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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01350141
First Posted: May 9, 2011
Last Update Posted: November 8, 2017
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.
Information provided by (Responsible Party):
Pfizer
  Purpose
PF-04950615 is a new investigational hypercholesterolemic agent that is being tested in this study to evaluate if it can lower LDL cholesterol.

Condition Intervention Phase
Hypercholesterolemia Dyslipidemia Other: Placebo Drug: PF-04950615 (RN316) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 85 [ Time Frame: 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:
  • Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than 70 and Less Than 100 Milligram Per Deciliter (mg/dL) [ Time Frame: Day 29, 57, 85 ]
  • Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C) [ Time Frame: Day 29, 57, 85 ]
  • Change From Baseline in Lipid Parameters at Day 29, 57 and 85 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.

  • Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters [ Time Frame: 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) [ Time Frame: 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.


Enrollment: 46
Actual Study Start Date: June 2011
Study Completion Date: June 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Treatment A Other: Placebo
An infusion lasting approximately 60 minutes
Experimental: Treatment B Drug: PF-04950615 (RN316)
An infusion lasting approximately 60 minutes
Experimental: Treatment C Drug: PF-04950615 (RN316)
An infusion lasting approximately 60 minutes

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01350141


  Show 35 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01350141     History of Changes
Other Study ID Numbers: B1481012
First Submitted: May 3, 2011
First Posted: May 9, 2011
Results First Submitted: October 2, 2017
Results First Posted: November 8, 2017
Last Update Posted: November 8, 2017
Last Verified: October 2017

Keywords provided by Pfizer:
Hypercholesterolemia
dyslipidemia
high cholesterol
LDL
antibody
PCSK9
PF-04950615
RN316

Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases