A Multiple Dose Study Of PF-04950615 (RN316) In Subjects On Maximum Doses Of Statins

Phase 2

Completed

Conditions: Hypercholesterolemia
Dyslipidemia

Interventions: Other: Placebo
Drug: PF-04950615 (RN316)

Registration Number: NCT01350141

Lead Sponsor: Pfizer

Brief Summary: PF-04950615 is a new investigational hypercholesterolemic agent that is being tested in this study to evaluate if it can lower LDL cholesterol.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 46

Inclusion Criteria

Body Mass Index (BMI) of 18.5 to 40 kg/m2
On a stable maximum daily dose of a statin, defined as atorvastatin 80 mg or rosuvastatin 40 mg for a minimum of 45 days prior to Day 1.
Lipids meet the following criteria twice during screening period:
Fasting LDL C = or > 80 mg/dL;
Fasting TG < 400 mg/dL.

Exclusion Criteria

History of a cardiovascular or cerebrovascular event or procedure (eg, MI, stroke, TIA, angioplasty) during the past year.
Poorly controlled type 1 or type 2 diabetes mellitus.
Poorly controlled hypertension.
Fasting triglycerides > 400 mg/dL
12 lead ECG demonstrating QTcFF >455 msec at screening.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment A	Placebo	-
Treatment B	PF-04950615 (RN316)	-
Treatment C	PF-04950615 (RN316)	-

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 85	Baseline, Day 85	Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.

Secondary Outcome Measures

Name	Time	Method
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)	Day 29, 57, 85
Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters	Screening up to Day 141	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.
Number of Participants With Anti-drug (Anti-PF-04950615) Antibody (ADA)	Day 1 up to Day 141	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.
Change From Baseline in Lipid Parameters at Day 29, 57 and 85	Baseline, Day 29, 57, 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.
Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85	Baseline, Day 29, 57, 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.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Day 1 up to Day 141	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.
Number of Treatment-Emergent Adverse Events (TEAEs) by Severity	Day 1 up to Day 141	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.
Number of Participants With Clinically Significant Laboratory Abnormalities	Screening up to Day 141	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.

Trial Locations

Locations (35): Atlanta Diabetes Associates
🇺🇸
Atlanta, Georgia, United States
Wake Research Associates, LLC
🇺🇸
Raleigh, North Carolina, United States
Kendall South Medical Center, Inc.
🇺🇸
Miami, Florida, United States
Midwest Cardiology Associates
🇺🇸
Overland Park, Kansas, United States
Wake Internal Medicine Consultants, Inc.
🇺🇸
Raleigh, North Carolina, United States
Stark Pharmacy
🇺🇸
Overland Park, Kansas, United States
Saint Luke's Lipid and Diabetes Research Center
🇺🇸
Kansas City, Missouri, United States
Altoona Center for Clinical Research
🇺🇸
Duncansville, Pennsylvania, United States
Holston Medical Group
🇺🇸
Kingsport, Tennessee, United States
Q & T Research Chicoutimi
🇨🇦
Chicoutimi, Quebec, Canada
Achieve Clinical Research, LLC
🇺🇸
Birmingham, Alabama, United States
Lynn Health Science Institute
🇺🇸
Oklahoma City, Oklahoma, United States
Oklahoma Cardiovascular Research Group
🇺🇸
Oklahoma City, Oklahoma, United States
Texas Center for Drug Development, Inc
🇺🇸
Houston, Texas, United States
Oklahoma Heart Hospital Physicians
🇺🇸
Oklahoma City, Oklahoma, United States
Collaborative Neuroscience Network, Inc.
🇺🇸
Long Beach, California, United States
Elite Clinical Trials, Inc.
🇺🇸
Wildomar, California, United States
Advance Outcome Management, Inc.
🇺🇸
Garden Grove, California, United States
Collaborative Neuroscience Network, Inc
🇺🇸
Garden Grove, California, United States
Avail Clinical Research, LLC
🇺🇸
DeLand, Florida, United States
Compass Research, LLC
🇺🇸
Orlando, Florida, United States
Saint Luke's Hospital
🇺🇸
Kansas City, Missouri, United States
Martin Diagnostic Clinic
🇺🇸
Tomball, Texas, United States
Vince and Associates Clinical Research
🇺🇸
Overland Park, Kansas, United States
Oklahoma Heart Hospital
🇺🇸
Oklahoma City, Oklahoma, United States
Advance Clinical Research
🇺🇸
Saint Louis, Missouri, United States
DeGarmo Institute of Medical Research
🇺🇸
Greer, South Carolina, United States
Aspen Clinical Research, LLC
🇺🇸
Orem, Utah, United States
The Medical Arts Health Research Group
🇨🇦
Kelowna, British Columbia, Canada
National Clinical Research - Richmond, Inc.
🇺🇸
Richmond, Virginia, United States
Centre de Recherche Clinique de Laval
🇨🇦
Laval, Quebec, Canada
Diex Research Montreal Inc.
🇨🇦
Montreal, Quebec, Canada
Clinique des Maladies Lipidiques de Quebec Inc.
🇨🇦
Quebec, Canada
Diex Research Sherbrooke Inc.
🇨🇦
Sherbrooke, Quebec, Canada
Innovative Research of West Florida, Inc.
🇺🇸
Clearwater, Florida, United States