1  3/120 (2.50%)  5 4/59 (6.78%)  4
MALAISE  1  0/120 (0.00%)  0 4/59 (6.78%)  9
MUCOSAL INFLAMMATION  1  41/120 (34.17%)  82 16/59 (27.12%)  21
OEDEMA  1  6/120 (5.00%)  7 5/59 (8.47%)  7
OEDEMA PERIPHERAL  1  23/120 (19.17%)  31 11/59 (18.64%)  13
PAIN  1  3/120 (2.50%)  5 3/59 (5.08%)  3
PYREXIA  1  19/120 (15.83%)  28 10/59 (16.95%)  14
Immune system disorders     
HYPERSENSITIVITY  1  9/120 (7.50%)  16 3/59 (5.08%)  3
Infections and infestations     
NASOPHARYNGITIS  1  9/120 (7.50%)  9 6/59 (10.17%)  6
SINUSITIS  1  1/120 (0.83%)  1 3/59 (5.08%)  3
Investigations     
WEIGHT INCREASED  1  23/120 (19.17%)  26 14/59 (23.73%)  23
Metabolism and nutrition disorders     
DECREASED APPETITE  1  29/120 (24.17%)  38 14/59 (23.73%)  26
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  6/120 (5.00%)  8 7/59 (11.86%)  12
BACK PAIN  1  11/120 (9.17%)  13 1/59 (1.69%)  1
BONE PAIN  1  5/120 (4.17%)  9 3/59 (5.08%)  4
MUSCULOSKELETAL PAIN  1  7/120 (5.83%)  7 4/59 (6.78%)  6
MYALGIA  1  20/120 (16.67%)  26 14/59 (23.73%)  20
PAIN IN EXTREMITY  1  5/120 (4.17%)  5 5/59 (8.47%)  5
Nervous system disorders     
DISTURBANCE IN ATTENTION  1  1/120 (0.83%)  1 3/59 (5.08%)  3
DIZZINESS  1  11/120 (9.17%)  16 11/59 (18.64%)  14
DYSGEUSIA  1  16/120 (13.33%)  27 8/59 (13.56%)  15
HEADACHE  1  18/120 (15.00%)  30 11/59 (18.64%)  20
NEUROPATHY PERIPHERAL  1  11/120 (9.17%)  13 8/59 (13.56%)  12
NEUROTOXICITY  1  7/120 (5.83%)  12 4/59 (6.78%)  5
PARAESTHESIA  1  10/120 (8.33%)  12 5/59 (8.47%)  6
PERIPHERAL MOTOR NEUROPATHY  1  2/120 (1.67%)  2 5/59 (8.47%)  8
PERIPHERAL SENSORY NEUROPATHY  1  16/120 (13.33%)  35 9/59 (15.25%)  18
Psychiatric disorders     
ANXIETY  1  10/120 (8.33%)  11 2/59 (3.39%)  2
DEPRESSION  1  4/120 (3.33%)  5 4/59 (6.78%)  4
INSOMNIA  1  15/120 (12.50%)  18 7/59 (11.86%)  9
Renal and urinary disorders     
DYSURIA  1  4/120 (3.33%)  4 4/59 (6.78%)  4
Respiratory, thoracic and mediastinal disorders     
COUGH  1  19/120 (15.83%)  24 16/59 (27.12%)  19
DYSPNOEA  1  27/120 (22.50%)  34 12/59 (20.34%)  21
EPISTAXIS  1  26/120 (21.67%)  36 12/59 (20.34%)  16
OROPHARYNGEAL PAIN  1  10/120 (8.33%)  13 1/59 (1.69%)  1
RHINORRHOEA  1  8/120 (6.67%)  10 5/59 (8.47%)  5
Skin and subcutaneous tissue disorders     
ALOPECIA  1  59/120 (49.17%)  75 45/59 (76.27%)  55
DRY SKIN  1  4/120 (3.33%)  4 5/59 (8.47%)  5
ERYTHEMA  1  18/120 (15.00%)  29 2/59 (3.39%)  3
NAIL DISORDER  1  5/120 (4.17%)  6 6/59 (10.17%)  6
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME  1  79/120 (65.83%)  183 3/59 (5.08%)  3
RASH  1  35/120 (29.17%)  68 6/59 (10.17%)  8
SKIN HYPERPIGMENTATION  1  7/120 (5.83%)  8 0/59 (0.00%)  0
Vascular disorders     
FLUSHING  1  7/120 (5.83%)  8 2/59 (3.39%)  2
HOT FLUSH  1  10/120 (8.33%)  13 5/59 (8.47%)  6
HYPERTENSION  1  4/120 (3.33%)  5 3/59 (5.08%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Any follow-up data from this study should be considered with caution as the planned 2-year follow-up was curtailed because of administrative reasons.
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 principal investigators (PIs) agree not to publish/publicly present any interim study results without prior sponsor written consent. The PIs further agree to provide 45 days written notice to the sponsor, prior to submission for publication or presentation, to permit the sponsor to review abstracts/manuscripts, which report any study results. The sponsor has the right to review/comment. If the parties disagree, the PIs agree to meet with the sponsor, prior to submission, to discuss/resolve.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00550771     History of Changes
Other Study ID Numbers: P05048
First Submitted: October 29, 2007
First Posted: October 30, 2007
Results First Submitted: August 26, 2011
Results First Posted: October 3, 2011
Last Update Posted: June 7, 2017