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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT01342211

Collaborator

(none)

Enrollment

Locations

Arms

Actual Duration (Months)

2.1

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will investigate the effect of PF-04950615, a new investigational lipid lowering agent, on LDL-C and other lipids.

Condition or Disease	Intervention/Treatment	Phase
Hypercholesterolemia Dyslipidemia	Biological: Placebo Drug: Statin Biological: PF-04950615 (RN316) Drug: Statin Biological: PF-04950615 (RN316) Drug: Statin Biological: PF-04950615 (RN316) Drug: Satin Biological: PF-04950615 (RN316) Drug: Statin	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

93 participants

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 High Doses Of Atorvastatin, Rosuvastatin Or Simvastatin.

Actual Study Start Date :

Jul 1, 2011

Actual Primary Completion Date :

Feb 1, 2012

Actual Study Completion Date :

Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Treatment A	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.
Experimental: Treatment B	Biological: PF-04950615 (RN316) Intravenous 10mg/mL based on weight 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.
Experimental: Treatment C	Biological: PF-04950615 (RN316) Intravenous 10mg/mL based on weight 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.
Experimental: Treatment D	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.
Experimental: Treatment E	Biological: PF-04950615 (RN316) Intravenous 10mg/mL based on weight 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.

Outcome Measures

Primary Outcome Measures

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

Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <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]
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, SAEs 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 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 [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 [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) [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.

Other Outcome Measures

Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Orange County Research Center	Tustin	California	United States	92780
2	Diablo Clinical Research, Inc.	Walnut Creek	California	United States	94598
3	Innovative Research of West Florida, Inc.	Clearwater	Florida	United States	33756
4	Avail Clinical Research, LLC	DeLand	Florida	United States	32720
5	In Vivo Clinical Research, Inc.	Doral	Florida	United States	33166
6	Jacksonville Center for Clinical Research	Jacksonville	Florida	United States	32216
7	Kendall South Medical Center	Miami	Florida	United States	33185
8	North Georgia Clinical Research	Woodstock	Georgia	United States	30189
9	North Georgia Internal Medicine	Woodstock	Georgia	United States	30189
10	Vince and Associates Clinical Research	Overland Park	Kansas	United States	66212
11	Heartland Research Associates, LLC	Wichita	Kansas	United States	67207
12	L-MARC Research Center	Louisville	Kentucky	United States	40213
13	Commonwealth Biomedical Research, LLC	Madisonville	Kentucky	United States	42431
14	Maine Research Associates	Auburn	Maine	United States	04210
15	Infinity Medical Research	North Dartmouth	Massachusetts	United States	02747
16	Saint Luke's Hospital	Kansas City	Missouri	United States	64111
17	Saint Luke's Lipid and Diabetes Research Center	Kansas City	Missouri	United States	64111
18	The Center for Pharmaceutical Research, P.C.	Kansas City	Missouri	United States	64114
19	Medex Healthcare Research, Inc.	Saint Louis	Missouri	United States	63117
20	New Mexico Clinical Research & Osteoporosis Center, Incorporated	Albuquerque	New Mexico	United States	87106
21	North Carolina Clinical Research	Raleigh	North Carolina	United States	27607
22	PMG Research of Salisbury	Salisbury	North Carolina	United States	28144
23	Lynn Health Science Institute	Oklahoma City	Oklahoma	United States	73112
24	Oklahoma Cardiovascular Research Group (OCRG)	Oklahoma City	Oklahoma	United States	73120
25	Oklahoma Heart Hospital Physicians	Oklahoma City	Oklahoma	United States	73120
26	Oklahoma Heart Hospital	Oklahoma City	Oklahoma	United States	73120
27	Altoona Center for Clinical Research	Duncansville	Pennsylvania	United States	16635
28	Perelman Center for Advanced Medicine	Philadelphia	Pennsylvania	United States	19104
29	Translational Research Center	Philadelphia	Pennsylvania	United States	19104
30	Spartanburg Medical Research	Spartanburg	South Carolina	United States	29303
31	New Orleans Center for Clinical Research	Knoxville	Tennessee	United States	37920
32	Volunteer Research Group	Knoxville	Tennessee	United States	37920
33	Texas Center for Drug Development, Inc.	Houston	Texas	United States	77081
34	Paragon Research Center, LLC	San Antonio	Texas	United States	78205
35	Clinical Trials of Texas, Inc.	San Antonio	Texas	United States	78229
36	San Antonio Preventive & Diagnostic Medicine, PA	San Antonio	Texas	United States	78229
37	National Clinical Research - Norfolk, Inc.	Norfolk	Virginia	United States	23502
38	National Clinical Research - Richmond, Inc.	Richmond	Virginia	United States	23294
39	The Medical Arts Health Research Group	Kelowna	British Columbia	Canada	V1Y 3G8
40	Q & T Research Chicoutimi	Chicoutimi	Quebec	Canada	G7H 7Y8
41	Centre de Recherche Clinique de Laval	Laval	Quebec	Canada	H7T 2P5
42	Diex Research Montreal Inc.	Montreal	Quebec	Canada	H4N 3C5
43	Diex Research Sherbrooke Inc.	Sherbrooke	Quebec	Canada	J1H 1Z1
44	Clinique des Maladies Lipidiques de Quebec Inc.	Quebec		Canada	G1V 4M6

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

To obtain contact information for a study center near you, click here.

Publications

None provided.

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT01342211

Other Study ID Numbers:

B1481005

First Posted:

Apr 27, 2011

Last Update Posted:

Oct 11, 2017

Last Verified:

Sep 1, 2017

Keywords provided by Pfizer

PF-04950615

RN316

Additional relevant MeSH terms:

Hypercholesterolemia

Dyslipidemias

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Bococizumab

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail

Arm/Group Title	Placebo	PF-04950615 0.25 mg/kg	PF-04950615 1.0 mg/kg	PF-04950615 3.0 mg/kg	PF-04950615 6.0 mg/kg
Arm/Group Description	Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram [mg]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
Period Title: Overall Study
STARTED	19	19	18	19	18
Treated	19	17	18	19	17
COMPLETED	19	17	18	17	16
NOT COMPLETED	0	2	0	2	2

Baseline Characteristics

Arm/Group Title	Placebo	PF-04950615 0.25 mg/kg	PF-04950615 1.0 mg/kg	PF-04950615 3.0 mg/kg	PF-04950615 6.0 mg/kg	Total
Arm/Group Description	Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram [mg]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Total of all reporting groups
Overall Participants	19	17	18	19	17	90
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.2 (12.4)	57.9 (10.3)	56.3 (9.1)	58.0 (10.6)	60.8 (5.7)	58.4 (9.9)
Sex: Female, Male (Count of Participants)
Female	6 31.6%	9 52.9%	11 61.1%	11 57.9%	8 47.1%	45 50%
Male	13 68.4%	8 47.1%	7 38.9%	8 42.1%	9 52.9%	45 50%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description
Efficacy analysis set included all participants who received at least 1 dose of study drug and completed the Day 85 visit or dropped out prematurely, whichever was earlier. Here 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.

Arm/Group Title	Placebo	PF-04950615 0.25 mg/kg	PF-04950615 1.0 mg/kg	PF-04950615 3.0 mg/kg	PF-04950615 6.0 mg/kg
Arm/Group Description	Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram [mg]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
Measure Participants	18	16	18	18	17
Mean (Standard Deviation) [percent change]	-8.91 (20.075)	-13.11 (20.786)	-8.63 (30.394)	-47.20 (31.021)	-56.48 (35.289)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 0.25 mg/kg
	Comments	Analysis was performed using analysis of covariance (ANCOVA) model with fixed effects for treatment, background statin, treatment by background statin interaction, and baseline.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.5661
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Least squares (LS) Mean Difference
	Estimated Value	-5.63
	Confidence Interval	(2-Sided) 95% -25.09 to 13.83
	Parameter Dispersion	Type: Standard Error of the Mean Value: 9.759
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 1.0 mg/kg
	Comments	Analysis was performed using ANCOVA model with fixed effects for treatment, background statin, treatment by background statin interaction, and baseline.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.8080
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-2.30
	Confidence Interval	(2-Sided) 95% -21.08 to 16.49
	Parameter Dispersion	Type: Standard Error of the Mean Value: 9.422
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 3.0 mg/kg
	Comments	Analysis was performed using ANCOVA model with fixed effects for treatment, background statin, treatment by background statin interaction, and baseline.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-37.72
	Confidence Interval	(2-Sided) 95% -56.47 to -18.97
	Parameter Dispersion	Type: Standard Error of the Mean Value: 9.404
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 6.0 mg/kg
	Comments	Analysis was performed using ANCOVA model with fixed effects for treatment, background statin, treatment by background statin interaction, and baseline.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-49.11
	Confidence Interval	(2-Sided) 95% -68.08 to -30.14
	Parameter Dispersion	Type: Standard Error of the Mean Value: 9.514
	Estimation Comments

2. Secondary Outcome

Title	Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL)
Description
Time Frame	Day 29, 57, 85

Outcome Measure Data

Analysis Population Description
Efficacy analysis set included all participants who received at least 1 dose of study drug and completed the Day 85 visit or dropped out prematurely, whichever was earlier. 'N' = participants who were evaluable for this outcome measure and 'number analyzed' = participants who were evaluable at specified time points for each arm.

Arm/Group Title	Placebo	PF-04950615 0.25 mg/kg	PF-04950615 1.0 mg/kg	PF-04950615 3.0 mg/kg	PF-04950615 6.0 mg/kg
Arm/Group Description	Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram [mg]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
Measure Participants	19	16	18	18	17
Day 29 <70 mg/dL	5.3 27.9%	6.3 37.1%	11.8 65.6%	77.8 409.5%	100 588.2%
Day 29 <100 mg/dL	47.4 249.5%	18.8 110.6%	35.3 196.1%	94.4 496.8%	100 588.2%
Day 57 <70 mg/dL	0 0%	0 0%	0 0%	44.4 233.7%	76.5 450%
Day 57 <100 mg/dL	47.1 247.9%	13.3 78.2%	53.3 296.1%	66.7 351.1%	88.2 518.8%
Day 85 <70 mg/dL	5.6 29.5%	0 0%	11.1 61.7%	66.7 351.1%	64.7 380.6%
Day 85 <100 mg/dL	33.3 175.3%	50.0 294.1%	33.3 185%	88.9 467.9%	76.5 450%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 0.25 mg/kg
	Comments	Day 29, <70 mg/dL: The standard logistic regression model was used to assess treatment effect.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.8998
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.172
	Confidence Interval	(2-Sided) 95% 0.10 to 13.92
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 1.0 mg/kg
	Comments	Day 29, <70 mg/dL: The standard logistic regression model was used to assess treatment effect.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.5273
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.063
	Confidence Interval	(2-Sided) 95% 0.22 to 19.48
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 3.0 mg/kg
	Comments	Day 29, <70 mg/dL: The standard logistic regression model was used to assess treatment effect.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0004
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	53.924
	Confidence Interval	(2-Sided) 95% 5.93 to 490.67
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 6.0 mg/kg
	Comments	Day 29, <70 mg/dL: The standard logistic regression model was used to assess treatment effect.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	280.366
	Confidence Interval	(2-Sided) 95% 18.65 to 4214.35
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 0.25 mg/kg
	Comments	Day 29, <100 mg/dL: The standard logistic regression model was used to assess treatment effect.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0860
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.262
	Confidence Interval	(2-Sided) 95% 0.06 to 1.21
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 1.0 mg/kg
	Comments	Day 29, <100 mg/dL: The standard logistic regression model was used to assess treatment effect.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.4308
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.579
	Confidence Interval	(2-Sided) 95% 0.15 to 2.25
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 3.0 mg/kg
	Comments	Day 29, <100 mg/dL: The standard logistic regression model was used to assess treatment effect.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0127
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	8.272
	Confidence Interval	(2-Sided) 95% 1.57 to 43.56
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 6.0 mg/kg
	Comments	Day 29, <100 mg/dL: The standard logistic regression model was used to assess treatment effect.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0096
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	13.528
	Confidence Interval	(2-Sided) 95% 1.89 to 97.00
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 0.25 mg/kg
	Comments	Day 57, <70 mg/dL: The standard logistic regression model was used to assess treatment effect.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.9519
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.131
	Confidence Interval	(2-Sided) 95% 0.02 to 61.54
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 1.0 mg/kg
	Comments	Day 57, <70 mg/dL: The standard logistic regression model was used to assess treatment effect.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.9740
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.069
	Confidence Interval	(2-Sided) 95% 0.02 to 58.00
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 3.0 mg/kg
	Comments	Day 57, <70 mg/dL: The standard logistic regression model was used to assess treatment effect.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0273
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	28.286
	Confidence Interval	(2-Sided) 95% 1.46 to 549.78
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 6.0 mg/kg
	Comments	Day 57, <70 mg/dL: The standard logistic regression model was used to assess treatment effect.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0022
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	114.508
	Confidence Interval	(2-Sided) 95% 5.50 to 2384.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 0.25 mg/kg
	Comments	Day 57, <100 mg/dL: The standard logistic regression model was used to assess treatment effect.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0684
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.216
	Confidence Interval	(2-Sided) 95% 0.04 to 1.12
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 1.0 mg/kg
	Comments	Day 57, <100 mg/dL: The standard logistic regression model was used to assess treatment effect.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.9068
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.081
	Confidence Interval	(2-Sided) 95% 0.29 to 3.99
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 3.0 mg/kg
	Comments	Day 57, <100 mg/dL: The standard logistic regression model was used to assess treatment effect.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.2235
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.251
	Confidence Interval	(2-Sided) 95% 0.61 to 8.31
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 6.0 mg/kg
	Comments	Day 57, <100 mg/dL: The standard logistic regression model was used to assess treatment effect.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0120
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	8.250
	Confidence Interval	(2-Sided) 95% 1.59 to 42.82
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 0.25 mg/kg
	Comments	Day 85, <70 mg/dL: The standard logistic regression model was used to assess treatment effect.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.5449
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.359
	Confidence Interval	(2-Sided) 95% 0.01 to 9.92
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 1.0 mg/kg
	Comments	Day 85, <70 mg/dL: The standard logistic regression model was used to assess treatment effect.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.5585
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.914
	Confidence Interval	(2-Sided) 95% 0.22 to 16.85
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 3.0 mg/kg
	Comments	Day 85, <70 mg/dL: The standard logistic regression model was used to assess treatment effect.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0022
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	21.059
	Confidence Interval	(2-Sided) 95% 3.00 to 147.65
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 6.0 mg/kg
	Comments	Day 85, <70 mg/dL: The standard logistic regression model was used to assess treatment effect.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0020
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	22.851
	Confidence Interval	(2-Sided) 95% 3.15 to 165.99
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 0.25 mg/kg
	Comments	Day 85, <100 mg/dL: The standard logistic regression model was used to assess treatment effect.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.3750
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.844
	Confidence Interval	(2-Sided) 95% 0.48 to 7.12
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 1.0 mg/kg
	Comments	Day 85, <100 mg/dL: The standard logistic regression model was used to assess treatment effect.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.9140
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.078
	Confidence Interval	(2-Sided) 95% 0.28 to 4.23
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 3.0 mg/kg
	Comments	Day 85, <100 mg/dL: The standard logistic regression model was used to assess treatment effect.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0036
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	9.548
	Confidence Interval	(2-Sided) 95% 2.09 to 43.57
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 6.0 mg/kg
	Comments	Day 85, <100 mg/dL: The standard logistic regression model was used to assess treatment effect.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0149
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	6.093
	Confidence Interval	(2-Sided) 95% 1.42 to 26.10
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C)
Description
Time Frame	Day 29, 57, 85

Outcome Measure Data

Analysis Population Description
Efficacy analysis set included all participants who received at least 1 dose of study drug and completed the Day 85 visit or dropped out prematurely, whichever was earlier. 'N' = participants who were evaluable for this outcome measure and 'number analyzed' = participants who were evaluable at specified time points for each arm.

Arm/Group Title	Placebo	PF-04950615 0.25 mg/kg	PF-04950615 1.0 mg/kg	PF-04950615 3.0 mg/kg	PF-04950615 6.0 mg/kg
Arm/Group Description	Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram [mg]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
Measure Participants	19	16	18	18	17
Day 29	15.8 83.2%	25.0 147.1%	11.8 65.6%	88.9 467.9%	100 588.2%
Day 57	11.8 62.1%	0 0%	26.7 148.3%	55.6 292.6%	76.5 450%
Day 85	16.7 87.9%	18.8 110.6%	22.2 123.3%	66.7 351.1%	82.4 484.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 0.25 mg/kg
	Comments	Day 29: The standard logistic regression model was used to assess treatment effect.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.5436
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.674
	Confidence Interval	(2-Sided) 95% 0.32 to 8.83
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 1.0 mg/kg
	Comments	Day 29: The standard logistic regression model was used to assess treatment effect.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.7420
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.734
	Confidence Interval	(2-Sided) 95% 0.12 to 4.63
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 3.0 mg/kg
	Comments	Day 29: The standard logistic regression model was used to assess treatment effect.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0002
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	28.151
	Confidence Interval	(2-Sided) 95% 4.73 to 167.62
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 6.0 mg/kg
	Comments	Day 29: The standard logistic regression model was used to assess treatment effect.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	71.214
	Confidence Interval	(2-Sided) 95% 7.88 to 643.42
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 0.25 mg/kg
	Comments	Day 57: The standard logistic regression model was used to assess treatment effect.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.3210
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.203
	Confidence Interval	(2-Sided) 95% 0.01 to 4.74
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 1.0 mg/kg
	Comments	Day 57: The standard logistic regression model was used to assess treatment effect.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.3786
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.175
	Confidence Interval	(2-Sided) 95% 0.39 to 12.27
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 3.0 mg/kg
	Comments	Day 57: The standard logistic regression model was used to assess treatment effect.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0144
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	7.576
	Confidence Interval	(2-Sided) 95% 1.50 to 38.38
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 6.0 mg/kg
	Comments	Day 57: The standard logistic regression model was used to assess treatment effect.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0007
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	20.465
	Confidence Interval	(2-Sided) 95% 3.59 to 116.60
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 0.25 mg/kg
	Comments	Day 85: The standard logistic regression model was used to assess treatment effect.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.8626
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.161
	Confidence Interval	(2-Sided) 95% 0.21 to 6.30
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 1.0 mg/kg
	Comments	Day 85: The standard logistic regression model was used to assess treatment effect.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.6237
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.497
	Confidence Interval	(2-Sided) 95% 0.30 to 7.51
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 3.0 mg/kg
	Comments	Day 85: The standard logistic regression model was used to assess treatment effect.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0072
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	8.029
	Confidence Interval	(2-Sided) 95% 1.76 to 36.65
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-04950615 6.0 mg/kg
	Comments	Day 85: The standard logistic regression model was used to assess treatment effect.
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.0005
	Comments
	Method	Regression, Logistic
	Comments

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	20.557
	Confidence Interval	(2-Sided) 95% 3.73 to 113.20
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Description	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.
Time Frame	Baseline, Day 29, 57, 85

Outcome Measure Data

Analysis Population Description
Efficacy analysis set. 'number analyzed' = participants who were evaluable at specified time points for each arm. Results for change at Day 85 in lipid parameters ApoB and ApoA1 were not reported because data was not collected for ApoB and ApoA1 at Day 85 due to an inadvertent omission in the protocol.

Arm/Group Title	Placebo	PF-04950615 0.25 mg/kg	PF-04950615 1.0 mg/kg	PF-04950615 3.0 mg/kg	PF-04950615 6.0 mg/kg
Arm/Group Description	Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram [mg]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
Measure Participants	19	17	18	19	17
Baseline: HDL-C	46.18 (10.235)	51.53 (14.084)	49.11 (13.291)	50.24 (11.724)	44.76 (8.189)
Baseline: TC	202.82 (27.96)	202.03 (27.10)	205.11 (22.64)	202.66 (37.98)	206.91 (35.96)
Baseline: Non-HDL-C	156.63 (30.61)	150.50 (29.03)	156.00 (24.08)	152.42 (38.89)	162.15 (37.82)
Baseline: TG	136.18 (58.82)	137.62 (87.56)	162.83 (85.68)	118.05 (47.08)	172.47 (86.49)
Baseline: ApoB	106.74 (19.86)	105.76 (18.21)	109.83 (23.61)	102.84 (22.06)	109.06 (29.49)
Baseline: ApoA1	140.32 (21.71)	153.76 (22.73)	146.44 (20.35)	143.11 (20.31)	141.29 (16.25)
Change at Day 29: HDL-C	0.87 (5.627)	3.59 (7.265)	0.79 (5.041)	4.50 (4.624)	6.00 (6.072)
Change at Day 29:TC	-10.66 (31.13)	-9.97 (29.104)	-21.94 (15.93)	-81.00 (49.61)	-111.68 (28.7)
Change at Day 29: Non-HDL-C	-11.53 (33.16)	-13.56 (28.17)	-22.74 (14.91)	-85.50 (48.59)	-117.68 (25.9)
Change at Day 29: TG	8.66 (46.865)	-3.72 (31.384)	-37.03 (66.12)	-18.97 (48.88)	-46.94 (65.20)
Change at Day 29: ApoB	-5.05 (16.119)	-9.56 (18.155)	-13.24 (15.63)	-47.13 (23.85)	-67.40 (22.03)
Change at Day 29: ApoA1	1.68 (10.546)	2.06 (17.117)	4.29 (11.751)	11.67 (14.892)	7.29 (12.875)
Change at Day 57: HDL-C	-0.74 (5.310)	2.23 (8.113)	2.83 (8.004)	3.17 (7.462)	4.88 (7.167)
Change at Day 57: TC	-13.97 (28.37)	-5.67 (18.777)	-8.20 (39.052)	-51.33 (52.08)	-79.21 (52.81)
Change at Day 57: Non-HDL-C	-13.24 (29.52)	-7.90 (21.123)	-11.03 (39.49)	-54.50 (55.71)	-84.09 (54.92)
Change at Day 57: TG	-1.24 (61.405)	-11.37 (36.99)	-15.73 (95.34)	-4.47 (74.402)	-26.71 (49.54)
Change at Day 57: ApoB	-8.94 (14.355)	-1.07 (12.384)	-3.87 (27.302)	-29.07 (31.83)	-45.90 (36.60)
Change at Day 57: ApoA1	-2.59 (15.500)	-0.13 (14.020)	8.47 (18.917)	8.39 (20.448)	10.12 (14.168)
Change at Day 85: HDL-C	0.08 (5.219)	1.81 (9.377)	1.44 (5.739)	5.50 (7.310)	4.82 (7.671)
Change at Day 85: TC	-10.97 (24.41)	-20.56 (31.99)	-11.56 (43.45)	-62.89 (52.73)	-79.97 (55.39)
Change at Day 85: Non-HDL-C	-11.06 (26.14)	-22.38 (34.45)	-13.00 (40.28)	-68.39 (54.01)	-84.79 (52.95)
Change at Day 85: TG	2.97 (59.087)	-25.97 (49.96)	-9.39 (63.159)	-6.58 (58.104)	-40.12 (73.83)

5. Secondary Outcome

Title	Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85
Description	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.
Time Frame	Baseline, Day 29, 57, 85

Outcome Measure Data

Analysis Population Description
Efficacy analysis set. 'number analyzed' = participants who were evaluable at specified time points for each arm. Results for percent change at Day 85 for ApoB and ApoA1 were not reported because data was not collected for ApoB and ApoA1 at Day 85 due to an inadvertent omission in the protocol.

Arm/Group Title	Placebo	PF-04950615 0.25 mg/kg	PF-04950615 1.0 mg/kg	PF-04950615 3.0 mg/kg	PF-04950615 6.0 mg/kg
Arm/Group Description	Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram [mg]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
Measure Participants	19	17	18	19	17
Percent change at Day 29: HDL-C	1.98 (11.164)	5.88 (12.764)	0.27 (9.020)	9.34 (10.291)	12.96 (12.116)
Percent change at Day 29: TC	-5.03 (15.148)	-3.88 (14.148)	-10.62 (7.813)	-38.54 (19.844)	-53.52 (7.450)
Percent change at Day 29:Non-HDL-C	-7.14 (20.758)	-7.57 (17.933)	-14.75 (10.320)	-54.06 (23.588)	-73.23 (9.029)
Percent change at Day 29: TG	9.83 (35.146)	-0.50 (26.358)	-15.79 (27.131)	-15.94 (34.219)	-22.55 (31.973)
Percent change at Day 29: ApoB	-4.09 (14.429)	-7.67 (15.315)	-11.27 (14.177)	-44.93 (18.320)	-61.17 (9.142)
Percent change at Day 29: ApoA1	1.24 (7.493)	1.50 (10.896)	2.88 (7.949)	8.75 (11.114)	5.55 (9.613)
Percent change at Day 57: HDL-C	-1.09 (10.708)	4.96 (17.618)	6.01 (15.077)	6.78 (15.755)	11.06 (15.390)
Percent change at Day 57: TC	-6.91 (13.742)	-2.27 (8.829)	-3.85 (18.857)	-24.17 (22.496)	-37.36 (21.167)
Percent change at Day 57: Non-HDL-C	-8.34 (18.789)	-4.26 (12.999)	-6.97 (23.977)	-34.84 (31.588)	-50.78 (26.254)
Percent change at Day 57: TG	5.90 (42.384)	-2.62 (21.430)	1.66 (53.893)	-5.70 (53.271)	-10.76 (32.710)
Percent change at Day 57: ApoB	-8.32 (13.214)	-0.61 (12.068)	-1.51 (23.582)	-27.25 (28.265)	-40.06 (29.448)
Percent change at Day 57: ApoA1	-1.70 (11.575)	0.57 (9.918)	5.31 (11.150)	6.81 (15.094)	7.81 (12.152)
Percent change at Day 85: HDL-C	0.87 (10.121)	3.58 (19.489)	3.00 (12.481)	10.67 (13.967)	10.70 (17.738)
Percent change at Day 85: TC	-5.44 (12.468)	-9.45 (14.947)	-5.52 (20.658)	-28.78 (22.023)	-36.55 (26.150)
Percent change at Day 85: Non-HDL-C	-6.78 (17.417)	-13.11 (20.428)	-8.48 (24.291)	-41.28 (27.815)	-50.16 (32.255)
Percent change at Day 85: TG	6.16 (42.923)	-8.14 (37.105)	-1.90 (37.939)	-4.22 (42.180)	-14.11 (40.324)

6. Secondary Outcome

Title	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Description	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.
Time Frame	Day 1 up to Day 141

Outcome Measure Data

Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug.

Arm/Group Title	Placebo	PF-04950615 0.25 mg/kg	PF-04950615 1.0 mg/kg	PF-04950615 3.0 mg/kg	PF-04950615 6.0 mg/kg
Arm/Group Description	Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram [mg]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
Measure Participants	19	17	18	19	17
TEAEs	14 73.7%	13 76.5%	13 72.2%	11 57.9%	11 64.7%
TESAEs	0 0%	1 5.9%	1 5.6%	0 0%	0 0%
Treatment related TEAEs	3 15.8%	4 23.5%	2 11.1%	2 10.5%	3 17.6%

7. Secondary Outcome

Title	Number of Treatment-Emergent Adverse Events (TEAEs) by Severity
Description	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.
Time Frame	Day 1 up to Day 141

Outcome Measure Data

Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug.

Arm/Group Title	Placebo	PF-04950615 0.25 mg/kg	PF-04950615 1.0 mg/kg	PF-04950615 3.0 mg/kg	PF-04950615 6.0 mg/kg
Arm/Group Description	Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram [mg]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
Measure Participants	19	17	18	19	17
Mild	24	18	30	18	17
Moderate	2	16	13	12	10
Severe	0	1	1	0	0

8. Secondary Outcome

Title	Number of Participants With Clinically Relevant Laboratory Abnormalities
Description	Hematology (hemoglobin[hgb],hematocrit,red blood cell[RBC]<0.8lower limit of normal[LLN],mean cell[MC] volume,MC hgb,MC hg concentration <0.9LLN, greater than[>] 1.1upper limit of normal[ULN], platelet <0.5LLN,>1.75ULN, white blood cell[WBC]<0.6LLN,>1.5ULN,neutrophil,lymphocyte <0.8LLN,>1.2ULN,eosinophil,basophil,monocyte >1.2ULN);chemistry(total, direct, indirect bilirubin[BR]>1.5ULN,aspartate aminotransferase[AT],alanine AT,alkaline phosphatase,gamma-glutyl transferase>3.0ULN,protein,lactate dehydrogenase <0.8LLN,>1.2ULN,creatinine,blood urea nitrogen>1.3ULN,uric acid >1.2ULN,potassium,chloride,calcium,bicarbonate<0.9LLN,>1.1ULN, sodium<0.95LLN,>1.05ULN,glucose[GL]<0.6LLN,>1.5ULN,amylase,lipase >1.5ULN,creatinine kinase>2.0ULN);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).
Time Frame	Day 1 up to Day 141

Outcome Measure Data

Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug. Here 'N' signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Placebo	PF-04950615 0.25 mg/kg	PF-04950615 1.0 mg/kg	PF-04950615 3.0 mg/kg	PF-04950615 6.0 mg/kg
Arm/Group Description	Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram [mg]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
Measure Participants	19	17	18	18	17
Number [participants]	18 94.7%	15 88.2%	17 94.4%	18 94.7%	14 82.4%

9. Secondary Outcome

Title	Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters
Description	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).
Time Frame	Day 1 up to Day 141

Outcome Measure Data

Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug.

Arm/Group Title	Placebo	PF-04950615 0.25 mg/kg	PF-04950615 1.0 mg/kg	PF-04950615 3.0 mg/kg	PF-04950615 6.0 mg/kg
Arm/Group Description	Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram [mg]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
Measure Participants	19	17	18	19	17
Supine systolic BP: Maximum increase >=30mmHg	2 10.5%	4 23.5%	3 16.7%	3 15.8%	0 0%
Supine diastolic BP: Maximum increase >=20mmHg	2 10.5%	2 11.8%	2 11.1%	2 10.5%	0 0%
Supine systolic BP: Maximum decrease >=30mmHg	1 5.3%	3 17.6%	0 0%	2 10.5%	3 17.6%
Supine diastolic BP: Maximum decrease >=20mmHg	1 5.3%	4 23.5%	1 5.6%	4 21.1%	2 11.8%
PR interval: >=25/50% increase	0 0%	0 0%	0 0%	0 0%	0 0%
QRS interval: >=25/50% increase	0 0%	0 0%	0 0%	0 0%	0 0%
QTCF: Maximum increase >30 to <=60 msec	1 5.3%	3 17.6%	3 16.7%	1 5.3%	2 11.8%
QTCF: Maximum increase >60 msec	0 0%	0 0%	0 0%	0 0%	0 0%

10. Secondary Outcome

Title	Number of Participants With Anti-drug Antibody (ADA)
Description	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.
Time Frame	Day 1 up to Day 141

Outcome Measure Data

Analysis Population Description
Analysis set included all participants who received at least 1 dose of PF-04950615 (RN316).

Arm/Group Title	PF-04950615 0.25 mg/kg	PF-04950615 1.0 mg/kg	PF-04950615 3.0 mg/kg	PF-04950615 6.0 mg/kg
Arm/Group Description	Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
Measure Participants	17	18	19	17
Number [participants]	0 0%	3 17.6%	1 5.6%	1 5.3%

11. Other Pre-specified Outcome

Title	Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141
Description	Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.
Time Frame	Baseline, Day 29, 57, 71, 85, 99, 127, 141

Outcome Measure Data

Analysis Population Description
Efficacy analysis set. 'number analyzed' = participants who were evaluable for specified time points for each arm. Results for change at Day 85 in Lp(a) was not reported because data was not collected for Lp(a) at Day 85 due to an inadvertent omission in the protocol.

Arm/Group Title	Placebo	PF-04950615 0.25 mg/kg	PF-04950615 1.0 mg/kg	PF-04950615 3.0 mg/kg	PF-04950615 6.0 mg/kg
Arm/Group Description	Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram [mg]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
Measure Participants	19	17	18	19	17
Baseline	37.46 (34.809)	61.05 (50.109)	63.66 (50.594)	66.29 (79.992)	59.73 (72.611)
Change at Day 29	3.30 (9.837)	2.49 (17.630)	2.79 (21.729)	-5.42 (17.801)	-14.08 (15.693)
Change at Day 57	1.50 (11.677)	-2.11 (7.274)	0.86 (22.192)	-3.44 (19.032)	-11.70 (23.474)
Change at Day 71	1.27 (13.458)	-0.84 (10.351)	-9.26 (24.021)	-4.57 (16.857)	-15.45 (34.324)
Change at Day 99	2.22 (14.847)	4.71 (15.625)	-1.70 (10.730)	4.89 (24.930)	-17.52 (37.185)
Change at Day 127	-3.25 (28.197)	2.11 (11.218)	-0.59 (19.654)	-6.45 (37.106)	-8.11 (31.751)
Change at Day 141	2.48 (13.753)	-0.72 (15.353)	0.84 (12.110)	3.93 (14.947)	-5.52 (36.935)

12. Other Pre-specified Outcome

Title	Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141
Description	Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.
Time Frame	Baseline, Day 29, 57, 71, 85, 99, 127, 141

Outcome Measure Data

Analysis Population Description
Efficacy analysis set. 'number analyzed' = participants who were evaluable for specified time points for each arm. Results for percent change at Day 85 in Lp(a) was not reported because data was not collected for Lp(a) at Day 85 due to an inadvertent omission in the protocol.

Arm/Group Title	Placebo	PF-04950615 0.25 mg/kg	PF-04950615 1.0 mg/kg	PF-04950615 3.0 mg/kg	PF-04950615 6.0 mg/kg
Arm/Group Description	Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram [mg]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.	Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
Measure Participants	19	17	18	19	17
Percent change at Day 29	11.56 (25.846)	14.10 (42.815)	4.23 (22.161)	-21.34 (25.694)	-29.90 (22.427)
Percent change at Day 57	5.13 (20.258)	-0.02 (14.398)	1.38 (21.771)	-10.60 (22.427)	-23.43 (27.739)
Percent change at Day 71	-3.14 (27.897)	-3.43 (14.579)	-21.42 (26.676)	-18.77 (23.309)	-25.95 (29.676)
Percent change at Day 99	0.20 (23.623)	2.66 (19.043)	-3.46 (19.600)	-6.58 (5.693)	-25.39 (22.064)
Percent change at Day 127	-0.08 (42.026)	1.84 (15.518)	-0.14 (28.160)	-11.44 (31.828)	-12.93 (27.915)
Percent change at Day 141	7.37 (28.842)	-2.41 (20.150)	-1.27 (19.554)	0.50 (22.445)	-2.41 (31.080)

Adverse Events

	Placebo		PF-04950615 0.25 mg/kg		PF-04950615 1.0 mg/kg		PF-04950615 3.0 mg/kg		PF-04950615 6.0 mg/kg
Time Frame
Adverse Event Reporting Description	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.

Arm/Group Title	Placebo		PF-04950615 0.25 mg/kg		PF-04950615 1.0 mg/kg		PF-04950615 3.0 mg/kg		PF-04950615 6.0 mg/kg
Arm/Group Description	Participants received intravenous infusion of placebo (normal saline) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 milligram [mg]) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.		Participants received intravenous infusion of PF-04950615 (RN316) 0.25 milligram per kilogram (mg/kg) on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.		Participants received intravenous infusion of PF-04950615 (RN316) 1.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.		Participants received intravenous infusion of PF-04950615 (RN316) 3.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.		Participants received intravenous infusion of PF-04950615 (RN316) 6.0 mg/kg on Day 1, 29 and 57 along with atorvastatin or simvastatin (40 or 80 mg) or rosuvastatin (20 or 40 mg) tablet orally once daily from Day 1 to 141.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		PF-04950615 0.25 mg/kg		PF-04950615 1.0 mg/kg		PF-04950615 3.0 mg/kg		PF-04950615 6.0 mg/kg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		1/17 (5.9%)		1/18 (5.6%)		0/19 (0%)		0/17 (0%)
Gastrointestinal disorders
Abdominal pain lower	0/19 (0%)		0/17 (0%)		1/18 (5.6%)		0/19 (0%)		0/17 (0%)
Psychiatric disorders
Depression	0/19 (0%)		1/17 (5.9%)		0/18 (0%)		0/19 (0%)		0/17 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		PF-04950615 0.25 mg/kg		PF-04950615 1.0 mg/kg		PF-04950615 3.0 mg/kg		PF-04950615 6.0 mg/kg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/19 (73.7%)		13/17 (76.5%)		13/18 (72.2%)		11/19 (57.9%)		11/17 (64.7%)
Blood and lymphatic system disorders
Anaemia	0/19 (0%)		0/17 (0%)		1/18 (5.6%)		0/19 (0%)		0/17 (0%)
Cardiac disorders
Sinus arrest	1/19 (5.3%)		0/17 (0%)		0/18 (0%)		0/19 (0%)		0/17 (0%)
Supraventricular extrasystoles	0/19 (0%)		0/17 (0%)		0/18 (0%)		0/19 (0%)		1/17 (5.9%)
Ventricular extrasystoles	1/19 (5.3%)		0/17 (0%)		0/18 (0%)		0/19 (0%)		0/17 (0%)
Ear and labyrinth disorders
Ear disorder	0/19 (0%)		0/17 (0%)		0/18 (0%)		1/19 (5.3%)		0/17 (0%)
Ear pain	0/19 (0%)		0/17 (0%)		1/18 (5.6%)		0/19 (0%)		0/17 (0%)
Gastrointestinal disorders
Abdominal pain	0/19 (0%)		1/17 (5.9%)		0/18 (0%)		1/19 (5.3%)		1/17 (5.9%)
Abdominal pain upper	0/19 (0%)		0/17 (0%)		0/18 (0%)		1/19 (5.3%)		1/17 (5.9%)
Constipation	0/19 (0%)		0/17 (0%)		0/18 (0%)		1/19 (5.3%)		0/17 (0%)
Diarrhoea	1/19 (5.3%)		0/17 (0%)		1/18 (5.6%)		0/19 (0%)		0/17 (0%)
Dyspepsia	0/19 (0%)		0/17 (0%)		0/18 (0%)		1/19 (5.3%)		0/17 (0%)
Flatulence	0/19 (0%)		0/17 (0%)		0/18 (0%)		1/19 (5.3%)		2/17 (11.8%)
Gastrooesophageal reflux disease	0/19 (0%)		1/17 (5.9%)		0/18 (0%)		0/19 (0%)		0/17 (0%)
Hypoaesthesia oral	1/19 (5.3%)		0/17 (0%)		0/18 (0%)		0/19 (0%)		0/17 (0%)
Lip dry	1/19 (5.3%)		0/17 (0%)		0/18 (0%)		0/19 (0%)		0/17 (0%)
Nausea	1/19 (5.3%)		1/17 (5.9%)		0/18 (0%)		1/19 (5.3%)		0/17 (0%)
Polyp colorectal	1/19 (5.3%)		0/17 (0%)		0/18 (0%)		0/19 (0%)		0/17 (0%)
Salivary hypersecretion	1/19 (5.3%)		0/17 (0%)		0/18 (0%)		0/19 (0%)		0/17 (0%)
Vomiting	0/19 (0%)		2/17 (11.8%)		0/18 (0%)		0/19 (0%)		0/17 (0%)
General disorders
Axillary pain	0/19 (0%)		1/17 (5.9%)		0/18 (0%)		0/19 (0%)		0/17 (0%)
Fatigue	0/19 (0%)		0/17 (0%)		0/18 (0%)		1/19 (5.3%)		1/17 (5.9%)
Influenza like illness	0/19 (0%)		1/17 (5.9%)		0/18 (0%)		0/19 (0%)		0/17 (0%)
Infusion site phlebitis	0/19 (0%)		0/17 (0%)		0/18 (0%)		1/19 (5.3%)		0/17 (0%)
Non-cardiac chest pain	0/19 (0%)		1/17 (5.9%)		0/18 (0%)		0/19 (0%)		0/17 (0%)
Oedema peripheral	0/19 (0%)		1/17 (5.9%)		2/18 (11.1%)		0/19 (0%)		0/17 (0%)
Pyrexia	0/19 (0%)		0/17 (0%)		0/18 (0%)		1/19 (5.3%)		0/17 (0%)
Infections and infestations
Acute sinusitis	0/19 (0%)		0/17 (0%)		1/18 (5.6%)		0/19 (0%)		0/17 (0%)
Fungal skin infection	0/19 (0%)		0/17 (0%)		0/18 (0%)		0/19 (0%)		2/17 (11.8%)
Influenza	0/19 (0%)		0/17 (0%)		0/18 (0%)		0/19 (0%)		1/17 (5.9%)
Nasopharyngitis	1/19 (5.3%)		1/17 (5.9%)		1/18 (5.6%)		1/19 (5.3%)		0/17 (0%)
Oral herpes	0/19 (0%)		1/17 (5.9%)		0/18 (0%)		0/19 (0%)		0/17 (0%)
Sinusitis	0/19 (0%)		1/17 (5.9%)		2/18 (11.1%)		0/19 (0%)		0/17 (0%)
Tooth abscess	0/19 (0%)		1/17 (5.9%)		0/18 (0%)		0/19 (0%)		0/17 (0%)
Upper respiratory tract infection	2/19 (10.5%)		0/17 (0%)		4/18 (22.2%)		3/19 (15.8%)		0/17 (0%)
Urinary tract infection	1/19 (5.3%)		0/17 (0%)		0/18 (0%)		2/19 (10.5%)		0/17 (0%)
Viral infection	0/19 (0%)		0/17 (0%)		0/18 (0%)		1/19 (5.3%)		0/17 (0%)
Viral upper respiratory tract infection	0/19 (0%)		0/17 (0%)		1/18 (5.6%)		0/19 (0%)		0/17 (0%)
Injury, poisoning and procedural complications
Arthropod bite	1/19 (5.3%)		0/17 (0%)		0/18 (0%)		0/19 (0%)		0/17 (0%)
Contusion	0/19 (0%)		1/17 (5.9%)		0/18 (0%)		0/19 (0%)		0/17 (0%)
Fall	0/19 (0%)		1/17 (5.9%)		0/18 (0%)		0/19 (0%)		0/17 (0%)
Joint injury	0/19 (0%)		0/17 (0%)		1/18 (5.6%)		0/19 (0%)		0/17 (0%)
Laceration	0/19 (0%)		0/17 (0%)		0/18 (0%)		1/19 (5.3%)		0/17 (0%)
Muscle strain	1/19 (5.3%)		0/17 (0%)		0/18 (0%)		0/19 (0%)		0/17 (0%)
Procedural pain	0/19 (0%)		1/17 (5.9%)		0/18 (0%)		0/19 (0%)		0/17 (0%)
Tooth fracture	0/19 (0%)		0/17 (0%)		0/18 (0%)		0/19 (0%)		1/17 (5.9%)
Investigations
Alanine aminotransferase increased	0/19 (0%)		0/17 (0%)		1/18 (5.6%)		0/19 (0%)		0/17 (0%)
Amylase increased	0/19 (0%)		0/17 (0%)		1/18 (5.6%)		0/19 (0%)		0/17 (0%)
Bilirubin conjugated increased	0/19 (0%)		0/17 (0%)		1/18 (5.6%)		0/19 (0%)		0/17 (0%)
Blood alkaline phosphatase increased	0/19 (0%)		0/17 (0%)		1/18 (5.6%)		0/19 (0%)		0/17 (0%)
Blood creatine phosphokinase increased	0/19 (0%)		1/17 (5.9%)		0/18 (0%)		0/19 (0%)		0/17 (0%)
Blood glucose increased	0/19 (0%)		0/17 (0%)		1/18 (5.6%)		0/19 (0%)		0/17 (0%)
Blood lactate dehydrogenase increased	0/19 (0%)		0/17 (0%)		1/18 (5.6%)		0/19 (0%)		0/17 (0%)
Blood pressure decreased	0/19 (0%)		1/17 (5.9%)		0/18 (0%)		0/19 (0%)		0/17 (0%)
Blood pressure increased	0/19 (0%)		1/17 (5.9%)		0/18 (0%)		1/19 (5.3%)		0/17 (0%)
Gamma-glutamyltransferase increased	0/19 (0%)		0/17 (0%)		1/18 (5.6%)		0/19 (0%)		1/17 (5.9%)
Lipase increased	0/19 (0%)		0/17 (0%)		1/18 (5.6%)		0/19 (0%)		0/17 (0%)
Occult blood positive	0/19 (0%)		1/17 (5.9%)		0/18 (0%)		0/19 (0%)		0/17 (0%)
Metabolism and nutrition disorders
Hyperglycaemia	0/19 (0%)		0/17 (0%)		1/18 (5.6%)		0/19 (0%)		0/17 (0%)
Increased appetite	0/19 (0%)		0/17 (0%)		0/18 (0%)		1/19 (5.3%)		0/17 (0%)
Type 2 diabetes mellitus	0/19 (0%)		0/17 (0%)		0/18 (0%)		0/19 (0%)		1/17 (5.9%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/19 (0%)		0/17 (0%)		1/18 (5.6%)		2/19 (10.5%)		3/17 (17.6%)
Arthritis	0/19 (0%)		0/17 (0%)		1/18 (5.6%)		0/19 (0%)		0/17 (0%)
Back pain	1/19 (5.3%)		1/17 (5.9%)		2/18 (11.1%)		0/19 (0%)		0/17 (0%)
Muscle spasms	0/19 (0%)		0/17 (0%)		0/18 (0%)		0/19 (0%)		1/17 (5.9%)
Musculoskeletal pain	0/19 (0%)		0/17 (0%)		0/18 (0%)		1/19 (5.3%)		0/17 (0%)
Myalgia	1/19 (5.3%)		2/17 (11.8%)		0/18 (0%)		1/19 (5.3%)		1/17 (5.9%)
Neck pain	1/19 (5.3%)		0/17 (0%)		0/18 (0%)		0/19 (0%)		0/17 (0%)
Pain in extremity	0/19 (0%)		0/17 (0%)		2/18 (11.1%)		0/19 (0%)		1/17 (5.9%)
Pain in jaw	0/19 (0%)		1/17 (5.9%)		0/18 (0%)		0/19 (0%)		0/17 (0%)
Tendonitis	0/19 (0%)		0/17 (0%)		0/18 (0%)		1/19 (5.3%)		0/17 (0%)
Hyporeflexia	0/19 (0%)		0/17 (0%)		0/18 (0%)		1/19 (5.3%)		0/17 (0%)
Migraine	0/19 (0%)		0/17 (0%)		1/18 (5.6%)		0/19 (0%)		0/17 (0%)
Paraesthesia	0/19 (0%)		1/17 (5.9%)		0/18 (0%)		0/19 (0%)		1/17 (5.9%)
Sinus headache	1/19 (5.3%)		0/17 (0%)		0/18 (0%)		0/19 (0%)		0/17 (0%)
Syncope	0/19 (0%)		0/17 (0%)		1/18 (5.6%)		0/19 (0%)		0/17 (0%)
Nervous system disorders
Dizziness	0/19 (0%)		0/17 (0%)		1/18 (5.6%)		0/19 (0%)		0/17 (0%)
Headache	5/19 (26.3%)		3/17 (17.6%)		3/18 (16.7%)		3/19 (15.8%)		1/17 (5.9%)
Hypoaesthesia	0/19 (0%)		0/17 (0%)		1/18 (5.6%)		0/19 (0%)		1/17 (5.9%)
Psychiatric disorders
Insomnia	0/19 (0%)		0/17 (0%)		0/18 (0%)		0/19 (0%)		1/17 (5.9%)
Renal and urinary disorders
Hypertonic bladder	1/19 (5.3%)		0/17 (0%)		0/18 (0%)		0/19 (0%)		0/17 (0%)
Respiratory, thoracic and mediastinal disorders
Asthma	0/19 (0%)		0/17 (0%)		0/18 (0%)		0/19 (0%)		1/17 (5.9%)
Cough	0/19 (0%)		0/17 (0%)		1/18 (5.6%)		0/19 (0%)		0/17 (0%)
Dyspnoea	0/19 (0%)		0/17 (0%)		1/18 (5.6%)		0/19 (0%)		0/17 (0%)
Respiratory tract congestion	0/19 (0%)		0/17 (0%)		1/18 (5.6%)		0/19 (0%)		0/17 (0%)
Rhinitis seasonal	0/19 (0%)		0/17 (0%)		0/18 (0%)		0/19 (0%)		1/17 (5.9%)
Upper-airway cough syndrome	0/19 (0%)		1/17 (5.9%)		0/18 (0%)		0/19 (0%)		1/17 (5.9%)
Skin and subcutaneous tissue disorders
Alopecia	0/19 (0%)		0/17 (0%)		1/18 (5.6%)		0/19 (0%)		0/17 (0%)
Dermatitis	0/19 (0%)		1/17 (5.9%)		0/18 (0%)		0/19 (0%)		0/17 (0%)
Dermatitis contact	0/19 (0%)		0/17 (0%)		0/18 (0%)		0/19 (0%)		1/17 (5.9%)
Ingrowing nail	0/19 (0%)		0/17 (0%)		0/18 (0%)		0/19 (0%)		1/17 (5.9%)
Night sweats	0/19 (0%)		0/17 (0%)		0/18 (0%)		1/19 (5.3%)		0/17 (0%)
Pruritus	0/19 (0%)		0/17 (0%)		2/18 (11.1%)		0/19 (0%)		0/17 (0%)
Urticaria	0/19 (0%)		1/17 (5.9%)		0/18 (0%)		0/19 (0%)		0/17 (0%)
Vascular disorders
Haematoma	1/19 (5.3%)		1/17 (5.9%)		0/18 (0%)		0/19 (0%)		0/17 (0%)
Hypertension	0/19 (0%)		1/17 (5.9%)		0/18 (0%)		0/19 (0%)		0/17 (0%)

Limitations/Caveats

Due to an inadvertent omission in the protocol at Day 85, presented limitations in the assessment of treatment effect on ApoA1, ApoB and Lp(a) for Day 85.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.

Results Point of Contact

Name/Title	Pfizer ClinicalTrials.gov Call Center
Organization	Pfizer, Inc.
Phone	1-800-718-1021
Email	ClinicalTrials.gov_Inquiries@pfizer.com

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT01342211

Other Study ID Numbers:

B1481005

First Posted:

Apr 27, 2011

Last Update Posted:

Oct 11, 2017

Last Verified:

Sep 1, 2017

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

Study Details

Study Description

Brief Summary

Study Design

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

Other Outcome Measures

Eligibility Criteria

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Locations

Sponsors and Collaborators

Investigators

Study Documents (Full-Text)

More Information

Additional Information:

Publications

Study Results

Participant Flow

Baseline Characteristics

Outcome Measures

Outcome Measure Data

Statistical Analysis 1

Statistical Analysis 2

Statistical Analysis 3

Statistical Analysis 4

Outcome Measure Data

Statistical Analysis 1

Statistical Analysis 2

Statistical Analysis 3

Statistical Analysis 4

Statistical Analysis 5

Statistical Analysis 6

Statistical Analysis 7

Statistical Analysis 8

Statistical Analysis 9

Statistical Analysis 10

Statistical Analysis 11

Statistical Analysis 12

Statistical Analysis 13

Statistical Analysis 14

Statistical Analysis 15

Statistical Analysis 16

Statistical Analysis 17

Statistical Analysis 18

Statistical Analysis 19

Statistical Analysis 20

Statistical Analysis 21

Statistical Analysis 22

Statistical Analysis 23

Statistical Analysis 24

Outcome Measure Data

Statistical Analysis 1

Statistical Analysis 2

Statistical Analysis 3

Statistical Analysis 4

Statistical Analysis 5

Statistical Analysis 6

Statistical Analysis 7

Statistical Analysis 8

Statistical Analysis 9

Statistical Analysis 10

Statistical Analysis 11

Statistical Analysis 12

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Adverse Events

All Cause Mortality