NCT01058083

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2010

Shorter than P25 for phase_2

Geographic Reach
3 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 28, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

April 19, 2012

Status Verified

April 1, 2012

Enrollment Period

10 months

First QC Date

January 26, 2010

Last Update Submit

April 18, 2012

Conditions

Dyslipidemia

Outcome Measures

Primary Outcomes (1)

  • Lowering of LDL-C

    Within 28 days following dosing

Secondary Outcomes (2)

  • Pharmacokinetics (Blood Level) of BMS-770767

    Within 28 days following dosing

  • Pharmacodynamic effects of BMS-770767 on Total cholesterol, HDL-C, Triglycerides, non-HDL-C, non-esterified free fatty acids, Apolipoprotein fractions, HPA axis marker and free testosterone and sex hormone binding globulin (SHBG)

    Within 28 days following dosing

Study Arms (5)

BMS-770767 (Treatment A)

EXPERIMENTAL
Drug: BMS-770767

BMS-770767 (Treatment B)

EXPERIMENTAL
Drug: BMS-770767

BMS-770767 (Treatment C)

EXPERIMENTAL
Drug: BMS-770767

BMS-770767 (Treatment D)

EXPERIMENTAL
Drug: BMS-770767

Placebo (Treatment E)

PLACEBO COMPARATOR
Drug: Placebo

Interventions

BMS-770767DRUG

Active, Oral, 15 mg, Daily, 28 days

BMS-770767 (Treatment A)
PlaceboDRUG

Placebo, Oral, 0 mg, daily, 28 days

Placebo (Treatment E)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Harrell, Robert

Little Rock, Arkansas, 72201, United States

Location

Cetero Research - San Antonio

San Antonio, Texas, 78229, United States

Location

Local Institution

Blacktown, New South Wales, 2148, Australia

Location

Local Institution

Hornsby, New South Wales, 2077, Australia

Location

Local Institution

Caboolture, Queensland, 4510, Australia

Location

Local Institution

South Brisbane, Queensland, 4101, Australia

Location

Local Institution

Daw Park, South Australia, 5041, Australia

Location

Local Institution

Nedlands, Western Australia, 6004, Australia

Location

Local Institution

Bathurst, New Brunswick, E2A 4X7, Canada

Location

Local Institution

Brampton, Ontario, L6T 3J1, Canada

Location

Local Institution

Toronto, Ontario, M8V 3X8, Canada

Location

Local Institution

Charlottetown, Prince Edward Island, C1A 5Y9, Canada

Location

Local Institution

Mirabel, Quebec, J7J 2K8, Canada

Location

Local Institution

Montreal, Quebec, H3J 2V5, Canada

Location

Related Links

MeSH Terms

Conditions

Dyslipidemias

Interventions

BMS-770767

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

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

January 26, 2010

First Posted

January 28, 2010

Study Start

May 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

April 19, 2012

Record last verified: 2012-04

Locations

US(2)AU(6)CA(6)