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A 12 Day Study To Evaluate A Topical Drug To Treat Plaque Psoriasis

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: NCT02193815
Recruitment Status : Completed
First Posted : July 18, 2014
Results First Posted : June 9, 2016
Last Update Posted : June 9, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Psoriasis Vulgaris
Interventions Drug: PF06263276
Other: Vehicle
Drug: 2%Tofacitinib Ointment
Drug: Daivonex
Drug: Daivonex Ointment
Enrollment 15
Recruitment Details  
Pre-assignment Details This trial enrolled participants with chronic plaque type psoriasis and with a treatment area sufficient for 6 treatment fields on 1 to 3 comparable plaques defined as having treatment fields with psoriatic skin thickness/Echo-Poor Band (EPB) of at least 200 micrometers.
Arm/Group Title All Participants
Hide Arm/Group Description Participants received the following treatments topically to 6 selected treatment fields: 4% PF-06263276 and its corresponding vehicle, 2% tofacitinib and its corresponding vehicle, calcipotriol (Daivonex) solution, and Daivonex ointment. The fields were occluded and participants returned daily to the center for re-application during the 11-day treatment period.
Period Title: Overall Study
Started 15
Completed 15
Not Completed 0
Arm/Group Title All Participants
Hide Arm/Group Description Participants received the following treatments topically to 6 selected treatment fields: 4% PF-06263276 and its corresponding vehicle, 2% tofacitinib and its corresponding vehicle, calcipotriol (Daivonex) solution, and Daivonex ointment. The fields were occluded and participants returned daily to the center for re-application during the 11-day treatment period.
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
The safety population included all enrolled participants who received at least 1 dose of investigational product.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
50.4  (8.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
2
  13.3%
Male
13
  86.7%
1.Primary Outcome
Title Change From Baseline in Psoriatic Skin Thickness/Echo-Poor Band (EPB) for PF-06263276 4% Solution in Comparison to Corresponding Vehicle at Day 12
Hide Description Psoriatic skin thickness was measured using a 20 megahertz (MHz) high frequency sonograph. Serial A-scans were composed and presented on a monitor as a section of the skin.
Time Frame Day 1 (Baseline), Day 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.
Arm/Group Title PF-06263276 4% Solution PF-06263276 Vehicle
Hide Arm/Group Description:
All participants who received PF-06263276 4% solution topically once daily for 11 days.
All participants who received PF-06263276 vehicle (active ingredient- free) topically once daily for 11 days.
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: micrometers
Baseline 358.9  (132.84) 353.1  (121.03)
Change at Day 12 17.7  (91.10) 32.9  (96.72)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-06263276 4% Solution, PF-06263276 Vehicle
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3465
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean Ratio
Estimated Value 93.20
Confidence Interval (2-Sided) 95%
80.43 to 107.99
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.075
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Psoriatic Skin Thickness/EPB for PF-06263276 4% Solution in Comparison to Daivonex Solution at Day 12
Hide Description [Not Specified]
Time Frame Day 1 (Baseline), Day 12
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.
Arm/Group Title PF-06263276 4% Solution Daivonex Solution
Hide Arm/Group Description:
All participants who received PF-06263276 4% solution topically once daily for 11 days.
All participants who received calcipotriol solution (50 micrograms per milliliter [mcg/mL]) topically once daily for 11 days.
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: micrometers
17.7  (91.10) -135.5  (114.27)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-06263276 4% Solution, Daivonex Solution
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean
Estimated Value 165.88
Confidence Interval (2-Sided) 95%
143.12 to 192.25
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.075
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Psoriatic Skin Thickness/EPB for Tofacitinib 2% Ointment in Comparison to Corresponding Vehicle at Day 12
Hide Description [Not Specified]
Time Frame Day 1 (Baseline), Day 12
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.
Arm/Group Title Tofacitinib 2% Ointment Tofacitinib Vehicle
Hide Arm/Group Description:
All participants who received tofacitinib 2% ointment topically once daily for 11 days.
All participants who received tofacitinib vehicle (active ingredient-free) topically once daily for 11 days.
Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: micrometers
Baseline 364.1  (135.82) 357.3  (135.60)
Change at Day 12 -117.8  (115.15) 0.1  (95.04)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tofacitinib 2% Ointment, Tofacitinib Vehicle
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean
Estimated Value 65.42
Confidence Interval (2-Sided) 95%
56.46 to 75.81
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.075
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Psoriatic Skin Thickness/EPB at Day 8
Hide Description [Not Specified]
Time Frame Day 1 (Baseline), Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.
Arm/Group Title PF-06263276 4% Solution PF-06263276 Vehicle Tofacitinib 2% Ointment Tofacitinib Vehicle Daivonex Solution Daivonex Ointment
Hide Arm/Group Description:
All participants who received PF-06263276 4% solution topically once daily for 11 days.
All participants who received PF-06263276 vehicle (active ingredient-free) topically once daily for 11 days.
All participants who received tofacitinib 2% ointment topically once daily for 11 days.
All participants who received tofacitinib vehicle (active ingredient-free) topically once daily for 11 days.
All participants who received calcipotriol solution (50 micrograms per milliliter [mcg/mL]) topically once daily for 11 days.
All participants who received calcipotriol ointment (50 micrograms per gram [mcg/g]) topically once daily for 11 days.
Overall Number of Participants Analyzed 15 15 15 15 15 15
Mean (Standard Deviation)
Unit of Measure: micrometers
Baseline 358.9  (132.84) 353.1  (121.03) 364.1  (135.82) 357.3  (135.60) 376.1  (148.44) 364.1  (124.35)
Change at Day 8 18.0  (86.37) 38.5  (65.45) -90.5  (84.11) 15.1  (104.55) -98.8  (127.18) -104.7  (65.83)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-06263276 4% Solution, PF-06263276 Vehicle
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3349
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean
Estimated Value 93.04
Confidence Interval (2-Sided) 95%
80.30 to 107.81
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.075
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-06263276 4% Solution, Daivonex Solution
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean
Estimated Value 149.56
Confidence Interval (2-Sided) 95%
129.04 to 173.34
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.075
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 2% Ointment, Daivonex Ointment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3991
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean
Estimated Value 106.51
Confidence Interval (2-Sided) 95%
91.92 to 123.41
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.075
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib 2% Ointment, Tofacitinib Vehicle
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean
Estimated Value 71.94
Confidence Interval (2-Sided) 95%
62.08 to 83.36
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.075
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Area Under the Curve (AUC) of Psoriatic Skin Thickness/EPB
Hide Description The AUC of psoriatic skin thickness/EPB from Day 1 to Day 12 was determined using the linear trapezoidal rule. The mean raw values are reported.
Time Frame Day 1 (baseline) up to Day 12
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.
Arm/Group Title PF-06263276 4% Solution PF-06263276 Vehicle Tofacitinib 2% Ointment Tofacitinib Vehicle Daivonex Solution Daivonex Ointment
Hide Arm/Group Description:
All participants who received PF-06263276 4% solution topically once daily for 11 days.
All participants who received PF-06263276 vehicle (active ingredient-free) topically once daily for 11 days.
All participants who received tofacitinib 2% ointment topically once daily for 11 days.
All participants who received tofacitinib vehicle (active ingredient-free) topically once daily for 11 days.
All participants who received calcipotriol solution (50 micrograms per milliliter [mcg/mL]) topically once daily for 11 days.
All participants who received calcipotriol ointment (50 micrograms per gram [mcg/g]) topically once daily for 11 days.
Overall Number of Participants Analyzed 15 15 15 15 15 15
Mean (Standard Deviation)
Unit of Measure: micrometers*day
4082.60  (1726.167) 4161.40  (1436.733) 3271.93  (1210.138) 4013.07  (1465.339) 3322.40  (1663.668) 3165.47  (1113.937)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-06263276 4% Solution, PF-06263276 Vehicle
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7529
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean
Estimated Value 96.04
Confidence Interval (2-Sided) 95%
74.00 to 124.64
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.127
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-06263276 4% Solution, Daivonex Solution
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1318
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean
Estimated Value 125.62
Confidence Interval (2-Sided) 95%
92.96 to 169.75
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.147
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tofacitinib 2% Ointment, Daivonex Ointment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8009
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean
Estimated Value 103.35
Confidence Interval (2-Sided) 95%
79.30 to 134.68
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.129
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tofacitinib 2% Ointment, Tofacitinib Vehicle
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1012
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean
Estimated Value 81.09
Confidence Interval (2-Sided) 95%
62.94 to 104.47
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.124
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Global Clinical Assessment at Day 1, 8 and 12
Hide Description Global Clinical Assessment of the test fields was performed by visual examination using a 5-point score (-1=worsened; 0=unchanged [no effect]; 1=slight improvement; 2=clear improvement but not completely healed; 3=completely healed). Clinically apparent differences in erythema and infiltration will contribute to this global assessment. At baseline (Day 1), the score was documented as "0" (unchanged).
Time Frame Day 1, Day 8, Day 12
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.
Arm/Group Title PF-06263276 4% Solution PF-06263276 Vehicle Tofacitinib 2% Ointment Tofacitinib Vehicle Daivonex Solution Daivonex Ointment
Hide Arm/Group Description:
All participants who received PF-06263276 4% solution topically once daily for 11 days.
All participants who received PF-06263276 vehicle (active ingredient-free) topically once daily for 11 days.
All participants who received tofacitinib 2% ointment topically once daily for 11 days.
All participants who received tofacitinib vehicle (active ingredient-free) topically once daily for 11 days.
All participants who received calcipotriol solution (50 micrograms per milliliter [mcg/mL]) topically once daily for 11 days.
All participants who received calcipotriol ointment (50 micrograms per gram [mcg/g]) topically once daily for 11 days.
Overall Number of Participants Analyzed 15 15 15 15 15 15
Measure Type: Number
Unit of Measure: participants
Day 1: Score -1 0 0 0 0 0 0
Day 1: Score 0 15 15 15 15 15 15
Day 1: Score 1 0 0 0 0 0 0
Day 1: Score 2 0 0 0 0 0 0
Day 1: Score 3 0 0 0 0 0 0
Day 8: Score -1 0 0 0 0 1 0
Day 8: Score 0 13 15 4 14 1 1
Day 8: Score 1 2 0 8 0 9 6
Day 8: Score 2 0 0 3 1 4 8
Day 8: Score 3 0 0 0 0 0 0
Day 12: Score -1 0 0 0 0 1 1
Day 12: Score 0 13 15 4 11 1 2
Day 12: Score 1 2 0 8 3 6 4
Day 12: Score 2 0 0 3 1 7 8
Day 12: Score 3 0 0 0 0 0 0
7.Other Pre-specified Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Specified Skin AEs
Hide Description An AE was any untoward medical occurrence in a participant who received study drug. 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 that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs. The number of participants with specified skin AEs was reported.
Time Frame Baseline up to 28 days after last study drug administration (Day 21)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all enrolled participants who received at least 1 dose of investigational product.
Arm/Group Title PF-06263276 4% Solution PF-06263276 Vehicle Tofacitinib 2% Ointment Tofacitinib Vehicle Daivonex Solution Daivonex Ointment
Hide Arm/Group Description:
All participants who received PF-06263276 4% solution topically once daily for 11 days.
All participants who received PF-06263276 vehicle (active ingredient-free) topically once daily for 11 days.
All participants who received tofacitinib 2% ointment topically once daily for 11 days.
All participants who received tofacitinib vehicle (active ingredient-free) topically once daily for 11 days.
All participants who received calcipotriol solution (50 micrograms per milliliter [mcg/mL]) topically once daily for 11 days.
All participants who received calcipotriol ointment (50 micrograms per gram [mcg/g]) topically once daily for 11 days.
Overall Number of Participants Analyzed 15 15 15 15 15 15
Measure Type: Number
Unit of Measure: participants
Specified Skin AEs 0 0 0 0 0 2
Specified Skin SAEs 0 0 0 0 0 0
8.Other Pre-specified Outcome
Title Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern
Hide Description The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, RBC morphology, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (e.g., urine human chorionic gonadotropin [hCG] for females of childbearing potential).
Time Frame Baseline up to Day 12
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all enrolled participants who received at least 1 dose of investigational product.
Arm/Group Title All Participants
Hide Arm/Group Description:
Participants received the following treatments topically to 6 selected treatment fields: 4% PF-06263276 and its corresponding vehicle, 2% tofacitinib and its corresponding vehicle, calcipotriol (Daivonex) solution, and Daivonex ointment. The fields were occluded and participants returned daily to the center for re-application during the 11-day treatment period.
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: participants
6
9.Other Pre-specified Outcome
Title Number of Participants With Potentially Clinically Significant Vital Signs Findings
Hide Description Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate <40 or >120 beats per minute (bpm), standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) >=30 millimeters of mercury (mmHg) change from baseline in same posture or SBP <90 mmHg, diastolic blood pressure (DBP) >=20 mmHg change from baseline in same posture or DBP <50 mmHg.
Time Frame Baseline up to Day 12
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all enrolled participants who received at least 1 dose of investigational product.
Arm/Group Title All Participants
Hide Arm/Group Description:
Participants received the following treatments topically to 6 selected treatment fields: 4% PF-06263276 and its corresponding vehicle, 2% tofacitinib and its corresponding vehicle, calcipotriol (Daivonex) solution, and Daivonex ointment. The fields were occluded and participants returned daily to the center for re-application during the 11-day treatment period.
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: participants
SBP <90 mmHg 0
DBP <50 mmHg 0
Pulse Rate <40 or >120 bpm 0
Maximum Increase from Baseline in SBP >=30 mmHg 0
Maximum Increase from Baseline in DBP >=20 mmHg 0
Time Frame Baseline up to 28 days after last study drug administration (Day 21)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Participants
Hide Arm/Group Description Participants received the following treatments topically to 6 selected treatment fields: 4% PF-06263276 and its corresponding vehicle, 2% tofacitinib and its corresponding vehicle, calcipotriol (Daivonex) solution, and Daivonex ointment. The fields were occluded and participants returned daily to the center for re-application during the 11-day treatment period.
All-Cause Mortality
All Participants
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
All Participants
Affected / at Risk (%)
Total   0/15 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Participants
Affected / at Risk (%)
Total   3/15 (20.00%) 
Gastrointestinal disorders   
Nausea * 1  1/15 (6.67%) 
General disorders   
Facial pain * 1  1/15 (6.67%) 
Nervous system disorders   
Dizziness * 1  1/15 (6.67%) 
Skin and subcutaneous tissue disorders   
Blister * 1  2/15 (13.33%) 
Dermatitis * 1  1/15 (6.67%) 
Erythema * 1  1/15 (6.67%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 17.1
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02193815    
Other Study ID Numbers: B5391003
2014-000068-16 ( EudraCT Number )
First Submitted: July 16, 2014
First Posted: July 18, 2014
Results First Submitted: March 4, 2016
Results First Posted: June 9, 2016
Last Update Posted: June 9, 2016