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

Hypercholesterolemia Clinical Trial

Official title:

A Phase 2, Double-blind, Placebo-controlled, Randomized Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 Following Multiple Intravenous Doses In Hypercholesterolemic Subjects On Maximum Dose Of Atorvastatin Or Rosuvastatin.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01350141
• Other study ID #: B1481012
• Status: Completed
• Phase: Phase 2
• First received: May 3, 2011
• Last updated: October 4, 2017
• Start date: June 2011
• Est. completion date: June 2012

Study information

• Verified date: October 2017
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Hypercholesterolemia

Intervention

Other:
• Placebo
An infusion lasting approximately 60 minutes

Drug:
• PF-04950615 (RN316)
An infusion lasting approximately 60 minutes
• PF-04950615 (RN316)
An infusion lasting approximately 60 minutes

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline, Day 85
Secondary	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
Secondary	Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C)		Day 29, 57, 85
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.	Baseline, Day 29, 57, 85
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.	Baseline, Day 29, 57, 85
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.	Day 1 up to Day 141
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.	Day 1 up to Day 141
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.	Screening up to Day 141
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.	Screening up to Day 141
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.	Day 1 up to Day 141

External Links

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