NCT01112423|CompletedPhase 2

Safety Study of BMS-823778 in Subjects With Hypercholesterolemia

A Double-Blind, Placebo-Controlled, Parallel-Group, Randomized, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of BMS-823778 in Non-Diabetic Subjects With Primary Hypercholesterolemia on a Stable Dose of Statin Therapy With or Without Ezetimibe

Bristol-Myers Squibb ClinicalTrials.gov

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1 other identifier

MB121-003

Study Type

interventional

Target

Locations

3 countries

Sites

Timeline

RegisteredApr 2010

StartedJun 2010

CompletionDec 2010

Brief Summary

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

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Jun 2010

Shorter than P25 for phase_2

Geographic Reach

3 countries

12 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

6 months study duration

First Submitted

Initial submission to the registry

April 23, 2010

Completed

5 days until next milestone

First Posted

Study publicly available on registry

April 28, 2010

Completed

1 month until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed

6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed

Last Updated

October 12, 2015

Status Verified

September 1, 2015

Enrollment Period

6 months

First QC Date

April 23, 2010

Last Update Submit

September 23, 2015

Conditions

Dyslipidemia

Outcome Measures

Primary Outcomes (1)

Lowering of LDL-C
Within 28 days following dosing

Secondary Outcomes (2)

Pharmacokinetics (measuring trough concentrations)
On days 7, 14, and 28
Pharmacodynamic effects of BMS-823778 on Total cholesterol, HDL-C, Triglycerides, non-HDL-C, free fatty acids, Apolipoprotein fractions, HPA axis marker and free testosterone and sex hormone binding globulin (SHBG)
Within 28 days following dosing

Study Arms (4)

BMS-823778 (2 mg)

EXPERIMENTAL

Drug: BMS-823778

BMS-823778 (10 mg)

EXPERIMENTAL

Drug: BMS-823778

BMS-823778 (20 mg)

EXPERIMENTAL

Drug: BMS-823778

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BMS-823778DRUG

Capsules, Oral, 2 mg, once daily, 28 days

BMS-823778 (2 mg)

PlaceboDRUG

Capsules, Oral, 0 mg, once daily, 28 days

Placebo

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

Bristol-Myers Squibblead

Study Sites (12)

Osborne Research Center

Little Rock, Arkansas, 72201, United States

Location

Pra International

Lenexa, Kansas, 66219, United States

Location

Sterling Research Grp, Ltd.

Cincinnati, Ohio, 45219, United States

Location

Cetero Research - San Antonio

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

Local Institution

Brisbane, Queensland, 4021, Australia

Location

Local Institution

Winnipeg, Manitoba, R2V 4W3, Canada

Location

Local Institution

Mount Pearl, Newfoundland and Labrador, A1N 1W7, Canada

Location

Local Institution

London, Ontario, N6A 5R8, Canada

Location

Local Institution

Drummondville, Quebec, J2B 7T1, Canada

Location

Local Institution

Montreal, Quebec, H3J 2V5, Canada

Location

MeSH Terms

Conditions

Dyslipidemias

Interventions

BMS-823778

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, CARE PROVIDER, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 23, 2010

First Posted

April 28, 2010

Study Start

June 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

October 12, 2015

Record last verified: 2015-09

Locations

CA(5)US(6)AU(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (4)

BMS-823778 (2 mg)

BMS-823778 (10 mg)

BMS-823778 (20 mg)

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (12)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations