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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001677-13 | EudraCT Number |
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This study is being conducted to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of an investigational drug, PF-04447943, in subjects with stable sickle cell disease with and without co-administration with hydroxyurea. This study will also aid in selecting the doses for future studies and evaluation of substances in the blood which may help access the effectiveness of the drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cohort 1 PF-04447943 | Experimental |
| |
| cohort 2 PF-04447943 | Experimental |
| |
| placebo comparator | Placebo Comparator |
| |
| optional cohort of PF-04447943 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PDE9i | Drug | oral dose, every 12 hours for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Potentially Clinically Important (PCI) Change From Baseline in Vital Signs | 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. | Baseline up to 30 days post last dose on Day 29 |
| Number of Participants With Potentially Clinically Important (PCI) Change From Baseline in Neurologic Function | 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. | Baseline up to Day 29 |
| Number of Participants With Potentially Clinically Important (PCI) Change in Physical Examination Findings | 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. | Baseline up to 30 days post last dose on Day 29 |
| Number of Participants With Clinically Significant Treatment-Emergent Electrocardiogram (ECG) Findings | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to 12 Hours Post Dose (AUC(0-12h)) of PF-04447943 | AUC(0-12h) referred to area under the plasma concentration-time curve from 0 to 12 hours post dose. | Prior to 0 hour, and 0.5, 1, 2, 4, 8, and 12 hours post dose on Day 1 |
| Maximum Observed Plasma Concentration (Cmax) of PF-04447943 |
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Inclusion Criteria:
Exclusion Criteria:
History of a recent major surgery, within 3 months of baseline visit.
Serious infection (requiring hospitalization or parenteral antibiotics) within 1 month of baseline visit.
History of cerebrovascular accident or seizure disorder.
Subjects with a history of clinically significant orthostatic blood pressure (BP) changes or clinically significant orthostatic symptoms.
Known previous diagnosis of acute hepatitis of any aetiology Hepatitis B or C or Human immunodeficiency virus (HIV) infection.
History of any malignancy except for subjects who had a basal or squamous cell cancer which has been treated and fully resolved for a minimum of 5 years.
History or evidence of cardiac disease including: myocardial infarction, cardiac arrhythmia
Systemic therapy with any of the following medications that are strong or moderate CYP3A4 inhibitors within 7 days or 5 half-lives (whichever is longer) or CYP3A inducers within 28 days prior to the first dose of the trial medication, or during the trial.
Use of PDE5 inhibitors within 7 days prior to the first dose of the trial medication, or at any time during the trial.
Creatinine clearance <30ml/min.
Hemoglobin level <6 gm/dL.
Alanine transaminase (ALT/SGPT) and Aspartate aminotransferase (AST/SGOT) >2x upper limit of normal, (based on clinic laboratory normal range).
Any condition possibly affecting drug absorption (eg, gastrectomy).
A positive urine drug screen for illicit drug.
History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of Screening.
Treatment with an investigational drug within 2 months (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
12-lead ECG demonstrating QTc >450 or a QRS interval >120 msec msec at Screening.
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
A family history of long QT syndrome and/or ECG abnormalities at screening or randomization, including those listed below:
Use of concomitant medications that prolong the QT/QTc interval
Pregnant females and, breast feeding females and females of childbearing potential; male and female subjects of childbearing potential who are unwilling or unable to use highly effective methods of contraception as outlined in this protocol for the duration of the study and for at least 30 days after the last dose of investigational product.
Subjects who lack the capacity to consent for themselves.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois Hospital and Health Sciences System | Chicago | Illinois | 60612-5836 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30597771 | Derived | Charnigo RJ, Beidler D, Rybin D, Pittman DD, Tan B, Howard J, Michelson AD, Frelinger AL , III, Clarke N. PF-04447943, a Phosphodiesterase 9A Inhibitor, in Stable Sickle Cell Disease Patients: A Phase Ib Randomized, Placebo-Controlled Study. Clin Transl Sci. 2019 Mar;12(2):180-188. doi: 10.1111/cts.12604. Epub 2018 Dec 31. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | PF-04447943 5 mg BID | PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days. |
| FG001 | PF-04447943 25 mg BID | PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| PDE9i | Drug | oral dose, every 12 hours for 28 days |
|
| placebo for PDE9i | Drug | oral dose, every 12 hours for 28 days |
|
| PDE9i | Drug | oral dose, every 12 hours for 28 days |
|
| Baseline up to 30 days post last dose on Day 29 |
| Number of Participants With Potentially Clinically Important (PCI) Change From Baseline in Symptoms of Sickle Cell Disease | 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. | Baseline up to 30 days post last dose on Day 29 |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | 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. | Day 1 to 30 days post last dose on Day 29 |
| Number of Participants With Laboratory Test Abnormalities | 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. | Baseline up to 30 days post last dose on Day 29 |
| Prior to 0 hour, and 0.5, 1, 2, 4, 8, and 12 hours post dose on Day 1 |
| Time for Maximum Observed Plasma Concentration (Tmax) of PF-04447943 | Prior to 0 hour, and 0.5, 1, 2, 4, 8, and 12 hours post dose on Day 1 |
| University of Illinois at Chicago Clinical Research Center |
| Chicago |
| Illinois |
| 60612 |
| United States |
| University of Illinois Hospital and Health Sciences System | Chicago | Illinois | 60612 | United States |
| Boston Medical Center E7E | Boston | Massachusetts | 02118 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| Boston University Medical Center | Boston | Massachusetts | 02118 | United States |
| Interfaith Medical Center | Brooklyn | New York | 11213 | United States |
| Interfaith Medical Center | Brooklyn | New York | 11238 | United States |
| UNC Hospitals' Investigational Drug Service Pharmacy | Chapel Hill | North Carolina | 27514 | United States |
| UNC School of Medicine Clinical and Translational Research Center | Chapel Hill | North Carolina | 27599 | United States |
| Investigational Drug Services | Richmond | Virginia | 23298 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| Pfizer Clinical Research Unit | Brussels | B-1070 | Belgium |
| Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico | Milan | 20122 | Italy |
| A.O.O.R Villa Sofia - V. Cervello | Palermo | 90146 | Italy |
| Centre for Human Drug Research | Leiden | 2333 CL | Netherlands |
| Royal Liverpool and Broadgreen University Hospital Trust | Liverpool | Merseyside | L7 8XP | United Kingdom |
| Guy's and St Thomas' NHS Foundation Trust | London | SE1 9RT | United Kingdom |
| King's College Hospital NHS Foundation Trust | London | SE5 9RS | United Kingdom |
| Imperial College Healthcare NHS Trust | London | W12 0HS | United Kingdom |
| Central Manchester University Hospitals NHS Foundation Trust | Manchester | M13 9WL | United Kingdom |
| Manchester Royal Infirmary | Manchester | M13 9WL | United Kingdom |
| Oxford University Hospitals NHS Trust | Oxford | OX3 7LE | United Kingdom |
| FG002 | Placebo | Placebo matched to PF-04447943 tablet was administered orally twice daily (BID) for up to 29 days. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline analysis population included all participants who were randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | PF-04447943 5 mg BID | PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days. |
| BG001 | PF-04447943 25 mg BID | PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days. |
| BG002 | Placebo | Placebo matched to PF-04447943 tablet was administered orally twice daily (BID) for up to 29 days. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Potentially Clinically Important (PCI) Change From Baseline in Vital Signs | 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. | The safety analysis population was defined as all participants who received at least 1 dose of study medication. | Posted | Number | participants | Baseline up to 30 days post last dose on Day 29 |
|
|
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Potentially Clinically Important (PCI) Change From Baseline in Neurologic Function | 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. | The safety analysis population was defined as all participants who received at least 1 dose of study medication. | Posted | Number | participants | Baseline up to Day 29 |
|
| |||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Potentially Clinically Important (PCI) Change in Physical Examination Findings | 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. | The safety analysis population was defined as all participants who received at least 1 dose of study medication. | Posted | Number | participants | Baseline up to 30 days post last dose on Day 29 |
|
| |||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Clinically Significant Treatment-Emergent Electrocardiogram (ECG) Findings | 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. | The safety analysis population was defined as all participants who received at least 1 dose of study medication. | Posted | Number | participants | Baseline up to 30 days post last dose on Day 29 |
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Potentially Clinically Important (PCI) Change From Baseline in Symptoms of Sickle Cell Disease | 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. | The safety analysis population was defined as all participants who received at least 1 dose of study medication. | Posted | Number | participants | Baseline up to 30 days post last dose on Day 29 |
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | 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. | The safety analysis population was defined as all participants who received at least 1 dose of study medication. | Posted | Number | participants | Day 1 to 30 days post last dose on Day 29 |
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Laboratory Test Abnormalities | 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. | The safety analysis population was defined as all participants who received at least 1 dose of study medication. | Posted | Number | participants | Baseline up to 30 days post last dose on Day 29 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Area Under the Curve From Time Zero to 12 Hours Post Dose (AUC(0-12h)) of PF-04447943 | AUC(0-12h) referred to area under the plasma concentration-time curve from 0 to 12 hours post dose. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour/milliliter | Prior to 0 hour, and 0.5, 1, 2, 4, 8, and 12 hours post dose on Day 1 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Maximum Observed Plasma Concentration (Cmax) of PF-04447943 | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Prior to 0 hour, and 0.5, 1, 2, 4, 8, and 12 hours post dose on Day 1 |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Time for Maximum Observed Plasma Concentration (Tmax) of PF-04447943 | 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. | Posted | Median | Full Range | hours | Prior to 0 hour, and 0.5, 1, 2, 4, 8, and 12 hours post dose on Day 1 |
|
|
Day 1 to follow-up visit (30 days post last dose on Day 29)
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PF-04447943 5 mg BID | PF-04447943 tablet was administered orally at 5 mg twice daily (BID) for up to 29 days. | 2 | 7 | 7 | 7 | ||
| EG001 | PF-04447943 25 mg BID | PF-04447943 tablet was administered orally at 25 mg twice daily (BID) for up to 29 days. | 1 | 15 | 13 | 15 | ||
| EG002 | Placebo | Placebo matched to PF-04447943 tablet was administered orally twice daily (BID) for up to 29 days. | 0 | 7 | 7 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sickle cell anaemia with crisis | Blood and lymphatic system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Biliary colic | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Sickle cell anaemia with crisis | Blood and lymphatic system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Sickle cell anaemia | Congenital, familial and genetic disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Ocular icterus | Eye disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Sensitivity of teeth | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Tenderness | General disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Blood pressure systolic increased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Urine analysis abnormal | Investigations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Poor quality sleep | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Chromaturia | Renal and urinary disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Priapism | Reproductive system and breast disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pallor | Vascular disorders | MedDRA 19.0 | Non-systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Male |
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| Maximum decrease in supine SBP >=30 mmHg |
|
| Maximum decrease in supine DBP >=20 mmHg |
|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|
| OG002 | Placebo | Placebo matched to PF-04447943 tablet was administered orally twice daily (BID) for up to 29 days. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Placebo matched to PF-04447943 tablet was administered orally twice daily (BID) for up to 29 days. |
|
|
| OG002 | Placebo | Placebo matched to PF-04447943 tablet was administered orally twice daily (BID) for up to 29 days. |
|
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|
|
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