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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01112423




Registration number
NCT01112423
Ethics application status
Date submitted
23/04/2010
Date registered
28/04/2010
Date last updated
12/10/2015

Titles & IDs
Public title
Safety Study of BMS-823778 in Subjects With Hypercholesterolemia
Scientific title
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
Secondary ID [1] 0 0
MB121-003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dyslipidemia 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BMS-823778
Treatment: Drugs - BMS-823778
Treatment: Drugs - BMS-823778
Treatment: Drugs - Placebo

Experimental: BMS-823778 (2 mg) -

Experimental: BMS-823778 (10 mg) -

Experimental: BMS-823778 (20 mg) -

Placebo Comparator: Placebo -


Treatment: Drugs: BMS-823778
Capsules, Oral, 2 mg, once daily, 28 days

Treatment: Drugs: BMS-823778
Capsules, Oral, 10 mg, once daily, 28 days

Treatment: Drugs: BMS-823778
Capsules, Oral, 20 mg, once daily, 28 days

Treatment: Drugs: Placebo
Capsules, Oral, 0 mg, once daily, 28 days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Lowering of LDL-C
Timepoint [1] 0 0
Within 28 days following dosing
Secondary outcome [1] 0 0
Pharmacokinetics (measuring trough concentrations)
Timepoint [1] 0 0
On days 7, 14, and 28
Secondary outcome [2] 0 0
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)
Timepoint [2] 0 0
Within 28 days following dosing

Eligibility
Key inclusion criteria
- Hypercholesterolemia

- Currently taking a stable daily dose of statin therapy

- Serum triglyceride level < 500mg/dl
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2010
Sample size
Target
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Local Institution - Brisbane
Recruitment postcode(s) [1] 0 0
4021 - Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
Kansas
Country [3] 0 0
United States of America
State/province [3] 0 0
Ohio
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
United States of America
State/province [5] 0 0
Virginia
Country [6] 0 0
Canada
State/province [6] 0 0
Manitoba
Country [7] 0 0
Canada
State/province [7] 0 0
Newfoundland and Labrador
Country [8] 0 0
Canada
State/province [8] 0 0
Ontario
Country [9] 0 0
Canada
State/province [9] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the safety, tolerability and pharmacodynamic effects
on LDL cholesterol (LDL-C)
Trial website
https://clinicaltrials.gov/ct2/show/NCT01112423
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries