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PF-04950615 is a new investigational hypercholesterolemic agent that is being tested in this study to evaluate if it can lower LDL cholesterol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Placebo Comparator |
| |
| Treatment B | Experimental |
| |
| Treatment C | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | An infusion lasting approximately 60 minutes |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 85 | Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration. | Baseline, Day 85 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than 70 and Less Than 100 Milligram Per Deciliter (mg/dL) | Day 29, 57, 85 | |
| Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Achieve Clinical Research, LLC | Birmingham | Alabama | 35216 | United States | ||
| Advance Outcome Management, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37994400 | Derived | Wang EQ, Kaila N, Plowchalk D, Gibiansky L, Yunis C, Sweeney K. Population PK/PD modeling of low-density lipoprotein cholesterol response in hypercholesterolemic participants following administration of bococizumab, a potent anti-PCSK9 monoclonal antibody. CPT Pharmacometrics Syst Pharmacol. 2023 Dec;12(12):2013-2026. doi: 10.1002/psp4.13050. Epub 2023 Nov 22. | |
| 29037448 |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received single intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin 80 milligram (mg) tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141. |
| FG001 | PF-04950615 (RN316) 1 mg/kg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| PF-04950615 (RN316) |
| Drug |
An infusion lasting approximately 60 minutes |
|
| PF-04950615 (RN316) | Drug | An infusion lasting approximately 60 minutes |
|
| Day 29, 57, 85 |
| Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Lipid parameters included: high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), non-high-density lipoprotein-cholesterol (non-HDL-C), triglyceride (TG), apolipoprotein B (ApoB) and apolipoprotein A1 (ApoA1). Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration. | Baseline, Day 29, 57, 85 |
| Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Lipid parameters included: high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), non-high-density lipoprotein-cholesterol (non-HDL-C), triglyceride (TG), apolipoprotein B (ApoB) and apolipoprotein A1 (ApoA1). Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration. | Baseline, Day 29, 57, 85 |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are events between first dose of study drug and up to Day 141 that were absent before treatment or that worsened relative to pretreatment state. Treatment related: a TEAE deemed related to the study drug by the investigator. TEAEs included SAEs (TESAEs) as well as non-serious AEs which occurred during the study. The participants with TEAEs, TESAEs and treatment-related TEAEs were reported. | Day 1 up to Day 141 |
| Number of Treatment-Emergent Adverse Events (TEAEs) by Severity | An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Investigator assessed adverse events as mild (does not interfere with participant's usual function), moderate (interferes to some extent with participant's usual function) or severe (interferes significantly with participant's usual function). All causality TEAEs were assessed for severity. TEAEs are events between first dose of study drug and up to Day 141 that were absent before treatment or that worsened relative to pretreatment state. | Day 1 up to Day 141 |
| Number of Participants With Clinically Significant Laboratory Abnormalities | Criteria for clinically significant laboratory abnormalities were based on investigator's discretion. Total number of participants who met the criteria for any laboratory abnormal findings were reported. Laboratory parameters included: hematology, coagulation, liver function, renal function, electrolytes, hormones, chemistry and urinalysis. Screening was 21 days prior to start of study treatment. | Screening up to Day 141 |
| Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | Number of participants with clinically significant changes in vital signs and ECG findings were reported. Criteria for clinical significant vital signs: maximum increase or decrease from baseline in supine systolic blood pressure (BP) greater than or equal to (>=) 30 millimeter of mercury (mmHg), maximum increase or decrease from baseline in supine diastolic BP of >=20 mmHg. Criteria for clinically significant ECG parameters: maximum increase of >=25 percent (%) for baseline value of greater than 200 millisecond (msec) or maximum increase of >=50% for baseline value of less than or equal to (<=) 200 msec for PR and QRS interval, maximum increase from baseline of greater than (>) 30 to <=60 msec and maximum increase from baseline of >60 msec for QT interval corrected using the Fridericia's formula (QTCF). Screening was 21 days prior to start of study treatment. | Screening up to Day 141 |
| Number of Participants With Anti-drug (Anti-PF-04950615) Antibody (ADA) | Human serum samples of participants who received PF-04950615 (RN316) were analyzed for the presence of anti-PF-04950615 antibodies by using the semi quantitative enzyme-linked immunosorbent assay (ELISA). Results with titer value >=4.32 nanogram per milliliter of anti-PF-04950615 antibodies were counted as positive. Number of participants with presence of anti-PF-04950615 antibodies were reported in this outcome measure. | Day 1 up to Day 141 |
| Garden Grove |
| California |
| 92845 |
| United States |
| Collaborative Neuroscience Network, Inc | Garden Grove | California | 92845 | United States |
| Collaborative Neuroscience Network, Inc. | Long Beach | California | 90806 | United States |
| Elite Clinical Trials, Inc. | Wildomar | California | 92595 | United States |
| Innovative Research of West Florida, Inc. | Clearwater | Florida | 33756 | United States |
| Avail Clinical Research, LLC | DeLand | Florida | 32720 | United States |
| Kendall South Medical Center, Inc. | Miami | Florida | 33185 | United States |
| Compass Research, LLC | Orlando | Florida | 32806 | United States |
| Atlanta Diabetes Associates | Atlanta | Georgia | 30309 | United States |
| Midwest Cardiology Associates | Overland Park | Kansas | 66209 | United States |
| Stark Pharmacy | Overland Park | Kansas | 66209 | United States |
| Vince and Associates Clinical Research | Overland Park | Kansas | 66212 | United States |
| Saint Luke's Hospital | Kansas City | Missouri | 64111 | United States |
| Saint Luke's Lipid and Diabetes Research Center | Kansas City | Missouri | 64111 | United States |
| Advance Clinical Research | St Louis | Missouri | 63128 | United States |
| Wake Internal Medicine Consultants, Inc. | Raleigh | North Carolina | 27612 | United States |
| Wake Research Associates, LLC | Raleigh | North Carolina | 27612 | United States |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | United States |
| Oklahoma Cardiovascular Research Group | Oklahoma City | Oklahoma | 73120 | United States |
| Oklahoma Heart Hospital Physicians | Oklahoma City | Oklahoma | 73120 | United States |
| Oklahoma Heart Hospital | Oklahoma City | Oklahoma | 73120 | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| DeGarmo Institute of Medical Research | Greer | South Carolina | 29651 | United States |
| Holston Medical Group | Kingsport | Tennessee | 37660 | United States |
| Texas Center for Drug Development, Inc | Houston | Texas | 77081 | United States |
| Martin Diagnostic Clinic | Tomball | Texas | 77375 | United States |
| Aspen Clinical Research, LLC | Orem | Utah | 84058 | United States |
| National Clinical Research - Richmond, Inc. | Richmond | Virginia | 23294 | United States |
| The Medical Arts Health Research Group | Kelowna | British Columbia | V1Y 3G8 | Canada |
| Q & T Research Chicoutimi | Chicoutimi | Quebec | G7H 7Y8 | Canada |
| Centre de Recherche Clinique de Laval | Laval | Quebec | H7T 2P5 | Canada |
| Diex Research Montreal Inc. | Montreal | Quebec | H4N 3C5 | Canada |
| Clinique des Maladies Lipidiques de Quebec Inc. | Québec | Quebec | G1V 4M6 | Canada |
| Diex Research Sherbrooke Inc. | Sherbrooke | Quebec | J1H 1Z1 | Canada |
| Wan H, Gumbiner B, Joh T, Riel T, Udata C, Forgues P, Garzone PD. Effects of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition with Bococizumab on Lipoprotein Particles in Hypercholesterolemic Subjects. Clin Ther. 2017 Nov;39(11):2243-2259.e5. doi: 10.1016/j.clinthera.2017.09.009. Epub 2017 Oct 14. |
| 28181260 | Derived | Udata C, Garzone PD, Gumbiner B, Joh T, Liang H, Liao KH, Williams JH, Meng X. A Mechanism-Based Pharmacokinetic/Pharmacodynamic Model for Bococizumab, a Humanized Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9, and Its Application in Early Clinical Development. J Clin Pharmacol. 2017 Jul;57(7):855-864. doi: 10.1002/jcph.867. Epub 2017 Feb 9. |
Participants received single intravenous infusion of PF-04950615 (RN316) 1 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141. |
| FG002 | PF-04950615 (RN316) 3 mg/kg | Participants received single intravenous infusion of PF-04950615 (RN316) 3 mg/kg on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety analysis set included all participants who received at least 1 dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received single intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin 80 milligram (mg) tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141. |
| BG001 | PF-04950615 (RN316) 1 mg/kg | Participants received single intravenous infusion of PF-04950615 (RN316) 1 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141. |
| BG002 | PF-04950615 (RN316) 3 mg/kg | Participants received single intravenous infusion of PF-04950615 (RN316) 3 mg/kg on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141. |
| 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 | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 85 | Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration. | Efficacy analysis set included all participants who received at least 1 dose of study medication and completed the Day 85 visit or dropped out prematurely, whichever was earlier. "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 85 |
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| Secondary | Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than 70 and Less Than 100 Milligram Per Deciliter (mg/dL) | Efficacy analysis set. "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure and "Number of participants analyzed" signifies those participants who were evaluable for this measure at given time points, for each group respectively. | Posted | Number | Percentage of participants | Day 29, 57, 85 |
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| Secondary | Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C) | Efficacy analysis set. "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure and "Number of Participants Analyzed" signifies those participants who were evaluable for this measure at given time points, for each group respectively. | Posted | Number | percentage of participants | Day 29, 57, 85 |
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| Secondary | Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Lipid parameters included: high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), non-high-density lipoprotein-cholesterol (non-HDL-C), triglyceride (TG), apolipoprotein B (ApoB) and apolipoprotein A1 (ApoA1). Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration. | Efficacy analysis set. 'Number of participants analyzed' = participants who were evaluable for this measure at given time points for each arm. Results for change at Day 85 for ApoB and ApoA1 were not reported as data was not collected for ApoB and ApoA1 at Day 85 due to an inadvertent omission in the protocol. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Day 29, 57, 85 |
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| Secondary | Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85 | Lipid parameters included: high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), non-high-density lipoprotein-cholesterol (non-HDL-C), triglyceride (TG), apolipoprotein B (ApoB) and apolipoprotein A1 (ApoA1). Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration. | Efficacy analysis set. "Number of participants analyzed" = participants who were evaluable for this measure at given time points for each arm. Results for percent change at Day 85 for ApoB and ApoA1 were not reported as data was not collected for ApoB and ApoA1 at Day 85 due to an inadvertent omission in the protocol. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 29, 57, 85 |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are events between first dose of study drug and up to Day 141 that were absent before treatment or that worsened relative to pretreatment state. Treatment related: a TEAE deemed related to the study drug by the investigator. TEAEs included SAEs (TESAEs) as well as non-serious AEs which occurred during the study. The participants with TEAEs, TESAEs and treatment-related TEAEs were reported. | Safety analysis set included all participants who received at least 1 dose of study medication. | Posted | Count of Participants | Participants | Day 1 up to Day 141 |
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| Secondary | Number of Treatment-Emergent Adverse Events (TEAEs) by Severity | An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Investigator assessed adverse events as mild (does not interfere with participant's usual function), moderate (interferes to some extent with participant's usual function) or severe (interferes significantly with participant's usual function). All causality TEAEs were assessed for severity. TEAEs are events between first dose of study drug and up to Day 141 that were absent before treatment or that worsened relative to pretreatment state. | Safety analysis set included all participants who received at least 1 dose of study medication. | Posted | Number | Treatment-emergent AEs | Day 1 up to Day 141 |
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| Secondary | Number of Participants With Clinically Significant Laboratory Abnormalities | Criteria for clinically significant laboratory abnormalities were based on investigator's discretion. Total number of participants who met the criteria for any laboratory abnormal findings were reported. Laboratory parameters included: hematology, coagulation, liver function, renal function, electrolytes, hormones, chemistry and urinalysis. Screening was 21 days prior to start of study treatment. | Safety analysis set included all participants who received at least 1 dose of study medication. | Posted | Count of Participants | Participants | Screening up to Day 141 |
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| Secondary | Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters | Number of participants with clinically significant changes in vital signs and ECG findings were reported. Criteria for clinical significant vital signs: maximum increase or decrease from baseline in supine systolic blood pressure (BP) greater than or equal to (>=) 30 millimeter of mercury (mmHg), maximum increase or decrease from baseline in supine diastolic BP of >=20 mmHg. Criteria for clinically significant ECG parameters: maximum increase of >=25 percent (%) for baseline value of greater than 200 millisecond (msec) or maximum increase of >=50% for baseline value of less than or equal to (<=) 200 msec for PR and QRS interval, maximum increase from baseline of greater than (>) 30 to <=60 msec and maximum increase from baseline of >60 msec for QT interval corrected using the Fridericia's formula (QTCF). Screening was 21 days prior to start of study treatment. | Safety analysis set included all participants who received at least 1 dose of study medication. | Posted | Count of Participants | Participants | Screening up to Day 141 |
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| Secondary | Number of Participants With Anti-drug (Anti-PF-04950615) Antibody (ADA) | Human serum samples of participants who received PF-04950615 (RN316) were analyzed for the presence of anti-PF-04950615 antibodies by using the semi quantitative enzyme-linked immunosorbent assay (ELISA). Results with titer value >=4.32 nanogram per milliliter of anti-PF-04950615 antibodies were counted as positive. Number of participants with presence of anti-PF-04950615 antibodies were reported in this outcome measure. | Analysis set included all participants who received at least 1 dose of PF-04950615 (RN316). | Posted | Number | participants | Day 1 up to Day 141 |
|
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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 nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received single intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin 80 milligram (mg) tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141. | 0 | 14 | 9 | 14 | ||
| EG001 | PF-04950615 (RN316) 1 mg/kg | Participants received single intravenous infusion of PF-04950615 (RN316) 1 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141. | 1 | 15 | 12 | 15 | ||
| EG002 | PF-04950615 (RN316) 3 mg/kg | Participants received single intravenous infusion of PF-04950615 (RN316) 3 mg/kg on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141. | 0 | 16 | 9 | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-cardiac chest pain | General disorders | MedDRA 15.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular block first degree | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Colitis microscopic | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
| |
| Blood cortisol decreased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Jaw cyst | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Essential tremor | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Neuralgic amyotrophy | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Breast tenderness | Reproductive system and breast disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Exfoliative rash | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
|
Due to an inadvertent omission in the protocol at Day 85, presented limitations in data collection and the assessment of treatment effect on ApoA1 and ApoB for Day 85.
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 |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000598888 | bococizumab |
Not provided
Not provided
Not provided
| Male |
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Analysis was performed using ANCOVA model with treatment, background statin as independent factors and treatment by background statin interaction, baseline LDL-C as covariate. |
| ANCOVA |
| <0.0001 |
| LS Mean Difference |
| -46.42 |
| Standard Error of the Mean |
| 8.463 |
| 2-Sided |
| 95 |
| -63.62 |
| -29.22 |
| Superiority or Other |
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| PF-04950615 (RN316) 3 mg/kg |
Participants received single intravenous infusion of PF-04950615 (RN316) 3 mg/kg on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141. |
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| PF-04950615 (RN316) 3 mg/kg |
Participants received single intravenous infusion of PF-04950615 (RN316) 3 mg/kg on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141. |
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| OG002 | PF-04950615 (RN316) 3 mg/kg | Participants received single intravenous infusion of PF-04950615 (RN316) 3 mg/kg on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141. |
|
|
| PF-04950615 (RN316) 3 mg/kg |
Participants received single intravenous infusion of PF-04950615 (RN316) 3 mg/kg on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141. |
|
|
Participants received single intravenous infusion of PF-04950615 (RN316) 3 mg/kg on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141.
|
|
| OG002 | PF-04950615 (RN316) 3 mg/kg | Participants received single intravenous infusion of PF-04950615 (RN316) 3 mg/kg on Day 1, 29 and 57 along with atorvastatin 80 mg tablet or rosuvastatin 40 mg tablet orally once daily from Day 1 to 141. |
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| Participants |
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