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Single-Dose And Multiple-Dose Safety And Tolerability Study Of PF-04856883 In Type 2 Diabetic Adult Females

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ClinicalTrials.gov Identifier: NCT01301456
Recruitment Status : Completed
First Posted : February 23, 2011
Results First Posted : February 9, 2018
Last Update Posted : February 9, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE February 9, 2011
First Posted Date  ICMJE February 23, 2011
Results First Submitted Date  ICMJE April 13, 2017
Results First Posted Date  ICMJE February 9, 2018
Last Update Posted Date February 9, 2018
Actual Study Start Date  ICMJE March 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2017)
  • Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50 ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose (Day 50) that were absent before treatment or that worsened relative to pretreatment state.
  • Number of Participants With Clinically Significant Physical Examination Findings [ Time Frame: Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50 ]
    Physical examination included examination of general appearance, head, ears, eyes (including fundoscopy), nose, mouth, throat, neck (including thyroid), skin, breast (optional), cardiac, respiratory, gastrointestinal, musculoskeletal and neurological systems.
  • Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) [ Time Frame: Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50 ]
    ECG parameters included pulse rate (PR) interval, QRS interval, corrected QT interval using Bazett's formula (QTcB) and corrected QT interval using Fridericia's formula (QTcF). ECG criteria of clinically significant concern were 1) PR interval: greater than equal to (>=) 25 percent (%) increase when baseline greater than (>)200 milliseconds (msec); or increase >=50% when baseline less than or equal to (<=200) msec; 2) QRS interval: >=25% increase when baseline >100 msec; >=50% increase when baseline <= 100 msec; 3) QTCF interval: QTc interval using Fridericia's formula (QTcF interval) and Bazett's formula (QTcB interval): absolute value 450 - <480 msec, 480 - <500 msec >=500; absolute change 30 - <60, >=60 msec. The number of participants with potentially clinically significant ECG findings at any visit were reported. IFB = increase from baseline.
  • Number of Participants With Vital Sign Abnormalities [ Time Frame: Stage 1: Baseline up to Day 29; Stage 2 : Baseline up to Day 50 ]
    Criteria for vital signs abnormalities: sitting/supine systolic pulse rate less than (<) 40 beats per minute (bpm) or greater than (>) 120 bpm, standing/supine systolic pulse < 40 bpm or > 140 bpm, systolic blood pressure of >=30 millimeters of mercury (mmHg) change from baseline and systolic blood pressure <90 mmHg, diastolic blood pressure >=20 mmHg change from baseline and diastolic blood pressure <50 mm Hg.
  • Number of Participants With Clinically Significant Abnormalities in Laboratory Measurements [ Time Frame: Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50 ]
    Following parameters were analyzed for laboratory examination: Hematology: hemoglobin, hematocrit, red blood cell (RBC) <0.8*lower limit of the reference range (LLRR); leukocytes <0.6*LLRR or >1.5*ULRR; platelet count <0.5*LLRR or >1.75*upper limit of the reference range (ULRR); total neutrophils (absolute [abs]), lymphocytes (abs) <0.8*LLRR or >1.2*ULRR; eosinophils (abs), basophils (abs), monocytes (abs) >1.2*ULRR; chemistry (total bilirubin, direct bilirubin, indirect bilirubin >1.5*ULRR; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase >3*ULRR, albumin, total protein <0.8*LLRR or >1.2*ULRR; blood urea nitrogen (BUN), creatinine >1.3*ULRR; glucose (fasting) <0.6*LLRR or >1.5*ULRR; uric acid >1.2* ULRR; sodium <0.95*LLRR or >1.05*ULRR; potassium, chloride, bicarbonate, calcium <0.9*LLRR or >1.1*ULRR. Urinalysis: Urine white blood cell (WBC), Urine RBC =>20/ high-power field (HPF).
Original Primary Outcome Measures  ICMJE
 (submitted: February 21, 2011)
  • Number of participants with adverse events (Stage 1 and Stage 2) [ Time Frame: 4 weeks for Stage 1; 7 weeks for Stage 2 ]
  • Number of participants with abnormal physical examinations (Stage 1 and Stage 2) [ Time Frame: 4 weeks for Stage 1; 7 weeks for Stage 2 ]
  • Number of participants with abnormal 12-lead electrocardiograms (Stage 1 and Stage 2) [ Time Frame: 4 weeks for Stage 1; 7 weeks for Stage 2 ]
  • Number of participants with abnormal vital signs (Stage 1 and Stage 2) [ Time Frame: 4 weeks for Stage 1; 7 weeks for Stage 2 ]
  • Number of participants with abnormal safety laboratory measurements (Stage 1 and Stage 2) [ Time Frame: 4 weeks for Stage 1; 7 weeks for Stage 2 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2017)
  • Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 1 [ Time Frame: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1 ]
  • Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 2 [ Time Frame: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336 hours postdose on Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22 ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 1 [ Time Frame: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1 ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 2 [ Time Frame: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336 hours postdose on Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22 ]
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) of PF-04856883: Stage 1 [ Time Frame: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1 ]
    AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
  • Area Under the Concentration Time Curve From Time Zero to Time Tau (AUCtau) of PF-04856883: Stage 2 [ Time Frame: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168 hours postdose Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168 hours postdose Day 22 ]
    Area under the serum concentration-time curve from time 0 to tau (AUCtau), where tau was the dosing interval of 168 hours.
  • Apparent Clearance (CL/F) of PF-04856883: Stage 1 [ Time Frame: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1 ]
    It was calculated by dividing dose with AUC (0 - ∞) where AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). Outcome measure was planned to be analyzed in Stage 1 only.
  • Apparent Clearance (CL/F) of PF-04856883: Stage 2 [ Time Frame: predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22 ]
    It was calculated by dividing dose with AUC (0 - ∞) where AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). Outcome measure was planned to be analyzed in Stage 2 only. Data was not estimable if values were below the limit of quantification.
  • Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 1 [ Time Frame: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1 ]
  • Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 2 [ Time Frame: predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22 ]
  • Terminal Elimination Half- Life (t1/2) of PF-04856883: Stage 1 [ Time Frame: predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1 ]
  • Terminal Elimination Half-life (t1/2) of PF-04856883: Stage 2 [ Time Frame: predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22 ]
  • Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 [ Time Frame: Baseline, Day 3 and 8 ]
    Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC
  • Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 [ Time Frame: Baseline, Day 3, 15, 24, 29 and 50 ]
    Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
  • Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 [ Time Frame: Baseline, Day 3 and 8 ]
    Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
  • Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 [ Time Frame: Baseline, Day 3, 15, 24, 29 and 50 ]
    Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
  • Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1 [ Time Frame: Baseline, Day 3 and 8 ]
    Change from baseline in post-prandial area under the plasma C-peptide concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
  • Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2 [ Time Frame: Baseline, Day 3, 15, 24, 29 and 50 ]
    Change from baseline in post-prandial area under the plasma C-peptide concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.
  • Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1 [ Time Frame: Baseline, Day 2, 4, 6, 15, 22 and 29 ]
  • Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2 [ Time Frame: Baseline, Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43 ]
  • Change From Baseline in 24 Hours Glucose Normalized Area Under the Curve (NAUC) Profile at Day 30: Stage 2 [ Time Frame: Baseline, Day 30 ]
    A normalized area under the curve (NAUC) were computed by dividing the AUC by the amount of time between the last time point captured and the first time point captured.
  • Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29 and 50: Stage 2 [ Time Frame: Baseline, Day 29 and 50 ]
    HbA1c is a measure of the glycosylated hemoglobin. Change (measured as percent): HbA1c at observation minus HbA1c at baseline. Outcome measure was planned to analyzed only for Stage 2.
  • Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1 [ Time Frame: Baseline, Day 8, 15 and 29 ]
  • Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2 [ Time Frame: Baseline, Day 8, 15, 22, 29 and 50 ]
  • Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1 [ Time Frame: Baseline, Day 8, 15 and 29 ]
  • Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2 [ Time Frame: Baseline, Day 8, 15, 22, 29 and 50 ]
  • Number of Participants With Anti-Drug Antibodies (ADA): Stage 1 [ Time Frame: Day 1 and 29 ]
  • Number of Participant With Anti-Drug Antibodies (ADA): Stage 2 [ Time Frame: Day 1, 29 and 50 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2011)
  • Maximum observed plasma concentration (Cmax) of PF-04856883 (Stage 1) [ Time Frame: Days 1, 2, 3, 4, 6, 8, 15, 22, 29 ]
  • Maximum observed plasma concentration (Cmax) of PF-04856883 (Stage 2) [ Time Frame: Days 1, 2, 3, 4, 6, 8, 22, 23, 24, 25, 27, 29, 36, 43, 50 ]
  • Time to reach maximum observed plasma concentration (Tmax) of PF-04856883 (Stage 1) [ Time Frame: Days 1, 2, 3, 4, 6, 8, 15, 22, 29 ]
  • Time to reach maximum observed plasma concentration (Tmax) of PF-04856883 (Stage 2) [ Time Frame: Days 1, 2, 3, 4, 6, 8, 22, 23, 24, 25, 27, 29, 36, 43, 50 ]
  • Area under the concentration-time curve extrapolated to infinity (AUC0-inf) of PF-04856883 (Stage 1) [ Time Frame: Days 1, 2, 3, 4, 6, 8, 15, 22, 29 ]
  • Area under the concentration-time curve extrapolated to tau (AUC0-tau) of PF-04856883 (Stage 2) [ Time Frame: Days 1, 2, 3, 4, 6, 8, 22, 23, 24, 25, 27, 29, 36, 43, 50 ]
  • Clearance (CL/F) of PF-04856883 (Stage 1) [ Time Frame: Days 1, 2, 3, 4, 6, 8, 15, 22, 29 ]
  • Clearance (CL/F) of PF-04856883 (Stage 2) [ Time Frame: Days 1, 2, 3, 4, 6, 8, 22, 23, 24, 25, 27, 29, 36, 43, 50 ]
  • Volume of distribution (Vz/F) of PF-04856883 (Stage 1) [ Time Frame: Days 1, 2, 3, 4, 6, 8, 15, 22, 29 ]
  • Volume of distribution (Vz/F) of PF-04856883 (Stage 2) [ Time Frame: Days 1, 2, 3, 4, 6, 8, 22, 23, 24, 25, 27, 29, 36, 43, 50 ]
  • Terminal elimination half-life (t1/2) of PF-04856883 (Stage 1) [ Time Frame: Days 1, 2, 3, 4, 6, 8, 15, 22, 29 ]
  • Terminal elimination half-life (t1/2) of PF-04856883 (Stage 2) [ Time Frame: Days 1, 2, 3, 4, 6, 8, 22, 23, 24, 25, 27, 29, 36, 43, 50 ]
  • Change in postprandial glucose area under the concentration-time curve (AUC) after mixed meal tolerance test (Stage 1) [ Time Frame: Baseline, Day 3, Day 8 ]
  • Change in postprandial glucose area under the concentration-time curve (AUC) after mixed meal tolerance test (Stage 2) [ Time Frame: Baseline, Day 3, Day 15, Day 24, Day 29, Day 50 ]
  • Change in insulin area under the concentration-time curve (AUC) after mixed meal tolerance test (Stage 1) [ Time Frame: Baseline, Day 3, Day 8 ]
  • Change in insulin area under the concentration-time curve (AUC) after mixed meal tolerance test (Stage 2) [ Time Frame: Baseline, Day 3, Day 15, Day 24, Day 29, Day 50 ]
  • Change in C-peptide area under the concentration-time curve (AUC) after mixed meal tolerance test (Stage 1) [ Time Frame: Baseline, Day 3, Day 8 ]
  • Change in C-peptide area under the concentration-time curve (AUC) after mixed meal tolerance test (Stage 2) [ Time Frame: Baseline, Day 3, Day 15, Day 24, Day 29, Day 50 ]
  • Change in fasting plasma glucose (Stage 1) [ Time Frame: Baseline, Days 1, 2, 3, 4, 6, 8, 15, 22, 29 ]
  • Change in fasting plasma glucose (Stage 2) [ Time Frame: Baseline, Days 1, 2, 3, 4, 6, 8, 15, 22, 23, 24, 25, 27, 28, 29, 30, 36, 43, 50 ]
  • Change in 24 hour glucose profile (Stage 2) [ Time Frame: Baseline, Day 29 ]
  • Change in hemoglobin A1c (Stage 2) [ Time Frame: Baseline, Day 29, Day 50 ]
  • Change in fructosamine (Stage 1) [ Time Frame: Baseline, Day 8, Day 15, Day 29 ]
  • Change in fructosamine (Stage 2) [ Time Frame: Baseline, Day 8, Day 15, Day 22, Day 29, Day 50 ]
  • Change in 1,5-anhydroglucitol (Stage 1) [ Time Frame: Baseline, Day 8, Day 15, Day 29 ]
  • Change in 1,5-anhydroglucitol (Stage 2) [ Time Frame: Baseline, Day 8, Day 15, Day 22, Day 29, Day 50 ]
  • Number of participants with anti-PF-04856883 antibodies (Stage 1) [ Time Frame: Baseline up to Day 29 ]
  • Number of participants with anti-PF-04856883 antibodies (Stage 2) [ Time Frame: Baseline up to Day 50 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Single-Dose And Multiple-Dose Safety And Tolerability Study Of PF-04856883 In Type 2 Diabetic Adult Females
Official Title  ICMJE A Phase 1, Double-blind, Placebo-controlled, Randomized, Parallel Group Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Pf-04856883 In Adult Female Subjects With Type 2 Diabetes Mellitus
Brief Summary The primary objective of this study is to evaluate the safety and tolerability of PF-04856883 (CVX-096) in adult female subjects with Type 2 diabetes mellitus on high dose of metformin.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes Mellitus
  • Diabetes Mellitus, Type 2
  • Glucose Metabolism Disorders
  • Metabolic Diseases
  • Endocrine System Diseases
Intervention  ICMJE
  • Biological: Placebo
    Single subcutaneous injection of placebo
  • Biological: PF-04856883
    Single subcutaneous injection of PF-04856883
    Other Name: CVX-096
  • Biological: Placebo
    Multiple weekly subcutaneous injections of placebo for 3 weeks
    Other Name: CVX-096
  • Biological: PF-04856883
    Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
    Other Name: CVX-096
Study Arms  ICMJE
  • Placebo Comparator: Treatment Arm 1 (Stage 1A)
    Intervention: Biological: Placebo
  • Experimental: Treatment Arm 2 (Stage 1A)
    Intervention: Biological: PF-04856883
  • Experimental: Treatment Arm 3 (Stage 1A)
    Intervention: Biological: PF-04856883
  • Experimental: Treatment Arm 4 (Stage 1A)
    Intervention: Biological: PF-04856883
  • Placebo Comparator: Treatment Arm 5 (Stage 1B)
    Intervention: Biological: Placebo
  • Experimental: Treatment Arm 6 (Stage 1B)
    Intervention: Biological: PF-04856883
  • Experimental: Treatment Arm 7 (Stage 1B)
    Intervention: Biological: PF-04856883
  • Experimental: Treatment Arm 8 (Stage 1B)
    Intervention: Biological: PF-04856883
  • Placebo Comparator: Treatment Arm 9 (Stage 2)
    Intervention: Biological: Placebo
  • Experimental: Treatment Arm 10 (Stage 2)
    Intervention: Biological: PF-04856883
  • Experimental: Treatment Arm 11 (Stage 2)
    Intervention: Biological: PF-04856883
  • Experimental: Treatment Arm 12 (Stage 2)
    Intervention: Biological: PF-04856883
  • Experimental: Treatment Arm 13 (Stage 2)
    Intervention: Biological: PF-04856883
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 6, 2012)
84
Original Estimated Enrollment  ICMJE
 (submitted: February 21, 2011)
54
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • History of Type 2 diabetes and currently being treated with high dose metformin
  • BMI between 22.0 and 40.0 kg/m2
  • HbA1c between 7.0-10.0%
  • Fasting C-peptide >1.21 ng/mL

Exclusion Criteria:

  • History of clinically significant chronic conditions other than Type 2 diabetes not well controlled by either diet or medications
  • Treatment with anti-diabetic therapies other than metformin
  • History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody
  • Males or women of childbearing potential
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01301456
Other Study ID Numbers  ICMJE B1111002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP