Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Dose Ranging Study Of Bococizumab (PF-04950615; RN316) In Hypercholesterolemic Japanese Subjects

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT02055976
First received: January 22, 2014
Last updated: November 4, 2014
Last verified: November 2014
  Purpose

The purpose of this study is to evaluate the low density lipoprotein cholesterol (LDL-C) lowering effect of Bococizumab (PF-04950615;RN316) administered subcutaneously at every two weeks (Q14D) in hypercholesterolemic Japanese subjects whose LDL-C is not controlled by a stable dose of atorvastatin, or who are naïve to a treatment by lipid lowering drug and whose LDL-C is not controlled.


Condition Intervention Phase
Hypercholesterolemia
Drug: Bococizumab (PF-04950615;RN316)
Drug: Placebo
Drug: Ezetimibe
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Double Blind, Parallel Group, Placebo Controlled, Randomized, Dose Ranging Study To Assess The Efficacy, Safety And Tolerability Of PF-04950615 Following Twice Monthly Subcutaneous Doses In Hypercholesterolemic Japanese Subjects Who Are Receiving A Stable Dose Of Atorvastatin Or Treatment Naïve.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percent Change from Baseline in LDL-C at Week 12 and 16 [ Time Frame: Week 12 and 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Actual Value and Change from Baseline in LDL-C [ Time Frame: Baseline, Week 12 and 16 ] [ Designated as safety issue: No ]
  • Actual Value, Change from Baseline and Percent Change from Baseline in Lipid parameters [ Time Frame: Baseline, Week 12 and 16 ] [ Designated as safety issue: No ]
    Total Cholesterol (TC), ApoB, ApoA-I, ApoA-II, Lp(a), High Density Lipoprotein Cholesterol, VLDL-C, Triglyceride, Non-HDL-cholesterol, TC/HDL-C ratio and ApoB/ApoA-I ratio.

  • Proportion of subjects having LDL-C less than particular limits (<100 mg/dL, <70 mg/dL, <40 mg/dL, <25 mg/dL, <10 mg/dL) [ Time Frame: Week 12 and 16 ] [ Designated as safety issue: No ]
  • Anti-drug antibody (ADA) [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
  • Area Under the Curve (AUC) [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
  • Minimum Observed Plasma Trough Concentration (Cmin) [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
  • Plasma Decay Half-Life (t1/2) [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
  • Plasma concentration of PCSK9 [ Time Frame: Week 20 ] [ Designated as safety issue: No ]

Estimated Enrollment: 216
Study Start Date: March 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Population A
A total of 9 groups in two population. Population A comprises hypercholesterolemic Japanese subjects whose LDL-C is not controlled by a stable dose of atorvastatin. A subject who is receiving a stable dose of atorvastatin will be randomized into one out of 5 dose groups.
Drug: Bococizumab (PF-04950615;RN316)
Atorvastatin plus PF-04950615 50 mg subcutaneous administration at every two weeks (Q14D SC) for 16 week
Other Name: Bococizumab (PF-04950615;RN316)
Drug: Bococizumab (PF-04950615;RN316)
Atorvastatin plus PF-04950615 100 mg Q14D SC for 16 week
Other Name: Bococizumab (PF-04950615;RN316)
Drug: Bococizumab (PF-04950615;RN316)
Atorvastatin plus PF-04950615 150 mg Q14D SC for 16 week
Other Name: Bococizumab (PF-04950615;RN316)
Drug: Placebo
Atorvastatin plus PF-04950615 Placebo Q14D SC for 16 week
Drug: Ezetimibe
Atorvastatin plus Ezetimibe 10 mg oral administration once daily for 16 week (open)
Experimental: Population B
A total of 9 groups in two population. Population B comprises hypercholesterolemic Japanese subjects who are naïve for a treatment by lipid lowering drug and whose fasting LDL-cholesterol is not controlled. A subject who is treatment naïve will be randomized into one out of 4 dose groups.
Drug: Bococizumab (PF-04950615;RN316)
50 mg Q14D SC for 16 week
Other Name: Bococizumab (PF-04950615;RN316)
Drug: Bococizumab (PF-04950615;RN316)
100 mg Q14D SC for 16 week
Other Name: Bococizumab (PF-04950615;RN316)
Drug: Bococizumab (PF-04950615;RN316)
150 mg Q14D SC for 16 week
Other Name: Bococizumab (PF-04950615;RN316)
Drug: Placebo
Placebo Q14D SC for 16 week

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects whose LDL-C is not controlled by a stable dose of atorvastatin (Population A).
  • Subjects who are naïve to a treatment by lipid lowering drug and whose LDL-C is not controlled (Population B).

Exclusion Criteria:

  • Severe acute or chronic medical or psychiatric condition or laboratory abnormality.
  • Pregnant females; breastfeeding females; males and females of childbearing potential; males and females of childbearing potential who are unwilling or unable to use a highly effective method of contraception.
  • Subjects who were administered or prior exposed to PF-04950615 and/or anti-body targeting PCSK9.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02055976

Locations
Japan
Maebashi Hirosegawa Clinic
Maebashi, Gunma, Japan, 371-0022
Yokohama Minoru Clinic
Yokohama, Kanagawa, Japan, 232-0064
Heishinkai Medical Group Incorporated OCROM Clinic
Suita, Osaka, Japan, 565-0853
Meiwa Hospital
Chiyoda-ku, Tokyo, Japan, 101-0041
Tokyo-Eki Center-building Clinic
Chuo-ku, Tokyo, Japan, 103-0027
Clinical Research Hospital Tokyo
Shinjuku-ku, Tokyo, Japan, 162-0053
Heishinkai Medical Group Incorporated ToCROM Clinic
Shinjuku-ku, Tokyo, Japan, 160-0022
Oda Clinic
Shinjuku-ku, Tokyo, Japan, 169-0072
Sekino Hospital
Toshima-ku, Tokyo, Japan, 171-0014
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02055976     History of Changes
Other Study ID Numbers: B1481036
Study First Received: January 22, 2014
Last Updated: November 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
PF-04950615
Japan

Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Ezetimibe
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014