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Safety Study of BMS-770767 in Subjects With Hypercholesterolemia

NCT ID: NCT01058083

Last Updated: 2012-04-19

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

PHASE2

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-03-31

Brief Summary

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The purpose of this study is to assess the safety, tolerability and pharmacodynamic effects on LDL cholesterol (LDL-C)

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Detailed Description

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Conditions

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Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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BMS-770767 (Treatment A)

Group Type EXPERIMENTAL

BMS-770767

Intervention Type DRUG

Active, Oral, 15 mg, Daily, 28 days

BMS-770767 (Treatment B)

Group Type EXPERIMENTAL

BMS-770767

Intervention Type DRUG

Active, Oral, 50 mg, Daily, 28 days

BMS-770767 (Treatment C)

Group Type EXPERIMENTAL

BMS-770767

Intervention Type DRUG

Active, Oral, 150 mg, Daily, 28 days

BMS-770767 (Treatment D)

Group Type EXPERIMENTAL

BMS-770767

Intervention Type DRUG

Active, Oral, 50 mg BID, Daily, 28 days

Placebo (Treatment E)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo, Oral, 0 mg, daily, 28 days

Interventions

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BMS-770767

Active, Oral, 15 mg, Daily, 28 days

Intervention Type DRUG

BMS-770767

Active, Oral, 50 mg, Daily, 28 days

Intervention Type DRUG

BMS-770767

Active, Oral, 150 mg, Daily, 28 days

Intervention Type DRUG

BMS-770767

Active, Oral, 50 mg BID, Daily, 28 days

Intervention Type DRUG

Placebo

Placebo, Oral, 0 mg, daily, 28 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Hypercholesterolemia
* Currently taking a stable daily dose of statin therapy
* Serum triglyceride level \< 500mg/dl

Exclusion Criteria

* History of myocardial infarction, coronary angioplasty or bypass grafts, valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accidents within six months prior to entry into the study
* Congestive heart failure
* Diabetes mellitus
* Active liver disease
* Impaired renal function
* Hepatitis C, B and HIV

This list is not inclusive additional information is provided in the protocol
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Harrell, Robert

Little Rock, Arkansas, United States

Site Status

Cetero Research - San Antonio

San Antonio, Texas, United States

Site Status

Local Institution

Blacktown, New South Wales, Australia

Site Status

Local Institution

Hornsby, New South Wales, Australia

Site Status

Local Institution

Caboolture, Queensland, Australia

Site Status

Local Institution

South Brisbane, Queensland, Australia

Site Status

Local Institution

Daw Park, South Australia, Australia

Site Status

Local Institution

Nedlands, Western Australia, Australia

Site Status

Local Institution

Bathurst, New Brunswick, Canada

Site Status

Local Institution

Brampton, Ontario, Canada

Site Status

Local Institution

Toronto, Ontario, Canada

Site Status

Local Institution

Charlottetown, Prince Edward Island, Canada

Site Status

Local Institution

Mirabel, Quebec, Canada

Site Status

Local Institution

Montreal, Quebec, Canada

Site Status

Countries

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United States Australia Canada

Related Links

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http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

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2009-014306-33

Identifier Type: REGISTRY

Identifier Source: secondary_id

MB117-004

Identifier Type: -

Identifier Source: org_study_id

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