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Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Study Of PF-04447943, Co-Administered With And Without Hydroxyurea, In Subjects With Stable Sickle Cell Disease

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: NCT02114203
Recruitment Status : Completed
First Posted : April 15, 2014
Results First Posted : December 14, 2017
Last Update Posted : December 14, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Basic Science
Condition Phase 1 Sickle Cell
Interventions Drug: PDE9i
Drug: placebo for PDE9i
Enrollment 30
Recruitment Details  
Pre-assignment Details Overall, a total of 30 potential participants were randomized to the study, and 29 of them were assigned to and received study treatment, 1 participant in the PF-04447943 25 mg twice daily (BID) treatment group withdrew from the study after randomization but prior to study treatment.
Arm/Group Title PF-04447943 5 mg BID PF-04447943 25 mg BID Placebo
Hide Arm/Group Description PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days. PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days. Placebo matched to PF-04447943 tablet was administered orally twice daily (BID) for up to 29 days.
Period Title: Overall Study
Started 7 16 7
Completed 7 14 7
Not Completed 0 2 0
Reason Not Completed
Adverse Event             0             1             0
Withdrawal by Subject             0             1             0
Arm/Group Title PF-04447943 5 mg BID PF-04447943 25 mg BID Placebo Total
Hide Arm/Group Description PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days. PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days. Placebo matched to PF-04447943 tablet was administered orally twice daily (BID) for up to 29 days. Total of all reporting groups
Overall Number of Baseline Participants 7 16 7 30
Hide Baseline Analysis Population Description
Baseline analysis population included all participants who were randomized.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 16 participants 7 participants 30 participants
37.9  (10.6) 36.3  (11.0) 39.4  (14.0) 37.4  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 16 participants 7 participants 30 participants
Female
3
  42.9%
10
  62.5%
5
  71.4%
18
  60.0%
Male
4
  57.1%
6
  37.5%
2
  28.6%
12
  40.0%
1.Primary Outcome
Title Number of Participants With Potentially Clinically Important (PCI) Change From Baseline in Vital Signs
Hide Description Number of participants with changes from baseline in vital signs meeting the following criteria is presented: (1) maximum increase from baseline in supine systolic blood pressure (SBP) >=30 millimeters of mercury (mmHg); (2) maximum increase from baseline in supine diastolic blood pressure (DBP) >=20 mmHg; (3) maximum decrease from baseline in supine SBP >=30 mmHg; and (4) maximum decrease from baseline in supine DBP >=20 mmHg.
Time Frame Baseline up to 30 days post last dose on Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population was defined as all participants who received at least 1 dose of study medication.
Arm/Group Title PF-04447943 5 mg BID PF-04447943 25 mg BID Placebo
Hide Arm/Group Description:
PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days.
PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days.
Placebo matched to PF-04447943 tablet was administered orally twice daily (BID) for up to 29 days.
Overall Number of Participants Analyzed 7 15 7
Measure Type: Number
Unit of Measure: participants
Maximum increase in supine SBP >=30 mmHg 0 0 0
Maximum increase in supine DBP >=20 mmHg 2 0 1
Maximum decrease in supine SBP >=30 mmHg 0 1 0
Maximum decrease in supine DBP >=20 mmHg 2 0 1
2.Primary Outcome
Title Number of Participants With Potentially Clinically Important (PCI) Change From Baseline in Neurologic Function
Hide Description Clinical assessment of neurologic functions included cranial nerve function, coordination, deep tendon reflexes, muscle strength, and reflexes (left and right ankles). Clinical importance of neurologic function changes was determined by the investigator.
Time Frame Baseline up to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population was defined as all participants who received at least 1 dose of study medication.
Arm/Group Title PF-04447943 5 mg BID PF-04447943 25 mg BID Placebo
Hide Arm/Group Description:
PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days.
PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days.
Placebo matched to PF-04447943 tablet was administered orally twice daily (BID) for up to 29 days.
Overall Number of Participants Analyzed 7 15 7
Measure Type: Number
Unit of Measure: participants
0 0 0
3.Primary Outcome
Title Number of Participants With Potentially Clinically Important (PCI) Change in Physical Examination Findings
Hide Description Physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. Clinical importance of physical examination changes was determined by the investigator.
Time Frame Baseline up to 30 days post last dose on Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population was defined as all participants who received at least 1 dose of study medication.
Arm/Group Title PF-04447943 5 mg BID PF-04447943 25 mg BID Placebo
Hide Arm/Group Description:
PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days.
PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days.
Placebo matched to PF-04447943 tablet was administered orally twice daily (BID) for up to 29 days.
Overall Number of Participants Analyzed 7 15 7
Measure Type: Number
Unit of Measure: participants
0 0 0
4.Primary Outcome
Title Number of Participants With Clinically Significant Treatment-Emergent Electrocardiogram (ECG) Findings
Hide Description Maximum absolute values and increases from baseline were summarized for PR interval (time from the beginning of P wave to the start of QRS complex, corresponding to the end of atrial depolarization and onset of ventricular depolarization), QRS complex (time from Q wave to the end of S wave, corresponding to ventricle depolarization), and QTcF interval (time from the beginning of Q wave to the end of T wave corresponding to electrical systole corrected for heart rate using Fridericia's formula). Number of participants with ECG findings meeting the following criteria is presented: (1) PR interval >=300 msec; (2) QRS complex >=200 msec; (3) QTcF interval: 450 to <480 msec; (4) QTcF interval: 480 to <500 msec; (5) QTcF interval >=500 msec; (6) PR interval percent increase from baseline >=25/50 percent; (7) QRS complex percent increase from baseline >=25/50 percent; (8) QTcF interval increase from baseline: 30 to <60 msec; (9) QTcF interval increase from baseline >=60 msec.
Time Frame Baseline up to 30 days post last dose on Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population was defined as all participants who received at least 1 dose of study medication.
Arm/Group Title PF-04447943 5 mg BID PF-04447943 25 mg BID Placebo
Hide Arm/Group Description:
PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days.
PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days.
Placebo matched to PF-04447943 tablet was administered orally twice daily (BID) for up to 29 days.
Overall Number of Participants Analyzed 7 15 7
Measure Type: Number
Unit of Measure: participants
Maximum PR interval >=300 msec 0 0 0
Maximum QRS complex >=200 msec 0 0 0
Maximum QTcF interval: 450 to <480 msec 0 3 2
Maximum QTcF interval: 480 to <500 msec 0 0 1
Maximum QTcF interval: >=500 msec 0 0 0
PR interval increase >=25/50 percent 0 0 0
QRS complex increase >=25/50 percent 0 0 0
QTcF interval increase: 30 to <60 msec 0 1 0
QTcF interval increase >=60 msec 0 0 0
5.Primary Outcome
Title Number of Participants With Potentially Clinically Important (PCI) Change From Baseline in Symptoms of Sickle Cell Disease
Hide Description The following symptoms were assessed: anemia; fatigue; chronic pain; acute pain; infections; fever; swelling hands; swelling feet; abdominal swelling; pale skin; pale nail beds; yellow tint to skin; whites of eyes turned yellow; stroke. Number of participants with changes from baseline deemed potentially clinically important by the investigator is presented.
Time Frame Baseline up to 30 days post last dose on Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population was defined as all participants who received at least 1 dose of study medication.
Arm/Group Title PF-04447943 5 mg BID PF-04447943 25 mg BID Placebo
Hide Arm/Group Description:
PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days.
PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days.
Placebo matched to PF-04447943 tablet was administered orally twice daily (BID) for up to 29 days.
Overall Number of Participants Analyzed 7 15 7
Measure Type: Number
Unit of Measure: participants
0 0 0
6.Primary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Hide Description An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of its causal relationship with study treatment. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; was life-threatening (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study drug and up to follow-up visit (30 days post last dose on Day 29) that were absent before treatment or that worsened after treatment. AEs included both serious and non-serious AEs.
Time Frame Day 1 to 30 days post last dose on Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population was defined as all participants who received at least 1 dose of study medication.
Arm/Group Title PF-04447943 5 mg BID PF-04447943 25 mg BID Placebo
Hide Arm/Group Description:
PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days.
PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days.
Placebo matched to PF-04447943 tablet was administered orally twice daily (BID) for up to 29 days.
Overall Number of Participants Analyzed 7 15 7
Measure Type: Number
Unit of Measure: participants
AEs 7 13 7
SAEs 2 1 0
Withdrawal due to TEAEs 0 1 0
7.Primary Outcome
Title Number of Participants With Laboratory Test Abnormalities
Hide Description The laboratory test included: hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, absolute total neutrophils, eosinophils, monocytes, basophils, and lymphocytes), chemistry (blood urea nitrogen/urea, serum creatinine, fasting glucose, calcium, sodium, potassium, chloride, total carbon dioxide, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein, and high sensitivity C-reactive protein), urinalysis (pH, qualitative glucose, qualitative protein, qualitative blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, and microscopy), and other tests (follicle stimulating hormone and serum human chorionic gonadotropin, urine drug screening). Abnormality was determined by the investigator.
Time Frame Baseline up to 30 days post last dose on Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population was defined as all participants who received at least 1 dose of study medication.
Arm/Group Title PF-04447943 5 mg BID PF-04447943 25 mg BID Placebo
Hide Arm/Group Description:
PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days.
PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days.
Placebo matched to PF-04447943 tablet was administered orally twice daily (BID) for up to 29 days.
Overall Number of Participants Analyzed 7 15 7
Measure Type: Number
Unit of Measure: participants
7 15 7
8.Secondary Outcome
Title Area Under the Curve From Time Zero to 12 Hours Post Dose (AUC(0-12h)) of PF-04447943
Hide Description AUC(0-12h) referred to area under the plasma concentration-time curve from 0 to 12 hours post dose.
Time Frame Prior to 0 hour, and 0.5, 1, 2, 4, 8, and 12 hours post dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) was used for all PK analyses, and it included all participants randomized to treatment who had taken at least 1 dose of study medication. Data for this outcome measure were not planned to be analyzed for the placebo arm.
Arm/Group Title PF-04447943 5 mg BID PF-04447943 25 mg BID
Hide Arm/Group Description:
PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days.
PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days.
Overall Number of Participants Analyzed 7 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram*hour/milliliter
242.0
(35%)
1170
(29%)
9.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of PF-04447943
Hide Description [Not Specified]
Time Frame Prior to 0 hour, and 0.5, 1, 2, 4, 8, and 12 hours post dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) was used for all PK analyses, and it included all participants randomized to treatment who had taken at least 1 dose of study medication. Data for this outcome measure were not planned to be analyzed for the placebo arm.
Arm/Group Title PF-04447943 5 mg BID PF-04447943 25 mg BID
Hide Arm/Group Description:
PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days.
PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days.
Overall Number of Participants Analyzed 7 15
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
45.83
(39%)
248.2
(31%)
10.Secondary Outcome
Title Time for Maximum Observed Plasma Concentration (Tmax) of PF-04447943
Hide Description [Not Specified]
Time Frame Prior to 0 hour, and 0.5, 1, 2, 4, 8, and 12 hours post dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) was used for all PK analyses, and it included all participants randomized to treatment who had taken at least 1 dose of study medication. Data for this outcome measure were not planned to be analyzed for the placebo arm.
Arm/Group Title PF-04447943 5 mg BID PF-04447943 25 mg BID
Hide Arm/Group Description:
PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days.
PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days.
Overall Number of Participants Analyzed 7 15
Median (Full Range)
Unit of Measure: hours
1.92
(1.00 to 4.00)
1.00
(0.500 to 4.05)
Time Frame Day 1 to follow-up visit (30 days post last dose on Day 29)
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
 
Arm/Group Title PF-04447943 5 mg BID PF-04447943 25 mg BID Placebo
Hide Arm/Group Description PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days. PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days. Placebo matched to PF-04447943 tablet was administered orally twice daily (BID) for up to 29 days.
All-Cause Mortality
PF-04447943 5 mg BID PF-04447943 25 mg BID Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
PF-04447943 5 mg BID PF-04447943 25 mg BID Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/7 (28.57%)   1/15 (6.67%)   0/7 (0.00%) 
Blood and lymphatic system disorders       
Sickle cell anaemia with crisis * 1  1/7 (14.29%)  1/15 (6.67%)  0/7 (0.00%) 
Hepatobiliary disorders       
Biliary colic * 1  1/7 (14.29%)  0/15 (0.00%)  0/7 (0.00%) 
Infections and infestations       
Pneumonia * 1  0/7 (0.00%)  1/15 (6.67%)  0/7 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 19.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PF-04447943 5 mg BID PF-04447943 25 mg BID Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/7 (100.00%)   13/15 (86.67%)   7/7 (100.00%) 
Blood and lymphatic system disorders       
Anaemia * 1  0/7 (0.00%)  1/15 (6.67%)  0/7 (0.00%) 
Sickle cell anaemia with crisis * 1  0/7 (0.00%)  1/15 (6.67%)  1/7 (14.29%) 
Congenital, familial and genetic disorders       
Sickle cell anaemia * 1  0/7 (0.00%)  2/15 (13.33%)  0/7 (0.00%) 
Eye disorders       
Ocular icterus * 1  0/7 (0.00%)  1/15 (6.67%)  0/7 (0.00%) 
Gastrointestinal disorders       
Abdominal distension * 1  1/7 (14.29%)  0/15 (0.00%)  2/7 (28.57%) 
Abdominal pain * 1  0/7 (0.00%)  1/15 (6.67%)  0/7 (0.00%) 
Abdominal pain upper * 1  2/7 (28.57%)  0/15 (0.00%)  0/7 (0.00%) 
Constipation * 1  1/7 (14.29%)  0/15 (0.00%)  0/7 (0.00%) 
Diarrhoea * 1  0/7 (0.00%)  1/15 (6.67%)  0/7 (0.00%) 
Dyspepsia * 1  1/7 (14.29%)  0/15 (0.00%)  0/7 (0.00%) 
Nausea * 1  0/7 (0.00%)  1/15 (6.67%)  2/7 (28.57%) 
Sensitivity of teeth * 1  0/7 (0.00%)  1/15 (6.67%)  0/7 (0.00%) 
Vomiting * 1  0/7 (0.00%)  0/15 (0.00%)  1/7 (14.29%) 
General disorders       
Chest discomfort * 1  0/7 (0.00%)  1/15 (6.67%)  0/7 (0.00%) 
Fatigue * 1  2/7 (28.57%)  6/15 (40.00%)  2/7 (28.57%) 
Gait disturbance * 1  0/7 (0.00%)  0/15 (0.00%)  1/7 (14.29%) 
Pain * 1  1/7 (14.29%)  1/15 (6.67%)  1/7 (14.29%) 
Peripheral swelling * 1  0/7 (0.00%)  0/15 (0.00%)  1/7 (14.29%) 
Pyrexia * 1  1/7 (14.29%)  1/15 (6.67%)  0/7 (0.00%) 
Tenderness * 1  0/7 (0.00%)  0/15 (0.00%)  1/7 (14.29%) 
Hepatobiliary disorders       
Jaundice * 1  0/7 (0.00%)  2/15 (13.33%)  1/7 (14.29%) 
Immune system disorders       
Seasonal allergy * 1  0/7 (0.00%)  0/15 (0.00%)  1/7 (14.29%) 
Infections and infestations       
Nasopharyngitis * 1  1/7 (14.29%)  1/15 (6.67%)  1/7 (14.29%) 
Rhinitis * 1  0/7 (0.00%)  1/15 (6.67%)  0/7 (0.00%) 
Upper respiratory tract infection * 1  0/7 (0.00%)  1/15 (6.67%)  0/7 (0.00%) 
Urinary tract infection * 1  0/7 (0.00%)  1/15 (6.67%)  0/7 (0.00%) 
Injury, poisoning and procedural complications       
Laceration * 1  0/7 (0.00%)  0/15 (0.00%)  1/7 (14.29%) 
Investigations       
Aspartate aminotransferase increased * 1  1/7 (14.29%)  0/15 (0.00%)  0/7 (0.00%) 
Blood pressure systolic increased * 1  1/7 (14.29%)  0/15 (0.00%)  0/7 (0.00%) 
Neutrophil count decreased * 1  0/7 (0.00%)  0/15 (0.00%)  1/7 (14.29%) 
Urine analysis abnormal * 1  0/7 (0.00%)  1/15 (6.67%)  0/7 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  0/7 (0.00%)  2/15 (13.33%)  0/7 (0.00%) 
Back pain * 1  0/7 (0.00%)  2/15 (13.33%)  1/7 (14.29%) 
Bone pain * 1  1/7 (14.29%)  0/15 (0.00%)  0/7 (0.00%) 
Limb discomfort * 1  0/7 (0.00%)  1/15 (6.67%)  0/7 (0.00%) 
Neck pain * 1  0/7 (0.00%)  1/15 (6.67%)  0/7 (0.00%) 
Pain in extremity * 1  0/7 (0.00%)  2/15 (13.33%)  0/7 (0.00%) 
Nervous system disorders       
Dizziness * 1  0/7 (0.00%)  3/15 (20.00%)  0/7 (0.00%) 
Headache * 1  4/7 (57.14%)  5/15 (33.33%)  2/7 (28.57%) 
Lethargy * 1  0/7 (0.00%)  1/15 (6.67%)  0/7 (0.00%) 
Migraine * 1  0/7 (0.00%)  1/15 (6.67%)  0/7 (0.00%) 
Poor quality sleep * 1  0/7 (0.00%)  1/15 (6.67%)  0/7 (0.00%) 
Somnolence * 1  0/7 (0.00%)  1/15 (6.67%)  0/7 (0.00%) 
Psychiatric disorders       
Insomnia * 1  0/7 (0.00%)  1/15 (6.67%)  0/7 (0.00%) 
Renal and urinary disorders       
Chromaturia * 1  0/7 (0.00%)  1/15 (6.67%)  0/7 (0.00%) 
Reproductive system and breast disorders       
Dysmenorrhoea * 1  0/7 (0.00%)  1/15 (6.67%)  0/7 (0.00%) 
Priapism * 1  1/7 (14.29%)  0/15 (0.00%)  0/7 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea * 1  0/7 (0.00%)  0/15 (0.00%)  1/7 (14.29%) 
Oropharyngeal pain * 1  0/7 (0.00%)  2/15 (13.33%)  0/7 (0.00%) 
Wheezing * 1  1/7 (14.29%)  0/15 (0.00%)  0/7 (0.00%) 
Skin and subcutaneous tissue disorders       
Dermatitis atopic * 1  0/7 (0.00%)  1/15 (6.67%)  0/7 (0.00%) 
Pruritus * 1  0/7 (0.00%)  1/15 (6.67%)  0/7 (0.00%) 
Vascular disorders       
Pallor * 1  0/7 (0.00%)  2/15 (13.33%)  1/7 (14.29%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 19.0
[Not Specified]
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02114203    
Other Study ID Numbers: B0401016
2014-001677-13 ( EudraCT Number )
First Submitted: April 7, 2014
First Posted: April 15, 2014
Results First Submitted: July 17, 2017
Results First Posted: December 14, 2017
Last Update Posted: December 14, 2017