HypercholesterolemiaPhase 2NCT00405067
The Safety & Efficacy of Combination BMS-201038 (AEGR-733) & Ezetimibe vs. Monotherapy in Moderate Hypercholesterolemia
A Phase 2 study testing BMS-201038 (AEGR-733) and Ezetimibe in people with Hypercholesterolemia, run by Aegerion Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The main objectives of this study are to evaluate the efficacy and safety of combination therapy BMS-201038 (AEGR-733) plus ezetimibe vs. each agent given alone on LDL cholesterol and other lipoproteins over 12 weeks of therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- BMS-201038 (AEGR-733) and Ezetimibe
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Jan 2007
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women between the ages of 18 and 70 years .
- For subjects with 0 to 1 risk factor (cigarette smoking, hypertension (BP > 140/90 or on antihypertensive medication), low HDL (<40mg/dl), family history of premature CHD (CHD in male first degree relative <55 years; CHD in female first degree relative <65 years), age (men> 45 years; women > 55 years): Baseline mean LDL-C must be >160 and <250 mg/dl as determined by the arithmetic mean of measures taken at visit 1 and 2. Fasting mean TGs should be <400 mg/dl.
- For subjects with 2 or more risk factors (cigarette smoking, hypertension (BP > 140/90 or on antihypertensive medication), low HDL (<40mg/dl), family history of premature CHD (CHD in male first degree relative <55 years; CHD in female first degree relative <65 years), age (men> 45 years; women > 55 years) or prior stable CHD: Baseline mean LDL-C must be >130 and <250 mg/dl as determined by the arithmetic mean of measures taken at visit 1 and 2. Fasting mean TGs should be <400 mg/dl.
- Able to understand and willing to comply with all study requirements, particularly the study drug regimen.
- Able to understand and willing to sign the Informed Consent Form.
Who cannot join
- Women who are pregnant or lactating or who are planning to become pregnant or women of child bearing potential who have not successfully been using acceptable contraceptive methods over the previous 3 months (e.g. intrauterine device and barrier method plus spermicide).
- Uncontrolled hypertension defined as: systolic blood pressure > 180 mmHg, diastolic blood pressure > 95 mmHg
- History of chronic renal insufficiency (serum creatinine >2.5 mg/dL)
- History of liver disease or transaminases above 1.5 X ULN at screening
- Any major surgical procedure occurring less than 3 months prior to the screening visit
- Cardiac insufficiency defined by the NYHA classification as functional Class II-Class IV
Show all 14Show fewer
- History of a malignancy (other than basal cell or squamous cell carcinoma of the skin that has been removed) within the previous 5 years
- Participation in an investigational drug study within 6 weeks prior to the screening visit.
- Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
- Regular alcohol use > 1 drink per day
- Regular consumers of grapefruit juice, or currently taking medications known to be metabolized by CYP 3A4 (cyclosporine, itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, and nefazodone)
- Other lipid-lowering medications (washouts will be permitted)
- Acute CVD (CVD event within the previous 6 months)
- Diabetes Mellitus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Active Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of the Combination BMS-201038 (AEGR-733) and Ezetimibe vs. Monotherapy in Subjects With Moderate Hypercholesterolemia
The main objectives of this study are to evaluate the efficacy and safety of combination therapy BMS-201038 (AEGR-733) plus ezetimibe vs. each agent given alone on LDL cholesterol and other lipoproteins over 12 weeks of therapy.
Read the detailed description
Subjects will participate in this study for approximately 14-17 weeks. This study has 2 periods: 1) a 1-2-week screening period with 2 visits where baseline cholesterol and other characteristics will be evaluated to determine study eligibility. This period also includes a 4-week washout for patients on prior lipid-lowering therapies; and 2) a 12-week treatment period with interim visits at weeks 4 and 8.
85 subjects were randomized into one of 3 treatment arms with equal probability. In treatment arm 1, subjects will receive BMS-201038 (AEGR-733) 5 mg plus ezetimibe placebo. In treatment arm 2, subjects will receive BMS-201038 (AEGR-733) placebo plus 10 mg of ezetimibe. In treatment arm 3, subjects will receive BMS-201038 (AEGR-733) 5 mg plus ezetimibe 10 mg. After 4 weeks of treatment, subjects in arms 1 and 3 will be force-titrated to BMS-201038 (AEGR-733) 7.5 mg. After another 4 weeks of treatment, subjects in arms 1 and 3 will then be force-titrated to BMS-201038 (AEGR-733) 10 mg for 4 more additional weeks of treatment. Subjects in arm 2 will continue to receive BMS-201038 (AEGR-733) matching placebo for the entire 12 weeks of treatment. Subjects randomized to ezetimibe 10 mg in arms 2 and 3 and ezetimibe placebo in arm 1 will remain on these doses for the entire 12-week treatment period.
- Conditions
- Hypercholesterolemia
- Being tested
- BMS-201038 (AEGR-733), Ezetimibe
- Keywords
- Cholesterol
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-201038 (AEGR-733)Drug
EzetimibeDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in LDL-C at 12 Weeks Therapy Compared to Baseline Between Treatments
Measured: Baseline and 12 weeks of treatment
Secondary outcomes (9)
Percent of Change at 12 Weeks Therapy Compared to Baseline Between Treatments for the Following Parameters: Total Cholesterol (TC)
Measured: Baseline and 12 weeks of treatment
Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at 12 Weeks as Compared to Baseline.
Measured: Baseline and 12 weeks of treatment
Percent Change in Tryglycerides (TGs) at 12 Weeks Compared to Baseline
Measured: Baseline and 12 weeks of treatment
Percent Change in HDL-C at 12 Weeks Compared to Baseline
Measured: Baseline and 12 weeks of treatment
Percent Change in Lipoprotein(a)[Lp(a)]at 12 Weeks as Compared to Baseline
Measured: Baseline and 12 weeks of treatment
Percent Change in Apolipoprotein A1 (Apo A1) at 12 Weeks as Compared to Baseline
Measured: baseline and 12 weeks of treatment
Percent Change in Apolipoprotein B (Apo B) at 12 Weeks as Compared to Baseline
Measured: Baseline and 12 weeks of treatment
Percent Change in High-sensitivity C-reactive Protein (Hs-CRP) at 12 Weeks as Compared to Baseline
Measured: Baseline and 12 weeks of treatment
Percent Change in Body Weight at 12 Weeks as Compared to Baseline
Measured: Baseline and 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2006 (estimated)
- Study startMay 2006
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- 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
- Double blind
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aegerion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Davidson, MD, Principal investigator, Radiant ResearchJackson Downey, MD, Principal investigator, Jacksonville Center For Clinical ResearchPaul Grena, MD, Principal investigator, Cardiology Consultants of PhiladelphiaBarry Lubin, MD, Principal investigator, Hampton Roads Center for Clinical ResearchJames McKenney, Pharm D, Principal investigator, National Clinical ResearchEli Roth, MD, Principal investigator, Sterling Research Group, LTD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00405067
- Sponsor's protocol ID
- AEGR-733-001
- Status last verified
- Jan 2014
- First submitted
- 28 Nov 2006
- Last updated
- 4 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Active Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of the Combination BMS-201038 (AEGR-733) and Ezetimibe vs. Monotherapy in Subjects With Moderate Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT00405067
- Acronym / sponsor ID
- AEGR-733-001
- Conditions
- Hypercholesterolemia
- Keywords
- Cholesterol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Aegerion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 29 Nov 2006 (estimated)
- Results
- Posted 4 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objectives of this study are to evaluate the efficacy and safety of combination therapy BMS-201038 (AEGR-733) plus ezetimibe vs. each agent given alone on LDL cholesterol and other lipoproteins over 12 weeks of therapy.
Detailed description
Subjects will participate in this study for approximately 14-17 weeks. This study has 2 periods: 1) a 1-2-week screening period with 2 visits where baseline cholesterol and other characteristics will be evaluated to determine study eligibility. This period also includes a 4-week washout for patients on prior lipid-lowering therapies; and 2) a 12-week treatment period with interim visits at weeks 4 and 8.
85 subjects were randomized into one of 3 treatment arms with equal probability. In treatment arm 1, subjects will receive BMS-201038 (AEGR-733) 5 mg plus ezetimibe placebo. In treatment arm 2, subjects will receive BMS-201038 (AEGR-733) placebo plus 10 mg of ezetimibe. In treatment arm 3, subjects will receive BMS-201038 (AEGR-733) 5 mg plus ezetimibe 10 mg. After 4 weeks of treatment, subjects in arms 1 and 3 will be force-titrated to BMS-201038 (AEGR-733) 7.5 mg. After another 4 weeks of treatment, subjects in arms 1 and 3 will then be force-titrated to BMS-201038 (AEGR-733) 10 mg for 4 more additional weeks of treatment. Subjects in arm 2 will continue to receive BMS-201038 (AEGR-733) matching placebo for the entire 12 weeks of treatment. Subjects randomized to ezetimibe 10 mg in arms 2 and 3 and ezetimibe placebo in arm 1 will remain on these doses for the entire 12-week treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women between the ages of 18 and 70 years .
- For subjects with 0 to 1 risk factor (cigarette smoking, hypertension (BP > 140/90 or on antihypertensive medication), low HDL (<40mg/dl), family history of premature CHD (CHD in male first degree relative <55 years; CHD in female first degree relative <65 years), age (men> 45 years; women > 55 years): Baseline mean LDL-C must be >160 and <250 mg/dl as determined by the arithmetic mean of measures taken at visit 1 and 2. Fasting mean TGs should be <400 mg/dl.
- For subjects with 2 or more risk factors (cigarette smoking, hypertension (BP > 140/90 or on antihypertensive medication), low HDL (<40mg/dl), family history of premature CHD (CHD in male first degree relative <55 years; CHD in female first degree relative <65 years), age (men> 45 years; women > 55 years) or prior stable CHD: Baseline mean LDL-C must be >130 and <250 mg/dl as determined by the arithmetic mean of measures taken at visit 1 and 2. Fasting mean TGs should be <400 mg/dl.
- Able to understand and willing to comply with all study requirements, particularly the study drug regimen.
- Able to understand and willing to sign the Informed Consent Form.
Key exclusion criteria (14 listed)
- Women who are pregnant or lactating or who are planning to become pregnant or women of child bearing potential who have not successfully been using acceptable contraceptive methods over the previous 3 months (e.g. intrauterine device and barrier method plus spermicide).
- Uncontrolled hypertension defined as: systolic blood pressure > 180 mmHg, diastolic blood pressure > 95 mmHg
- History of chronic renal insufficiency (serum creatinine >2.5 mg/dL)
- History of liver disease or transaminases above 1.5 X ULN at screening
- Any major surgical procedure occurring less than 3 months prior to the screening visit
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-201038 (AEGR-733) | Drug | – |
| Ezetimibe | Drug | – |
Primary outcome
Percent Change in LDL-C at 12 Weeks Therapy Compared to Baseline Between Treatments
Time frame: Baseline and 12 weeks of treatment
9 secondary outcomes
Percent of Change at 12 Weeks Therapy Compared to Baseline Between Treatments for the Following Parameters: Total Cholesterol (TC)
Time frame: Baseline and 12 weeks of treatment
Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at 12 Weeks as Compared to Baseline.
Time frame: Baseline and 12 weeks of treatment
Percent Change in Tryglycerides (TGs) at 12 Weeks Compared to Baseline
Time frame: Baseline and 12 weeks of treatment
Percent Change in HDL-C at 12 Weeks Compared to Baseline
Time frame: Baseline and 12 weeks of treatment
Percent Change in Lipoprotein(a)[Lp(a)]at 12 Weeks as Compared to Baseline
Time frame: Baseline and 12 weeks of treatment
Percent Change in Apolipoprotein A1 (Apo A1) at 12 Weeks as Compared to Baseline
Time frame: baseline and 12 weeks of treatment
Percent Change in Apolipoprotein B (Apo B) at 12 Weeks as Compared to Baseline
Time frame: Baseline and 12 weeks of treatment
Percent Change in High-sensitivity C-reactive Protein (Hs-CRP) at 12 Weeks as Compared to Baseline
Time frame: Baseline and 12 weeks of treatment
Percent Change in Body Weight at 12 Weeks as Compared to Baseline
Time frame: Baseline and 12 weeks of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Michael Davidson, MD principal investigator
Radiant Research
Jackson Downey, MD principal investigator
Jacksonville Center For Clinical Research
Paul Grena, MD principal investigator
Cardiology Consultants of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BMS-201038 (AEGR-733) and Ezetimibe in people with Hypercholesterolemia, run by Aegerion Pharmaceuticals, Inc. at 1 site in United States.
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 5 inclusion and 14 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 4 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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. 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?
Yes. Results are posted in the registry (first posted 4 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change in LDL-C at 12 Weeks Therapy Compared to Baseline Between Treatments (time frame: Baseline and 12 weeks of treatment). 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 4 Mar 2014.