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Evaluation of Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections

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ClinicalTrials.gov Identifier: NCT01499277
Recruitment Status : Completed
First Posted : December 26, 2011
Results First Posted : November 9, 2015
Last Update Posted : September 6, 2017
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Complicated Skin and Soft Tissue Infection
Interventions Drug: Ceftaroline fosamil
Drug: Vancomycin
Drug: Aztreonam
Enrollment 802
Recruitment Details Overall, 802 patients were enrolled from 111 centres in 6 regions in this study. The first patient was enrolled on 17 May 2012 and the last patient last visit was on 26 June 2014. Of 802 enrolled participants, 30 did not meet the eligibility criteria and 11 were randomized but not treated.
Pre-assignment Details  
Arm/Group Title Ceftaroline Vancomycin/Aztreonam
Hide Arm/Group Description Ceftaroline fosamil at 600 mg every 8 hours (q8h) Vancomycin Plus Aztreonam
Period Title: Overall Study
Started 506 255
Completed 459 223
Not Completed 47 32
Reason Not Completed
Adverse Event             3             6
Death             3             2
Lost to Follow-up             15             8
Protocol Violation             2             3
Withdrawal by Subject             16             6
Lack of therapeutic response and other             8             7
Arm/Group Title Ceftaroline Vancomycin/Aztreonam Total
Hide Arm/Group Description Ceftaroline fosamil at 600 mg every 8 hours (q8h) Vancomycin Plus Aztreonam Total of all reporting groups
Overall Number of Baseline Participants 506 255 761
Hide Baseline Analysis Population Description
761 randomized patients who received any amount of study therapy. there are 11 patients who are randomized , but didn't receive any study therapy.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 506 participants 255 participants 761 participants
52.6  (16.51) 53.6  (16.25) 52.9  (16.42)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 506 participants 255 participants 761 participants
Female
196
  38.7%
107
  42.0%
303
  39.8%
Male
310
  61.3%
148
  58.0%
458
  60.2%
1.Primary Outcome
Title Clinical Response at Test of Cure (TOC) in Modified Intent-to-treat (MITT) Analysis Set
Hide Description The observed difference in the clinical cure rates at TOC (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Clinical cure rate is measured by comparing the participant's signs and symptoms at TOC visit to those recorded at study baseline.
Time Frame 7 to 20 days after the last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (MITT)
Arm/Group Title Ceftaroline Vancomycin/Aztreonam
Hide Arm/Group Description:
Ceftaroline fosamil at 600 mg every 8 hours (q8h)
Vancomycin Plus Aztreonam
Overall Number of Participants Analyzed 506 255
Measure Type: Number
Unit of Measure: Participant
Clinical cure 396 202
Clinical failure 58 34
indeterminate 52 19
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ceftaroline, Vancomycin/Aztreonam
Comments The primary objective of this study was to determine the noninferiority in the clinical cure rate for ceftaroline compared vancomycin plus azreonam group at TOC in both MITT and CE populations.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A two-sided 95% CI for the observed difference in the primary outcome measures (clinical cure rates) between ceftaroline group and vancomycin plus aztreonam group were calculated in both MITT and CE Populations at the TOC visit. Noninferiority was concluded if the lower limit of the 95% CI was higher than –10% in both MITT and CE Populations.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.95
Confidence Interval (2-Sided) 95%
-6.9 to 5.41
Estimation Comments CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.
2.Primary Outcome
Title Clinical Response at TOC in Clinically Evaluable (CE) Analysis Set
Hide Description The observed difference in the clinical cure rates at TOC (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical cure rate is measured by comparing the participant’s signs and symptoms at TOC visit to those recorded at study baseline.
Time Frame 7 to 20 days after the last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Clinical evaluable (CE)
Arm/Group Title Ceftaroline Vancomycin/Aztreonam
Hide Arm/Group Description:
Ceftaroline fosamil at 600 mg every 8 hours (q8h)
Vancomycin Plus Aztreonam
Overall Number of Participants Analyzed 395 211
Measure Type: Number
Unit of Measure: Participant
Clinical cure 342 180
Clinical failure 53 31
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ceftaroline, Vancomycin/Aztreonam
Comments The primary objective of this study was to determine the noninferiority in the clinical cure rate for ceftaroline compared vancomycin plus azreonam group at TOC in both MITT and CE populations.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A two-sided 95% CI for the observed difference in the primary outcome measures (clinical cure rates) between ceftaroline group and vancomycin plus aztreonam group were calculated in both MITT and CE Populations at the TOC visit. Noninferiority was concluded if the lower limit of the 95% CI was higher than –10% in both MITT and CE Populations. If non-inferioirity was achieved then a test of superioirty was conducted if lower limit of 95% CI for the difference was >0%.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 1.27
Confidence Interval (2-Sided) 95%
-4.32 to 7.48
Estimation Comments CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.
3.Secondary Outcome
Title Per Patient Microbiological Response at TOC in Microbiologically Modified-intent-to-treat (mMITT) Analysis Set
Hide Description Difference in microbiological favorable response rate at TOC in mMITT analysis set. Favorable microbiological response rate is measured by comparing TOC microbiological data to baseline microbiological data. In the absence of TOC microbiological data it is presumed from the clinical response.
Time Frame 7 to 20 days after the last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Microbiologically modified-intent-to-treat (mMITT)
Arm/Group Title Ceftaroline Vancomycin/Aztreonam
Hide Arm/Group Description:
Ceftaroline fosamil at 600 mg every 8 hours (q8h)
Vancomycin Plus Aztreonam
Overall Number of Participants Analyzed 248 136
Measure Type: Number
Unit of Measure: Participant
Favorable 203 109
Unfavorable 17 17
Indeterminate 28 10
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ceftaroline, Vancomycin/Aztreonam
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 1.71
Confidence Interval (2-Sided) 95%
-6.21 to 10.39
Estimation Comments CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.
4.Secondary Outcome
Title Per-patient Micro Response at TOC in Microbiologically Evaluable (ME) Analysis Set
Hide Description Difference in microbiological favorable response rate at TOC in ME. Favourable microbiological response rate is measured by comparing TOC microbiological data to baseline microbiological data. In the absence of TOC microbiological data it is presumed from the clinical response.
Time Frame 7 to 20 days after the last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Microbiologically evaluable (ME)
Arm/Group Title Ceftaroline Vancomycin/Aztreonam
Hide Arm/Group Description:
Ceftaroline fosamil at 600 mg every 8 hours (q8h)
Vancomycin Plus Aztreonam
Overall Number of Participants Analyzed 181 112
Measure Type: Number
Unit of Measure: Participant
Favourable 167 98
Unfavorable 14 14
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ceftaroline, Vancomycin/Aztreonam
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 4.77
Confidence Interval (2-Sided) 95%
-2.11 to 12.86
Estimation Comments CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.
5.Secondary Outcome
Title Clinical Response at End of Treatment (EOT) in MITT Analysis Set
Hide Description The observed difference in the clinical cure rates at EOT (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Clinical cure rate is measured by comparing the participant’s signs and symptoms at EOT visit to those recorded at study baseline.
Time Frame On day of last dose of study drug (or + 1 day)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ceftaroline Vancomycin/Aztreonam
Hide Arm/Group Description:
Ceftaroline fosamil at 600 mg every 8 hours (q8h)
Vancomycin Plus Aztreonam
Overall Number of Participants Analyzed 506 255
Measure Type: Number
Unit of Measure: Participants
Clinical cure 429 213
Clinical failure 44 29
Indeterminate 31 11
Missing 2 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ceftaroline, Vancomycin/Aztreonam
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 1.25
Confidence Interval (2-Sided) 95%
-4.05 to 7.06
Estimation Comments CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.
6.Secondary Outcome
Title Clinical Response at EOT in CE Analysis Set
Hide Description The observed difference in the clinical cure rates at EOT (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical cure rate is measured by comparing the participant’s signs and symptoms at EOT visit to those recorded at study baseline.
Time Frame On day of last dose of study drug (or +1 day)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ceftaroline Vancomycin/Aztreonam
Hide Arm/Group Description:
Ceftaroline fosamil at 600 mg every 8 hours (q8h)
Vancomycin Plus Aztreonam
Overall Number of Participants Analyzed 395 211
Measure Type: Number
Unit of Measure: Participants
Clinical cure 356 184
Clinical failure 39 27
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ceftaroline, Vancomycin/Aztreonam
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 2.92
Confidence Interval (2-Sided) 95%
-2.19 to 8.73
Estimation Comments CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.
7.Secondary Outcome
Title Clinical Relapse at Late Follow-up (LFU) in CE Patients Who Were Cured at TOC
Hide Description The observed difference in the clinical relapse rates at LFU (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical relapse rate at LFU is measured by comparing a patient's signs and symptoms at late follow-up to those when they were cured at TOC.
Time Frame 21 to 42 days after the last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ceftaroline Vancomycin/Aztreonam
Hide Arm/Group Description:
Ceftaroline fosamil at 600 mg every 8 hours (q8h)
Vancomycin Plus Aztreonam
Overall Number of Participants Analyzed 342 180
Measure Type: Number
Unit of Measure: Participants
Relapse 3 3
No relapse 335 174
Indeterminate 3 3
Missing 1 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ceftaroline, Vancomycin/Aztreonam
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.79
Confidence Interval (2-Sided) 95%
-3.98 to 1.18
Estimation Comments CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.
8.Secondary Outcome
Title Early Response at 48 to 72 Hours of Treatment in MITT Analysis Set
Hide Description The observed difference in the early success rates at 48 to 72 hours of treatment (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Early response rate as measured by comparing the participant's signs and symptoms at the 48-72 hour visit to those recorded at study baseline.
Time Frame 48 to 72 hours after first dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ceftaroline Vancomycin/Aztreonam
Hide Arm/Group Description:
Ceftaroline fosamil at 600 mg every 8 hours (q8h)
Vancomycin Plus Aztreonam
Overall Number of Participants Analyzed 506 255
Measure Type: Number
Unit of Measure: Participants
success 445 229
failure 28 11
Indeterminate 33 15
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ceftaroline, Vancomycin/Aztreonam
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -1.86
Confidence Interval (2-Sided) 95%
-6.34 to 3.15
Estimation Comments CI for risk difference was estimated by 95% using unstratified Miettinen and Nurminen CI.
9.Secondary Outcome
Title Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME
Hide Description Per-pathogen microbiological response at TOC by baseline pathogen from site of skin infection in ME analysis set
Time Frame 7 to 20 days after the last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ceftaroline Vancomycin/Aztreonam
Hide Arm/Group Description:
Ceftaroline fosamil at 600 mg every 8 hours (q8h)
Vancomycin Plus Aztreonam
Overall Number of Participants Analyzed 181 112
Measure Type: Number
Unit of Measure: Participants
MSSA - Favorable; (n=94, 57) 91 49
MSSA - Unfavorable; (n=94, 57) 3 8
MRSA - Favorable; (n=25, 15) 22 12
MRSA - Unfavorable; (n=25, 15) 3 3
Streptococcus pyogenes - Favorable; (n=15, 7) 14 7
Streptococcus pyogenes - Unfavorable; (n=15, 7) 1 0
Streptococcus agalactiae - Favorable; (n=6, 9) 6 9
Streptococcus agalactiae - Unfavorable; (n=6, 9) 0 0
Streptococcus dysgalactiae - Favorable; (n=9, 0) 9 0
Streptococcus dysgalactiae - Unfavorable; (n=9, 0) 0 0
Enterococcus faecalis - Favorable; (n=6, 5) 5 4
Enterococcus faecalis - Unfavorable; (n=6, 5) 1 1
Escherichia coli - Favorable; (n=12, 10) 12 9
Escherichia coli - Unfavorable; (n=12, 10) 0 1
Klebsiella pneumoniae - Favorable; (n=7, 4) 6 3
Klebsiella pneumoniae - Unfavorable; (n=7, 4) 1 1
Klebsiella oxytoca - Favorable; (n=4, 1) 4 1
Klebsiella oxytoca - Unfavorable; (n=4, 1) 0 0
Proteus mirabilis - Favorable; (n=7, 2) 6 2
Proteus mirabilis - Unfavorable; (n=7, 2) 1 0
Morganella morganii - Favorable; (n=4, 2) 4 2
Morganella morganii - Unfavorable; (n=4, 2) 0 0
Enterobacter cloacae - Favorable; (n=4, 5) 4 5
Enterobacter cloacae - Unfavorable; (n=4, 5) 0 0
Time Frame Adverse events were collected from time of the first dose of study drug up to TOC visit (8 to 15 days after the last dose). Serious AEs were collected from time of signature of informed consent up to the LFU visit (21 to 35 days after the last dose).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ceftaroline Vancomycin/Aztreonam
Hide Arm/Group Description Ceftaroline fosamil at 600 mg every 8 hours (q8h) Vancomycin Plus Aztreonam
All-Cause Mortality
Ceftaroline Vancomycin/Aztreonam
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ceftaroline Vancomycin/Aztreonam
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   31/506 (6.13%)      15/255 (5.88%)    
Cardiac disorders     
Atrial fibrillation  1  1/506 (0.20%)  1 0/255 (0.00%)  0
Cardiac failure  1  3/506 (0.59%)  3 0/255 (0.00%)  0
Cardiac failure congestive  1  0/506 (0.00%)  0 1/255 (0.39%)  1
Cardiomyopathy  1  1/506 (0.20%)  1 0/255 (0.00%)  0
Coronary artery disease  1  1/506 (0.20%)  1 0/255 (0.00%)  0
Myocardial infarction  1  1/506 (0.20%)  1 1/255 (0.39%)  1
Ventricular tachycardia  1  0/506 (0.00%)  0 0/255 (0.00%)  0
Gastrointestinal disorders     
Anal fistula  1  1/506 (0.20%)  1 0/255 (0.00%)  0
Large intestine perforation  1  1/506 (0.20%)  1 0/255 (0.00%)  0
Pancreatitis acute  1  1/506 (0.20%)  1 0/255 (0.00%)  0
Upper gastrointestinal haemorrhage  1  0/506 (0.00%)  0 1/255 (0.39%)  1
General disorders     
Generalised oedema  1  1/506 (0.20%)  1 0/255 (0.00%)  0
Pyrexia  1  0/506 (0.00%)  0 1/255 (0.39%)  1
Immune system disorders     
Drug hypersensitivity  1  1/506 (0.20%)  1 0/255 (0.00%)  0
Infections and infestations     
Abdominal infection  1  1/506 (0.20%)  1 0/255 (0.00%)  0
Abscess limb  1  1/506 (0.20%)  1 0/255 (0.00%)  0
Bronchopneumonia  1  0/506 (0.00%)  0 1/255 (0.39%)  1
Diabetic gangrene  1  0/506 (0.00%)  0 1/255 (0.39%)  1
Gangrene  1  0/506 (0.00%)  0 1/255 (0.39%)  1
Gastroenteritis  1  1/506 (0.20%)  1 0/255 (0.00%)  0
Lung infection  1  1/506 (0.20%)  1 0/255 (0.00%)  0
Pneumonia  1  2/506 (0.40%)  2 0/255 (0.00%)  0
Pneumonia staphylococcal  1  0/506 (0.00%)  0 1/255 (0.39%)  1
Sepsis  1  1/506 (0.20%)  1 0/255 (0.00%)  0
Wound infection  1  1/506 (0.20%)  1 0/255 (0.00%)  0
Injury, poisoning and procedural complications     
Metal poisoning  1  1/506 (0.20%)  1 0/255 (0.00%)  0
Toxicity to various agents  1  1/506 (0.20%)  1 0/255 (0.00%)  0
Investigations     
Hepatic enzyme increased  1  1/506 (0.20%)  1 0/255 (0.00%)  0
Metabolism and nutrition disorders     
Hypokalaemia  1  1/506 (0.20%)  1 0/0  0
Nervous system disorders     
Dizziness  1  1/506 (0.20%)  1 0/255 (0.00%)  0
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous  1  1/506 (0.20%)  1 0/255 (0.00%)  0
Psychiatric disorders     
Alcohol withdrawal syndrome  1  0/506 (0.00%)  0 1/1 (100.00%)  1
Confusional state  1  0/506 (0.00%)  0 1/255 (0.39%)  1
Renal and urinary disorders     
Nephropathy toxic  1  0/506 (0.00%)  0 1/255 (0.39%)  1
Renal failure acute  1  1/506 (0.20%)  1 2/255 (0.78%)  2
Respiratory, thoracic and mediastinal disorders     
Pneumonia aspiration  1  1/506 (0.20%)  1 0/255 (0.00%)  0
Pulmonary embolism  1  0/506 (0.00%)  0 1/255 (0.39%)  1
Pulmonary haemosiderosis  1  0/506 (0.00%)  0 1/255 (0.39%)  1
Pulmonary oedema  1  0/506 (0.00%)  0 1/255 (0.39%)  1
Respiratory failure  1  0/506 (0.00%)  0 1/255 (0.39%)  1
Skin and subcutaneous tissue disorders     
Drug eruption  1  1/506 (0.20%)  1 0/255 (0.00%)  0
Toxic epidermal necrolysis  1  1/506 (0.20%)  1 0/255 (0.00%)  0
Urticaria  1  1/506 (0.20%)  1 1/255 (0.39%)  1
Vascular disorders     
Deep vein thrombosis  1  2/506 (0.40%)  2 1/255 (0.39%)  1
Hypertension  1  0/506 (0.00%)  0 1/255 (0.39%)  1
Peripheral arterial occlusive disease  1  1/506 (0.20%)  1 0/255 (0.00%)  0
Venous thrombosis  1  1/506 (0.20%)  1 0/255 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Ceftaroline Vancomycin/Aztreonam
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   82/506 (16.21%)      46/255 (18.04%)    
Blood and lymphatic system disorders     
Anaemia  1  10/506 (1.98%)  10 9/255 (3.53%)  9
Gastrointestinal disorders     
Constipation  1  9/506 (1.78%)  9 8/255 (3.14%)  8
Diarrhoea  1  12/506 (2.37%)  12 5/255 (1.96%)  5
Nausea  1  20/506 (3.95%)  20 11/255 (4.31%)  11
Vomiting  1  13/506 (2.57%)  15 5/255 (1.96%)  5
Metabolism and nutrition disorders     
Hypokalaemia  1  14/506 (2.77%)  14 8/255 (3.14%)  9
Nervous system disorders     
Headache  1  17/506 (3.36%)  17 12/255 (4.71%)  13
Skin and subcutaneous tissue disorders     
Rash  1  10/506 (1.98%)  11 6/255 (2.35%)  6
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
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 investigator agrees not to use such Confidential study information and not to disclose them to any other third parties, except that the undersigned shall not be prevented from using or disclosing information: (a) which by written records was previously known; (b) which is now public knowledge, (c) which is lawfully obtained by the undersigned from sources who have a lawful right to disclose such information.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Yunxia Lu
Organization: AstraZeneca-PPD
Phone: 910-558-4197
EMail: Yunxia.Lu@ppdi.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01499277     History of Changes
Other Study ID Numbers: D3720C00001
2011-004013-16
First Submitted: December 16, 2011
First Posted: December 26, 2011
Results First Submitted: June 23, 2015
Results First Posted: November 9, 2015
Last Update Posted: September 6, 2017