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A Phase 2 Extension Study To Enroll Subjects Who Were Enrolled In B5301001 Study

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ClinicalTrials.gov Identifier: NCT02205476
Recruitment Status : Terminated (B5301001 study did not meet its predefined efficacy endpoints, the long term follow up study B5301012 was terminated in 1/6/2015. No safety concerns identified.)
First Posted : July 31, 2014
Results First Posted : January 28, 2016
Last Update Posted : January 28, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hypertrophic Scars Resulting From Prior Breast Scar Revision Surgery
Intervention Drug: PF-06473871
Enrollment 10
Recruitment Details Participants who received the treatment in previous study B5301001 (NCT01730339), were enrolled in this study.
Pre-assignment Details Participants who completed part A of the study had the option to obtain scar revision surgery with PF-06473871 in part B of the study. No participant entered into part B due to premature termination of the study.
Arm/Group Title Group 1: PF--06473871/Placebo (4* 5 mg/cm) Group 2: PF--06473871/Placebo (3* 5 mg/cm)
Hide Arm/Group Description Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 at a dose of 5 milligram per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery. Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
Period Title: Overall Study
Started 7 3
Completed 0 0
Not Completed 7 3
Reason Not Completed
Study termination by Sponsor             7             3
Arm/Group Title Group 1: PF--06473871/Placebo (4* 5 mg/cm) Group 2: PF--06473871/Placebo (3* 5 mg/cm) Total
Hide Arm/Group Description Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 at a dose of 5 milligram per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery. Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery. Total of all reporting groups
Overall Number of Baseline Participants 7 3 10
Hide Baseline Analysis Population Description
Enrolled analysis set included all participants who signed an informed consent and for whom data were collected for Part A of this trial.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 3 participants 10 participants
40.7  (6.80) 39.0  (15.13) 40.2  (9.08)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 3 participants 10 participants
Female
7
 100.0%
3
 100.0%
10
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) at Part A Visit
Hide Description Physician scar assessment was performed using 10-point POSAS scale. Physician rated each of the items (vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion) for a scar on a score of 1 (normal skin) to 10 (worst scar imaginable).
Time Frame 52 weeks after initial scar revision surgery in study B5301001
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled analysis set included all participants who signed an informed consent and for whom data were collected for Part A of this trial.
Arm/Group Title Group 1: PF--06473871: 4* 5 mg/cm Group 1: Placebo: 4* 5 mg/cm Group 2: PF¬06473871: 3* 5 mg/cm Group 2: Placebo: 3* 5 mg/cm
Hide Arm/Group Description:
Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) and were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast and 3 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
Overall Number of Participants Analyzed 7 7 3 3
Mean (Standard Deviation)
Unit of Measure: units on scale
Vascularity 2.71  (1.496) 2.71  (1.113) 1.33  (0.577) 2.00  (1.000)
Pigmentation 3.79  (2.307) 5.00  (2.517) 2.00  (1.000) 3.00  (2.000)
Thickness 3.86  (2.478) 4.64  (2.286) 2.00  (1.000) 3.00  (2.000)
Relief 4.14  (2.795) 4.36  (2.358) 2.00  (1.000) 3.67  (3.055)
Pliability 3.50  (2.693) 3.93  (2.805) 1.67  (0.577) 3.67  (3.055)
Surface Area 4.86  (2.193) 4.57  (2.573) 2.33  (0.577) 3.33  (2.517)
Overall opinion 4.29  (2.628) 4.64  (2.561) 2.00  (1.000) 3.00  (2.000)
2.Primary Outcome
Title Part B: Number of Participants With Clinically Significant Vital Sign Abnormalities
Hide Description Vital signs included pulse rate and systolic blood pressure and diastolic blood pressure.
Time Frame Part B: Baseline up to Week 15
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure was not analyzed because part B was not initiated due to early termination of the study during Part A.
Arm/Group Title Group 1: PF--06473871/Placebo: 4* 5 mg/cm Group 2: PF--06473871/Placebo: 3* 5 mg/cm
Hide Arm/Group Description:
Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery and were planned to receive scar revision surgery in part B of the study.
Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery and were planned to receive scar revision surgery in part B of the study.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Primary Outcome
Title Part B: Number of Participants With Clinical Laboratory Abnormalities
Hide Description Clinical laboratory tests included clinical chemistry (sodium, potassium, chloride, bicarbonate, glucose, blood urea nitrogen (BUN), creatinine, albumin, calcium, total, direct and indirect bilirubin, gamma-glutamyltransferase (GGT), alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactic dehydrogenase (LDH), alkaline phosphatase, creatine phosphokinase (CPK), uric acid, amylase and lipase) and hematology (hemoglobin, hematocrit, red blood cell count (RBC), white blood cell count (WBC) with differential, and platelet count) tests to be performed.
Time Frame Part B: Baseline up to Week 15
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure was not analyzed because part B was not initiated due to early termination of the study during Part A.
Arm/Group Title Group 1: PF--06473871/Placebo: 4* 5 mg/cm Group 2: PF--06473871/Placebo: 3* 5 mg/cm
Hide Arm/Group Description:
Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery and were planned to receive scar revision surgery in part B of the study.
Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery and were planned to receive scar revision surgery in part B of the study.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Primary Outcome
Title Part B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)
Hide Description An Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A 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 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Data for this outcome measure was not analyzed because part B was not initiated due to early termination of the study during Part A.
Time Frame Part B: Baseline up to Week 15
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure was not analyzed because part B was not initiated due to early termination of the study during Part A.
Arm/Group Title Group 1: PF--06473871/Placebo: 4* 5 mg/cm Group 2: PF--06473871/Placebo: 3* 5 mg/cm
Hide Arm/Group Description:
Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery and were planned to receive scar revision surgery in part B of the study.
Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery and were planned to receive scar revision surgery in part B of the study.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS) at Part A Visit
Hide Description Patient global assessment was performed using the overall opinion question of the POSAS scale. Participants were asked to rate the severity of their scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (very different from normal skin).
Time Frame 52 weeks after initial scar revision surgery in study B5301001
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled analysis set included all participants who signed an informed consent and for whom data were collected for Part A of this trial.
Arm/Group Title Group 1: PF-06473871: 4* 5 mg/cm Group 1: Placebo: 4* 5 mg/cm Group 2: PF-06473871: 3* 5 mg/cm Group 2: Placebo: 3* 5 mg/cm
Hide Arm/Group Description:
Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) and were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast and 3 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
Overall Number of Participants Analyzed 7 7 3 3
Mean (Standard Deviation)
Unit of Measure: units on scale
7.07  (2.281) 6.57  (3.552) 3.00  (1.732) 4.00  (2.646)
6.Secondary Outcome
Title Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptom and Appearance Domain Score at Part A Visit
Hide Description PR-SEQ questionnaire consisted of 30 different attributes of scars that included following four dimensions: appearance (5 attributes), symptoms (3 attributes), bothersomeness (8 attributes), and impacts on the quality of life (physical and emotional wellbeing [14 attributes]). Each question had 5 possible responses: not at all (0), slightly (1), moderately (2), very (3), and extremely (4). Subjects completed an abbreviated version which included only the Symptoms and Appearance dimensions to evaluate treatment outcomes. Each of the item scores were transformed into a 0 to 100 scale. Each dimension score was calculated from averaging the transformed scores (0 to 100 scaled) for specified items. Each domain score ranged from 0 to 100, with higher scores indicating higher severity.
Time Frame 52 weeks after initial scar revision surgery in study B5301001
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled analysis set included all participants who signed an informed consent and for whom data were collected for Part A of this trial.
Arm/Group Title Group 1: PF-06473871: 4* 5 mg/cm Group 1: Placebo: 4* 5 mg/cm Group 2: PF¬06473871: 3* 5 mg/cm Group 2: Placebo: 3* 5 mg/cm
Hide Arm/Group Description:
Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) and were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast and 3 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
Overall Number of Participants Analyzed 7 7 3 3
Mean (Standard Deviation)
Unit of Measure: units on scale
Appearance 46.79  (28.965) 49.29  (30.745) 33.33  (12.583) 48.33  (41.633)
Symptoms 23.21  (24.516) 9.52  (16.962) 0.00  (0.000) 0.00  (0.000)
7.Secondary Outcome
Title Physician and Participant Photoguide Scar Assessment Scale Score at Part A Visit
Hide Description Physician and participants rated severity of each scar using a photonumeric guide on a scale ranging from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe).
Time Frame 52 weeks after initial scar revision surgery in study B5301001
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled analysis set included all participants who signed an informed consent and for whom data were collected for Part A of this trial.
Arm/Group Title Group 1: PF-06473871: 4* 5 mg/cm Group 1: Placebo: 4* 5 mg/cm Group 2: PF¬06473871: 3* 5 mg/cm Group 2: Placebo: 3* 5 mg/cm
Hide Arm/Group Description:
Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) and were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast and 3 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
Overall Number of Participants Analyzed 7 7 3 3
Mean (Standard Deviation)
Unit of Measure: units on scale
Physician assessment 2.64  (1.600) 3.00  (1.414) 1.33  (0.577) 2.33  (1.528)
Participant assessment 2.79  (1.577) 3.14  (1.773) 1.67  (0.577) 2.67  (2.082)
8.Other Pre-specified Outcome
Title Volumetric & Colorimetric Scar Assessment (3D Imaging) at Part A Visit
Hide Description Three-dimension digital photography was planned to be taken of the participants scars for determination of scar volume, height, and color performed in a subset of selected investigational centers equipped with specialized 3D photographic equipment.
Time Frame 52 weeks after initial scar revision surgery in study B5301001
Hide Outcome Measure Data
Hide Analysis Population Description
The volumetric and colorimetric scar assessments were collected under this protocol but were not analyzed.
Arm/Group Title Group 1: PF--06473871: 4* 5 mg/cm Group 1: Placebo: 4* 5 mg/cm Group 2: PF¬06473871: 3* 5 mg/cm Group 2: Placebo: 3* 5 mg/cm
Hide Arm/Group Description:
Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) and were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast and 3 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events were planned to be assessed in part B of the study. Part B of study was not initiated due to premature termination during part A of the study.
 
Arm/Group Title Group 1: PF--06473871/Placebo (4* 5 mg/cm) Group 2: PF--06473871/Placebo (3* 5 mg/cm)
Hide Arm/Group Description Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 at a dose of 5 milligram per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery. Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
All-Cause Mortality
Group 1: PF--06473871/Placebo (4* 5 mg/cm) Group 2: PF--06473871/Placebo (3* 5 mg/cm)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Group 1: PF--06473871/Placebo (4* 5 mg/cm) Group 2: PF--06473871/Placebo (3* 5 mg/cm)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group 1: PF--06473871/Placebo (4* 5 mg/cm) Group 2: PF--06473871/Placebo (3* 5 mg/cm)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
The study was prematurely terminated at the discretion of sponsor as study B5301001 did not meet its pre-defined efficacy endpoints for the dosing regimens evaluated.
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: NCT02205476    
Other Study ID Numbers: B5301012
2014-002703-17 ( EudraCT Number )
First Submitted: July 29, 2014
First Posted: July 31, 2014
Results First Submitted: December 21, 2015
Results First Posted: January 28, 2016
Last Update Posted: January 28, 2016