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

NCT01592240 | Completed Phase 2 Results

• 2 other identifiers: B14810152012-001226-10
• Study Type: interventional
• Target: 354
• Locations: 1 country
• Sites: 74

Brief 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.

Conditions

Hypercholesterolemia

Keywords

PF-04950615; RN316

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12

  Baseline, Week 12

Secondary Outcomes (24)

• Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24

  Baseline, Week 24

• Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 and 24

  Baseline, Week 12, 24

• Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24

  Baseline, Week 12, 24

• Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24

  Baseline, Week 12, 24

• Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24

  Baseline, Week 12, 24

Study Arms (2)

Q28d Dosing Arm

EXPERIMENTAL

A total of 7 dose groups in two dosing schedules, 50 subjects per dose group are planned. Q28d dose group will receive subcutaneous administration of PF-04950615 or Placebo once a month.

Drug: PBO; Drug: 200mg PF-04950615 (RN316); Drug: 300mg PF-04950615 (RN316)

Q14d Dosing Arm

EXPERIMENTAL

A total of 7 dose groups in two dosing schedules, 50 subjects per dose group are planned. Q14d dose group will receive subcutaneous administration of PF-04950615 or Placebo every 2 weeks.

Drug: PBO; Drug: PF-04950615

Interventions

PBO DRUG

Placebo Q28d

Q28d Dosing Arm

200mg PF-04950615 (RN316) DRUG

PF-04950615 200 mg, Q28d

Also known as: PF-04950615 (RN316)

Q28d Dosing Arm

300mg PF-04950615 (RN316) DRUG

PF-04950615 300 mg, Q28d

Also known as: PF-04950615 (RN316)

Q28d Dosing Arm

PF-04950615 DRUG

PF-04950615 50mg, Q14d

Also known as: PF-04950615 (RN316)

Q14d Dosing Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (74)

Achieve Clinical Research, LLC

Birmingham, Alabama, 35216, United States

Location

Medical Affiliated Research Center, Inc.

Huntsville, Alabama, 35801, United States

Location

The Office of James G. McMurray, MD

Huntsville, Alabama, 35801, United States

Location

Southwest Heart Group

Tucson, Arizona, 85710, United States

Location

Aureus Research Inc.

Little Rock, Arkansas, 72205, United States

Location

Universal Biopharma Research Institute Inc. - Alta Family Health Clinic

Dinuba, California, 93618, United States

Location

Clinical Trials Research

Lincoln, California, 95648, United States

Location

The Office of Lucita M. Cruz, MD, Inc.

Norwalk, California, 90650, United States

Location

Radiant Research

Santa Rosa, California, 95405, United States

Location

St. Joseph's Medical Associates

Stockton, California, 95204, United States

Location

Orange County Research Center

Tustin, California, 92780, United States

Location

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

Chase Medical Research, LLC

Waterbury, Connecticut, 06708, United States

Location

Zasa Clinical Research

Boynton Beach, Florida, 33472, United States

Location

Florida Health Center

Davie, Florida, 33312, United States

Location

Avail Clinical Research, LLC

DeLand, Florida, 32720, United States

Location

Florida Research Network, LLC

Gainesville, Florida, 32605, United States

Location

In Vivo Clinical Research, Inc.

Hialeah, Florida, 33010, United States

Location

Health Care Family Rehab and Research Center

Hialeah, Florida, 33012, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Community Research Foundation, Inc.

Miami, Florida, 33155, United States

Location

Kendall South Medical Center, Inc.

Miami, Florida, 33185, United States

Location

Omega Research Consultants, LLC

Orlando, Florida, 32804, United States

Location

DMI Research

Pinellas Park, Florida, 33782, United States

Location

St Johns Center for Clinical Research

Ponte Vedra, Florida, 32081, United States

Location

The Office of Bridget Bellingar, DO

Seminole, Florida, 33774, United States

Location

Miami Research Associates

South Miami, Florida, 33143, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30308, United States

Location

Radiant Research, Inc.

Atlanta, Georgia, 30328, United States

Location

North Georgia Clinical Research

Woodstock, Georgia, 30189, United States

Location

East-West Medical Research Institute

Honolulu, Hawaii, 96814, United States

Location

Northwest Clinical Trials

Boise, Idaho, 83704, United States

Location

Fox Valley Clinical Research Center, LLC

Aurora, Illinois, 60504, United States

Location

Radiant Research, Inc.

Chicago, Illinois, 60654, United States

Location

Midwest Institute for Clinical Research

Indianapolis, Indiana, 46260, United States

Location

Midwest Heart & Vascular Specialists

Overland Park, Kansas, 66209, United States

Location

L-MARC Research Center

Louisville, Kentucky, 40213, United States

Location

Crescent City Clinical Research Center

Metairie, Louisiana, 70006, United States

Location

Maine Research Associates

Auburn, Maine, 04210, United States

Location

Maine Research Associates

Lewiston, Maine, 04240, United States

Location

ActivMed Practices and Research

Haverhill, Massachusetts, 01830, United States

Location

Radiant Research, Inc.

Edina, Minnesota, 55435, United States

Location

Dybedal Clinical Research Center

Kansas City, Missouri, 64106, United States

Location

Montana Medical Research, Inc.

Missoula, Montana, 59808, United States

Location

Meridian Clinical Research

Omaha, Nebraska, 68134, United States

Location

New Mexico Clinical Research and Osteoporosis Center, Inc.

Albuquerque, New Mexico, 87106, United States

Location

Central New York Clinical Research

Manlius, New York, 13104, United States

Location

Clinical Trials of America, Inc.

Hickory, North Carolina, 28601, United States

Location

North Carolina Clinical Research

Raleigh, North Carolina, 27607, United States

Location

PMG Research of Raleigh

Raleigh, North Carolina, 27609, United States

Location

Wake Internal Medicine Consultants

Raleigh, North Carolina, 27612, United States

Location

PMG Research of Salisbury

Salisbury, North Carolina, 28144, United States

Location

Ardmore Family Practice

Winston-Salem, North Carolina, 27103, United States

Location

Clinical Trials of America, Inc.

Winston-Salem, North Carolina, 27103, United States

Location

Sterling Research Group, Ltd.

Cincinnati, Ohio, 45219, United States

Location

Sentral Clinical Research Services

Cincinnati, Ohio, 45236, United States

Location

Sterling Research Group, LTD.

Cincinnati, Ohio, 45246, United States

Location

Albert J. Weisbrot, M.D., Inc.

Mason, Ohio, 45040, United States

Location

Lynn Institute of Norman

Norman, Oklahoma, 73069, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Upstate Pharmaceutical Research

Greenville, South Carolina, 29615, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

Palmetto Clinical Research

Summerville, South Carolina, 29485, United States

Location

New Orleans Center for Clinical Research

Knoxville, Tennessee, 37920, United States

Location

Volunteer Research Group

Knoxville, Tennessee, 37920, United States

Location

Baylor College of Medicine - Center for Cardiovascular Disease Prevention

Houston, Texas, 77030, United States

Location

Texas Center for Drug Development, Inc.

Houston, Texas, 77081, United States

Location

Protenium Clinical Research, LLC

Hurst, Texas, 76054, United States

Location

Paragon Research Center, LLC

San Antonio, Texas, 78205, United States

Location

Innovative Clinical Trials

San Antonio, Texas, 78229, United States

Location

National Clinical Research- Norfolk, Inc

Norfolk, Virginia, 23502, United States

Location

National Clinical Research - Richmond, Inc.

Richmond, Virginia, 23294, United States

Location

Premier Clinical Research

Spokane, Washington, 99204, United States

Location

Related Publications (2)

• Wang EQ, Kaila N, Plowchalk D, Gibiansky L, Yunis C, Sweeney K. Population PK/PD modeling of low-density lipoprotein cholesterol response in hypercholesterolemic participants following administration of bococizumab, a potent anti-PCSK9 monoclonal antibody. CPT Pharmacometrics Syst Pharmacol. 2023 Dec;12(12):2013-2026. doi: 10.1002/psp4.13050. Epub 2023 Nov 22.

  PMID: 37994400 DERIVED

• Ballantyne CM, Neutel J, Cropp A, Duggan W, Wang EQ, Plowchalk D, Sweeney K, Kaila N, Vincent J, Bays H. Results of bococizumab, a monoclonal antibody against proprotein convertase subtilisin/kexin type 9, from a randomized, placebo-controlled, dose-ranging study in statin-treated subjects with hypercholesterolemia. Am J Cardiol. 2015 May 1;115(9):1212-21. doi: 10.1016/j.amjcard.2015.02.006. Epub 2015 Feb 12.

  PMID: 25784512 DERIVED

Related Links

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

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

bococizumab

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Limitations and Caveats

There were no limitations or caveats in this study.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2012
• First Posted: May 7, 2012
• Study Start: July 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: May 1, 2013
• Last Updated: December 5, 2017
• Results First Posted: December 5, 2017

Record last verified: 2017-10

Locations

US (74)