DyslipidemiaPhase 2NCT01112423
Safety Study of BMS-823778 in Subjects With Hypercholesterolemia
A Phase 2 study testing BMS-823778 in people with Dyslipidemia, run by Bristol-Myers Squibb at 12 sites in 3 countries.
Trial summary
The purpose of this study is to assess the safety, tolerability and pharmacodynamic effects on LDL cholesterol (LDL-C) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- BMS-823778
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 12 sitesin 3 countries
- Study dates
- Jun 2010to Dec 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypercholesterolemia
- Currently taking a stable daily dose of statin therapy
- Serum triglyceride level < 500mg/dl
Who cannot join
- 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
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
United States6 sites
Sterling Research Grp, Ltd.
Cincinnati, Ohio, 45219
Pra International
Lenexa, Kansas, 66219
Osborne Research Center
Little Rock, Arkansas, 72201
National Clinical Research - Norfolk, Inc.
Norfolk, Virginia, 23502
National Clinical Research - Richmond, Inc.
Richmond, Virginia, 23294
Cetero Research - San Antonio
San Antonio, Texas, 78229
Canada5 sites
Local Institution
Drummondville, Quebec, J2B 7T1
Local Institution
London, Ontario, N6A 5R8
Local Institution
Montreal, Quebec, H3J 2V5
Local Institution
Mount Pearl, Newfoundland and Labrador, A1N 1W7
Local Institution
Winnipeg, Manitoba, R2V 4W3
About this study
Official 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
The purpose of this study is to assess the safety, tolerability and pharmacodynamic effects on LDL cholesterol (LDL-C)
- Conditions
- Dyslipidemia
- Being tested
- BMS-823778, Placebo
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-823778Drug
Capsules, Oral, 2 mg, once daily, 28 days
BMS-823778Drug
Capsules, Oral, 10 mg, once daily, 28 days
BMS-823778Drug
Capsules, Oral, 20 mg, once daily, 28 days
PlaceboDrug
Capsules, Oral, 0 mg, once daily, 28 days
| Study group | Role | What they receive |
|---|---|---|
| BMS-823778 (2 mg) | Experimental | Not described Receives: Drug: BMS-823778 |
| BMS-823778 (10 mg) | Experimental | Not described Receives: Drug: BMS-823778 |
| BMS-823778 (20 mg) | Experimental | Not described Receives: Drug: BMS-823778 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lowering of LDL-C
Measured: Within 28 days following dosing
Secondary outcomes (2)
Pharmacokinetics (measuring trough concentrations)
Measured: 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)
Measured: Within 28 days following dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01112423
- Sponsor's protocol ID
- MB121-003
- Status last verified
- Sep 2015
- First submitted
- 23 Apr 2010
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01112423
- Acronym / sponsor ID
- MB121-003
- Conditions
- Dyslipidemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 28 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety, tolerability and pharmacodynamic effects on LDL cholesterol (LDL-C)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hypercholesterolemia
- Currently taking a stable daily dose of statin therapy
- Serum triglyceride level < 500mg/dl
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-823778Capsules, Oral, 2 mg, once daily, 28 days | Drug | BMS-823778 (2 mg) |
| BMS-823778Capsules, Oral, 10 mg, once daily, 28 days | Drug | BMS-823778 (10 mg) |
| BMS-823778Capsules, Oral, 20 mg, once daily, 28 days | Drug | BMS-823778 (20 mg) |
| PlaceboCapsules, Oral, 0 mg, once daily, 28 days | Drug | Placebo |
Primary outcome
Lowering of LDL-C
Time frame: Within 28 days following dosing
2 secondary outcomes
Pharmacokinetics (measuring trough concentrations)
Time frame: 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)
Time frame: Within 28 days following dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BMS-823778 in people with Dyslipidemia, run by Bristol-Myers Squibb at 12 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Canada, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lowering of LDL-C (time frame: Within 28 days following dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2015.