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A Multiple Dose Study of PF-04950615 (RN316) in Subjects on High Doses of Statins

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ClinicalTrials.gov Identifier: NCT01342211
Recruitment Status : Completed
First Posted : April 27, 2011
Results First Posted : October 11, 2017
Last Update Posted : October 11, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE April 25, 2011
First Posted Date  ICMJE April 27, 2011
Results First Submitted Date  ICMJE September 8, 2017
Results First Posted Date  ICMJE October 11, 2017
Last Update Posted Date October 11, 2017
Actual Study Start Date  ICMJE July 2011
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 25, 2011)
Observed mean percentage reduction from baseline in LDL-C [ Time Frame: Day 85 ]
Change History Complete list of historical versions of study NCT01342211 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2017)
  • Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <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, SAEs 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 attributed to study drug in a participant who received study drug. Investigator assessed TEAEs as mild (did not interfere with participant's usual function), moderate (interfered to some extent with participant's usual function) or severe (interfered significantly with participant's usual function). 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 Relevant Laboratory Abnormalities [ Time Frame: Day 1 up to Day 141 ]
    Hematology (hemoglobin[hgb],hematocrit,red blood cell[RBC]<0.8*lower limit of normal[LLN],mean cell[MC] volume,MC hgb,MC hg concentration <0.9*LLN, greater than[>] 1.1*upper limit of normal[ULN], platelet <0.5*LLN,>1.75*ULN, white blood cell[WBC]<0.6*LLN,>1.5*ULN,neutrophil,lymphocyte <0.8*LLN,>1.2*ULN,eosinophil,basophil,monocyte >1.2*ULN);chemistry(total, direct, indirect bilirubin[BR]>1.5*ULN,aspartate aminotransferase[AT],alanine AT,alkaline phosphatase,gamma-glutyl transferase>3.0*ULN,protein,lactate dehydrogenase <0.8*LLN,>1.2*ULN,creatinine,blood urea nitrogen>1.3*ULN,uric acid >1.2*ULN,potassium,chloride,calcium,bicarbonate<0.9*LLN,>1.1*ULN, sodium<0.95*LLN,>1.05*ULN,glucose[GL]<0.6*LLN,>1.5*ULN,amylase,lipase >1.5*ULN,creatinine kinase>2.0*ULN);urinalysis(pH <4.5,>8,specific gravity<1.003 , >1.030, GL,ketone,protein,hgb,BR,nitrite,leukocyte greater than or equal to [>=]1, RBC, WBC >=20);coagulation(prothrombin[PT],PT international ratio,partial thromboplastin time>1.1*ULN).
  • Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters [ Time Frame: Day 1 up to Day 141 ]
    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 >200 millisecond (msec) and 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 >30 to <=60 msec and maximum increase from baseline of >60 msec for QT interval corrected using the Fridericia's formula (QTCF).
  • Number of Participants With Anti-drug Antibody (ADA) [ Time Frame: Day 1 up to Day 141 ]
    Human serum ADA samples of participants who received PF-04950615 (RN316) were analyzed for the presence of anti-PF-04950615 (RN316) 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2011)
  • Proportion of subjects achieving a significant decrease in LDL C from baseline. [ Time Frame: Day 85 ]
  • Change and percentage change from baseline in other lipid parameters: total cholesterol, HDL C, non-HDL C, TG, ApoB, ApoA1 and Lpa. [ Time Frame: Day 85 ]
  • Incidence, severity and causal relationship of treatment emergent AEs (TEAEs). [ Time Frame: Day 141 ]
  • Incidence of abnormal and clinically relevant safety laboratories including clinical chemistry, hematology and coagulation assessments. [ Time Frame: Day 141 ]
  • Abnormal and clinically relevant changes in vital signs, BP, and ECG parameters. [ Time Frame: Day 141 ]
  • Incidence of anti-drug-antibodies. [ Time Frame: Day 141 ]
Current Other Pre-specified Outcome Measures
 (submitted: September 11, 2017)
  • Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 [ Time Frame: Baseline, Day 29, 57, 71, 85, 99, 127, 141 ]
    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 Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 [ Time Frame: Baseline, Day 29, 57, 71, 85, 99, 127, 141 ]
    Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Multiple Dose Study of PF-04950615 (RN316) in Subjects on High Doses of Statins
Official Title  ICMJE 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 High Doses Of Atorvastatin, Rosuvastatin Or Simvastatin.
Brief Summary This study will investigate the effect of PF-04950615, a new investigational lipid lowering agent, on LDL-C and other lipids.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypercholesterolemia
  • Dyslipidemia
Intervention  ICMJE
  • Biological: Placebo
    Intravenous placebo monthly during treatment phase.
  • Drug: Statin
    Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET.
  • Biological: PF-04950615 (RN316)
    Intravenous 10mg/mL based on weight monthly during treatment phase.
  • Drug: Satin
    Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET.
Study Arms  ICMJE
  • Placebo Comparator: Treatment A
    Interventions:
    • Biological: Placebo
    • Drug: Statin
  • Experimental: Treatment B
    Interventions:
    • Biological: PF-04950615 (RN316)
    • Drug: Statin
  • Experimental: Treatment C
    Interventions:
    • Biological: PF-04950615 (RN316)
    • Drug: Statin
  • Experimental: Treatment D
    Interventions:
    • Biological: PF-04950615 (RN316)
    • Drug: Satin
  • Experimental: Treatment E
    Interventions:
    • Biological: PF-04950615 (RN316)
    • Drug: Statin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 16, 2013)
93
Original Estimated Enrollment  ICMJE
 (submitted: April 25, 2011)
90
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • On a stable daily dose of atorvastatin, rosuvastatin or simvastatin.
  • Lipids meet the following criteria at screening and prior to dosing: Fasting LDL-C greater than 100 mg/dL and fasting TG less than 400 mg/dL

Exclusion Criteria:

  • History of a cardiovascular or cerebrovascular event or procedure during the past year.
  • Poorly controlled type 1 or type 2 diabetes mellitus.
  • Poorly controlled hypertension.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01342211
Other Study ID Numbers  ICMJE B1481005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP