Monthly And Twice Monthly Subcutaneous Dosing Of PF-04950615 (RN316) In Hypercholesterolemic Subjects On A Statin

Hypercholesterolemia Clinical Trial

Official title:

A Phase 2b Double-blind, Randomized, Placebo-controlled, Parallel Group, Dose-ranging Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 Following Monthly And Twice Monthly Subcutaneous Dosing For Six Months In Hypercholesterolemic Subjects On A Statin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01592240
• Other study ID #: B1481015
• Secondary ID: 2012-001226-10
• Status: Completed
• Phase: Phase 2
• First received: May 3, 2012
• Last updated: October 27, 2017
• Start date: July 2012
• Est. completion date: May 2013

Study information

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

Clinical Trial Summary

To evaluate the Low Density Lipoprotein-Cholesterol (LDL-C) lowering effect of PF-04950615 administered subcutaneously at monthly intervals, or twice monthly intervals in subjects with high cholesterol whose LDL-cholesterol is >/=80 mg/dL on background treatment with a statin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 354
• Est. completion date: May 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects should be receiving a stable dose (at least 6 weeks) of any statin and continue on same dose of statin for the duration of this trial.

• Lipids should meet the following criteria on a background treatment with a statin at 2 screening visits that occur at screening and at least 7 days prior to randomization on Day 1:

• Fasting LDL-C greater than or equal to 80 mg/dL (2.31 mmol/L);

• Fasting TG less than or equal to 400 mg/dL (4.52 mmol/L).

• Subject's fasting LDL-cholesterol must greater than or equal to 80 mg/dL (2.31 mmol/L at the initial screening visit, and the value at the second visit within 7 days of randomization must be not lower than 20% of this initial value to meet eligibility criterion for this trial.

Exclusion Criteria:

• Participation in other studies within 3 months before the current study begins and/or during study participation.

• Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

• Pregnant females; breastfeeding females; males and females of childbearing potential not using highly effective contraception or not agreeing to continue highly effective contraception for at least 63 days after last dose of investigational product.

• History of a cardiovascular or cerebrovascular event or procedure (eg, MI, stroke, TIA, angioplasty) during the past 6 months. Congestive heart failure (CHF), NYHA functional classes III or IV.

• Poorly controlled type 1 or type 2 diabetes mellitus (defined as HbA1c >9%).

• Poorly controlled hypertension.

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• PBO
Placebo Q28d
• 200mg PF-04950615 (RN316)
PF-04950615 200 mg, Q28d
• 300mg PF-04950615 (RN316)
PF-04950615 300 mg, Q28d
• PBO
Placebo, Q14d
• PF-04950615
PF-04950615 50mg, Q14d
• PF-04950615
PF-04950615 100 mg, Q14d
• PF-04950615
PF-04950615 150mg, Q14d

Locations

Country	Name	City	State
United States	New Mexico Clinical Research and Osteoporosis Center, Inc.	Albuquerque	New Mexico
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	Radiant Research, Inc.	Atlanta	Georgia
United States	Maine Research Associates	Auburn	Maine
United States	Fox Valley Clinical Research Center, LLC	Aurora	Illinois
United States	Achieve Clinical Research, LLC	Birmingham	Alabama
United States	Northwest Clinical Trials	Boise	Idaho
United States	Zasa Clinical Research	Boynton Beach	Florida
United States	Radiant Research, Inc.	Chicago	Illinois
United States	Sentral Clinical Research Services	Cincinnati	Ohio
United States	Sterling Research Group, LTD.	Cincinnati	Ohio
United States	Sterling Research Group, Ltd.	Cincinnati	Ohio
United States	Florida Health Center	Davie	Florida
United States	Avail Clinical Research, LLC	DeLand	Florida
United States	Universal Biopharma Research Institute Inc. - Alta Family Health Clinic	Dinuba	California
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Radiant Research, Inc.	Edina	Minnesota
United States	Florida Research Network, LLC	Gainesville	Florida
United States	Upstate Pharmaceutical Research	Greenville	South Carolina
United States	ActivMed Practices and Research	Haverhill	Massachusetts
United States	Health Care Family Rehab and Research Center	Hialeah	Florida
United States	In Vivo Clinical Research, Inc.	Hialeah	Florida
United States	Clinical Trials of America, Inc.	Hickory	North Carolina
United States	East-West Medical Research Institute	Honolulu	Hawaii
United States	Baylor College of Medicine - Center for Cardiovascular Disease Prevention	Houston	Texas
United States	Texas Center for Drug Development, Inc.	Houston	Texas
United States	Medical Affiliated Research Center, Inc.	Huntsville	Alabama
United States	The Office of James G. McMurray, MD	Huntsville	Alabama
United States	Protenium Clinical Research, LLC	Hurst	Texas
United States	Midwest Institute for Clinical Research	Indianapolis	Indiana
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Dybedal Clinical Research Center	Kansas City	Missouri
United States	New Orleans Center for Clinical Research	Knoxville	Tennessee
United States	Volunteer Research Group	Knoxville	Tennessee
United States	Maine Research Associates	Lewiston	Maine
United States	Clinical Trials Research	Lincoln	California
United States	Aureus Research Inc.	Little Rock	Arkansas
United States	L-MARC Research Center	Louisville	Kentucky
United States	Central New York Clinical Research	Manlius	New York
United States	Albert J. Weisbrot, M.D., Inc.	Mason	Ohio
United States	Crescent City Clinical Research Center	Metairie	Louisiana
United States	Community Research Foundation, Inc.	Miami	Florida
United States	Kendall South Medical Center, Inc.	Miami	Florida
United States	Montana Medical Research, Inc.	Missoula	Montana
United States	Coastal Carolina Research Center	Mount Pleasant	South Carolina
United States	National Clinical Research- Norfolk, Inc	Norfolk	Virginia
United States	Lynn Institute of Norman	Norman	Oklahoma
United States	The Office of Lucita M. Cruz, MD, Inc.	Norwalk	California
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Meridian Clinical Research	Omaha	Nebraska
United States	Omega Research Consultants, LLC	Orlando	Florida
United States	Midwest Heart & Vascular Specialists	Overland Park	Kansas
United States	DMI Research	Pinellas Park	Florida
United States	St Johns Center for Clinical Research	Ponte Vedra	Florida
United States	North Carolina Clinical Research	Raleigh	North Carolina
United States	PMG Research of Raleigh	Raleigh	North Carolina
United States	Wake Internal Medicine Consultants	Raleigh	North Carolina
United States	National Clinical Research - Richmond, Inc.	Richmond	Virginia
United States	PMG Research of Salisbury	Salisbury	North Carolina
United States	Innovative Clinical Trials	San Antonio	Texas
United States	Paragon Research Center, LLC	San Antonio	Texas
United States	Radiant Research	Santa Rosa	California
United States	The Office of Bridget Bellingar, DO	Seminole	Florida
United States	Miami Research Associates	South Miami	Florida
United States	Premier Clinical Research	Spokane	Washington
United States	St. Joseph's Medical Associates	Stockton	California
United States	Palmetto Clinical Research	Summerville	South Carolina
United States	Southwest Heart Group	Tucson	Arizona
United States	Orange County Research Center	Tustin	California
United States	Diablo Clinical Research, Inc.	Walnut Creek	California
United States	Chase Medical Research, LLC	Waterbury	Connecticut
United States	Ardmore Family Practice	Winston-Salem	North Carolina
United States	Clinical Trials of America, Inc.	Winston-Salem	North Carolina
United States	North Georgia Clinical Research	Woodstock	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12		Baseline, Week 12
Secondary	Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24		Baseline, Week 24
Secondary	Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 and 24		Baseline, Week 12, 24
Secondary	Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24		Baseline, Week 12, 24
Secondary	Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24		Baseline, Week 12, 24
Secondary	Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24		Baseline, Week 12, 24
Secondary	Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24		Baseline, Week 12, 24
Secondary	Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24		Baseline, Week 12, 24
Secondary	Percent Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24		Baseline, Week 12, 24
Secondary	Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24		Baseline, Week 12, 24
Secondary	Percent Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24		Baseline, Week 12, 24
Secondary	Change From Baseline in Total Cholesterol at Week 12 and 24		Baseline, Week 12, 24
Secondary	Percent Change From Baseline in Total Cholesterol at Week 12 and 24		Baseline, Week 12, 24
Secondary	Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24		Baseline, Week 12, 24
Secondary	Percent Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24		Baseline, Week 12, 24
Secondary	Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24		Baseline, Week 12, 24
Secondary	Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24		Baseline, Week 12, 24
Secondary	Change From Baseline in Triglycerides at Week 12 and 24		Baseline, Week 12, 24
Secondary	Percent Change From Baseline in Triglycerides at Week 12 and 24		Baseline, Week 12, 24
Secondary	Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24		Baseline, Week 12, 24
Secondary	Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24		Baseline, Week 12, 24
Secondary	Percentage of Participants With Positive Anti-drug (Anti-PF-04950615) Antibodies (ADA)	Participants with titer value greater than or equal to 4.32 nanogram per milliliter were considered positive.	Baseline up to Day 211 for every 28 days groups and Baseline up to Day 225 for every 14 days groups
Secondary	Percentage of Participants With Injection Site Adverse Events	Injection site adverse events included injection site bruising, discomfort, erythema, hemorrhage, induration, inflammation, pain, paresthesia, pruritus, swelling, urticaria, reaction and rash.	Baseline up to Day 211 for 28 days groups and Baseline up to Day 225 for 14 days groups
Secondary	Plasma Concentration of PF-04950615 at Week 12 and 24		Week 12, 24
Secondary	Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)		Week 12, 24

External Links

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