DyslipidemiaPhase 2NCT01058083
Safety Study of BMS-770767 in Subjects With Hypercholesterolemia
A Phase 2 study testing BMS-770767 in people with Dyslipidemia, run by Bristol-Myers Squibb at 14 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-770767
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 14 sitesin 3 countries
- Study dates
- May 2010to Mar 2011
- 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
14 sites in 3 countries.
14 sites in 3 countries
Australia6 sites
Local Institution
Blacktown, New South Wales, 2148
Local Institution
Caboolture, Queensland, 4510
Local Institution
Daw Park, South Australia, 5041
Local Institution
Hornsby, New South Wales, 2077
Local Institution
Nedlands, Western Australia, 6004
Local Institution
South Brisbane, Queensland, 4101
Canada6 sites
Local Institution
Bathurst, New Brunswick, E2A 4X7
Local Institution
Brampton, Ontario, L6T 3J1
Local Institution
Charlottetown, Prince Edward Island, C1A 5Y9
Local Institution
Mirabel, Quebec, J7J 2K8
Local Institution
Montreal, Quebec, H3J 2V5
Local Institution
Toronto, Ontario, M8V 3X8
United States2 sites
Harrell, Robert
Little Rock, Arkansas, 72201
Cetero Research - San Antonio
San Antonio, Texas, 78229
About this study
Official title: A Double-blind, Placebo-Controlled, Parallel-Group, Randomized, Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic Effects of BMS-770767 in Subjects With Primary Hypercholesterolemia
The purpose of this study is to assess the safety, tolerability and pharmacodynamic effects on LDL cholesterol (LDL-C)
- Conditions
- Dyslipidemia
- Being tested
- BMS-770767, 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-770767Drug
Active, Oral, 15 mg, Daily, 28 days
BMS-770767Drug
Active, Oral, 50 mg, Daily, 28 days
BMS-770767Drug
Active, Oral, 150 mg, Daily, 28 days
BMS-770767Drug
Active, Oral, 50 mg BID, Daily, 28 days
PlaceboDrug
Placebo, Oral, 0 mg, daily, 28 days
| Study group | Role | What they receive |
|---|---|---|
| BMS-770767 (Treatment A) | Experimental | Not described Receives: Drug: BMS-770767 |
| BMS-770767 (Treatment B) | Experimental | Not described Receives: Drug: BMS-770767 |
| BMS-770767 (Treatment C) | Experimental | Not described Receives: Drug: BMS-770767 |
| BMS-770767 (Treatment D) | Experimental | Not described Receives: Drug: BMS-770767 |
| Placebo (Treatment E) | 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 (Blood Level) of BMS-770767
Measured: 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)
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 Jan 2010 (estimated)
- Study startMay 2010
- Primary completionMar 2011
- Study completionMar 2011
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, Investigator, Outcomes assessor
- Enrolment
- 81 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
- NCT01058083
- Sponsor's protocol ID
- MB117-004
- Other IDs
- 2009-014306-33, 2009
- Status last verified
- Apr 2012
- First submitted
- 26 Jan 2010
- Last updated
- 19 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2012. 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, Pharmacokinetics and Pharmacodynamic Effects of BMS-770767 in Subjects With Primary Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT01058083
- Acronym / sponsor ID
- MB117-004
- Conditions
- Dyslipidemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 28 Jan 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, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
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-770767Active, Oral, 15 mg, Daily, 28 days | Drug | BMS-770767 (Treatment A) |
| BMS-770767Active, Oral, 50 mg, Daily, 28 days | Drug | BMS-770767 (Treatment B) |
| BMS-770767Active, Oral, 150 mg, Daily, 28 days | Drug | BMS-770767 (Treatment C) |
| BMS-770767Active, Oral, 50 mg BID, Daily, 28 days | Drug | BMS-770767 (Treatment D) |
| PlaceboPlacebo, Oral, 0 mg, daily, 28 days | Drug | Placebo (Treatment E) |
Primary outcome
Lowering of LDL-C
Time frame: Within 28 days following dosing
2 secondary outcomes
Pharmacokinetics (Blood Level) of BMS-770767
Time frame: 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)
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 19 Apr 2012.
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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
14 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-770767 in people with Dyslipidemia, run by Bristol-Myers Squibb at 14 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 19 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Australia, Canada, United States. 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 19 Apr 2012.