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A Study To Assess The Safety Of PF-05335810 In Hypercholesterolemic Subjects

NCT ID: NCT01720537

Last Updated: 2018-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-10-31

Brief Summary

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This study is to evaluate the safety, tolerability and immunogenicity of single, ascending or multiple fixed subcutaneous and intravenous administrations of PF 05335810 to hypercholesterolemic subjects when added on to a daily statin dose.

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Detailed Description

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Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1

Group Type EXPERIMENTAL

PF-05335810 Dose A

Intervention Type BIOLOGICAL

Single SC Injection

Cohort 2

Group Type EXPERIMENTAL

PF-05335810 Dose B

Intervention Type BIOLOGICAL

Single Subcutaneous Injection(s)

Placebo

Intervention Type BIOLOGICAL

Single Subcutaneous Injection(s)

PF-05335810 Dose B

Intervention Type BIOLOGICAL

Single Intravenous Infusion

Placebo

Intervention Type BIOLOGICAL

Single Intravenous Infusion

PF-04950615 Dose A

Intervention Type BIOLOGICAL

Single Subcutaneous Injection(s)

PF-04950615 Dose A

Intervention Type BIOLOGICAL

Single Intravenous Infusion

Cohort 3

Group Type EXPERIMENTAL

PF-05335810 Dose C

Intervention Type BIOLOGICAL

Single Subcutaneous Injection(s)

Placebo

Intervention Type BIOLOGICAL

Single Subcutaneous Injection(s)

PF-05335810 Dose C

Intervention Type BIOLOGICAL

Single Intravenous Infusion

Placebo

Intervention Type BIOLOGICAL

Single Intravenous Infusion

PF-04950615

Intervention Type BIOLOGICAL

Single Subcutaneous Injection(s)

Cohort 4

Group Type EXPERIMENTAL

PF-05335810 Dose D

Intervention Type BIOLOGICAL

Single Subcutaneous Injection(s)

Placebo

Intervention Type BIOLOGICAL

Single Subcutaneous Injection(s)

Cohort 5

Group Type EXPERIMENTAL

PF-05335810 Dose E

Intervention Type BIOLOGICAL

Multiple fixed dosages administered in subcutaneous injections, monthly for 3 months.

Cohort 6

Group Type EXPERIMENTAL

PF-05335810 Dose D

Intervention Type BIOLOGICAL

Single Intravenous Infusion

Placebo

Intervention Type BIOLOGICAL

Single Intravenous Infusion

Interventions

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PF-05335810 Dose A

Single SC Injection

Intervention Type BIOLOGICAL

PF-05335810 Dose B

Single Subcutaneous Injection(s)

Intervention Type BIOLOGICAL

Placebo

Single Subcutaneous Injection(s)

Intervention Type BIOLOGICAL

PF-05335810 Dose B

Single Intravenous Infusion

Intervention Type BIOLOGICAL

Placebo

Single Intravenous Infusion

Intervention Type BIOLOGICAL

PF-04950615 Dose A

Single Subcutaneous Injection(s)

Intervention Type BIOLOGICAL

PF-04950615 Dose A

Single Intravenous Infusion

Intervention Type BIOLOGICAL

PF-05335810 Dose C

Single Subcutaneous Injection(s)

Intervention Type BIOLOGICAL

Placebo

Single Subcutaneous Injection(s)

Intervention Type BIOLOGICAL

PF-05335810 Dose C

Single Intravenous Infusion

Intervention Type BIOLOGICAL

Placebo

Single Intravenous Infusion

Intervention Type BIOLOGICAL

PF-04950615

Single Subcutaneous Injection(s)

Intervention Type BIOLOGICAL

PF-05335810 Dose D

Single Subcutaneous Injection(s)

Intervention Type BIOLOGICAL

Placebo

Single Subcutaneous Injection(s)

Intervention Type BIOLOGICAL

PF-05335810 Dose E

Multiple fixed dosages administered in subcutaneous injections, monthly for 3 months.

Intervention Type BIOLOGICAL

PF-05335810 Dose D

Single Intravenous Infusion

Intervention Type BIOLOGICAL

Placebo

Single Intravenous Infusion

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* On stable daily doses of a statin for 45 days prior to receiving study treatment.
* Fasting LDL C equal or greater than 80 mg/dL at screening and visit approximately 1 week prior to randomization.

Exclusion Criteria

* History of a cardiovascular or cerebrovascular event or procedure within one year of randomization.
* Poorly controlled type 1 or type 2 diabetes mellitus (defined as HbA1c \>9%).
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

New Haven, Connecticut, United States

Site Status

Pfizer Investigational Site

Miami, Florida, United States

Site Status

Pfizer Investigational Site

South Miami, Florida, United States

Site Status

Pfizer Investigational Site

Overland Park, Kansas, United States

Site Status

Pfizer Investigational Site

Kalamazoo, Michigan, United States

Site Status

Pfizer Investigational Site

Cincinnati, Ohio, United States

Site Status

Pfizer Investigational Site

San Antonio, Texas, United States

Site Status

Countries

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United States

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3091001&StudyName=A%20Study%20To%20Assess%20The%20Safety%20Of%20PF-05335810%20In%20Hypercholesterolemic%20Subjects

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

Other Identifiers

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B3091001

Identifier Type: -

Identifier Source: org_study_id

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