HypercholesterolemiaPhase 2NCT00474240
AEGR-733 and Atorvastatin 20 mg vs. Monotherapy in Moderate Hypercholesterolemia
A Phase 2 study testing Atorvastatin 20 mg, AEGR-733 5 mg and AEGR-733 10 mg in people with Hypercholesterolemia, run by Aegerion Pharmaceuticals, Inc. at 17 sites in United States.
Trial summary
The purpose of this study is to test the effectiveness of the study drug, AEGR-733 alone and in combination with the medication, atorvastatin (Lipitor), on cholesterol in volunteers with moderately high cholesterol. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Atorvastatin 20 mg, AEGR-733 5 mg and AEGR-733 10 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 157 participants
- Where
- 17 sitesUnited States
- Study dates
- Apr 2007to Oct 2008
- 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.
- Elevated LDL cholesterol based on risk factors for cardiovascular disease or presence of cardiovascular disease
Who cannot join
- Women who are pregnant, lactating, planning to become pregnant, or women of childbearing potential who have not successfully been using acceptable contraceptive methods over the previous 3 months, e.g., intrauterine device (IUD) and barrier method plus spermicide.
- Uncontrolled hypertension
- History of chronic kidney problems
- History of liver disease
- Positive for Hepatitis B or Hepatitis C.
- Any major surgical procedure occurring less than 3 months ago
Show all 16Show fewer
- Cardiac insufficiency
- History of a malignant cancer (other than basal cell or squamous cell carcinoma of the skin that has been removed) within the previous 5 years.
- Regular alcohol use >1 drink per day.
- Regular consumers of grapefruit juice, or currently taking the following medications: cyclosporine, itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, and nefazodone.
- Use of other cholesterol lowering medications that cannot be stopped.
- Heart attack or stroke within the previous 6 months
- Diabetes Mellitus
- Body mass index (BMI) ≥ 40 kg/m2.
- Significant gastrointestinal symptoms, such as irritable bowel syndrome.
- Current use of fish oils, niacin, and herbal weight loss products that cannot be stopped.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Maine Research Associates
Auburn, Maine, 04210
Health Trends Research
Baltimore, Maryland, 21209
Radiant Research
Chicago, Illinois, 60610
Sterling Research Group
Cincinnati, Ohio, 45246
Dallas Diabetes and Endocrine Center
Dallas, Texas, 75230
Diabetes and Glandular Disease Research
Dallas, Texas, 78229
Medsphere Medical Research Center
Evansville, Indiana, 47714
Coastal Carolina Research Center
Goose Creek, South Carolina, 29445
Medical Affiliated Research Center
Huntsville, Alabama, 35801
Midwest Institute for Clinical Research
Indianapolis, Indiana, 46260
Jacksonville Center for Clinical research
Jacksonville, Florida, 32205
Jacksonville Center For Clinical Research
Jacksonville, Florida, 32216
Hampton Roads Center for Clinical Research
Norfolk, Virginia, 23502
Renstar Medical Research
Ocala, Florida, 34471
National Clinical Research
Richmond, Virginia, 23294
Piedmont Medical Research Associates
Winston-Salem, North Carolina, 27103
North Georgia Clinical Research
Woodstock, Georgia, 30189
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety and Efficacy of the Combination of AEGR-733 (Formerly BMS201038) and Atorvastatin 20 mg vs. Monotherapy in Subjects With Moderate Hypercholesterolemia
The purpose of this study is to test the effectiveness of the study drug, AEGR-733 alone and in combination with the medication, atorvastatin (Lipitor), on cholesterol in volunteers with moderately high cholesterol.
Read the detailed description
Recent studies suggest more intensive cholesterol lowering treatment for people at very high risk of a heart attack, specifically for patients who have heart disease plus major risk factors. Available medications used alone at even the highest approved doses are not expected to reach these new target recommendations for cholesterol in a large number of subjects. Thus, the development of new medications that can provide additional cholesterol lowering may be beneficial.
This study tests the effectiveness of different doses of the study drug, AEGR-733 alone and in combination with the approved cholesterol lowering drug, atorvastatin (Lipitor), on cholesterol. Volunteers will be randomized to one of 6 different study treatments and will take the assigned medication (3 capsules daily) for 8 weeks.
- Conditions
- Hypercholesterolemia
- Being tested
- Atorvastatin 20 mg, AEGR-733 5 mg, AEGR-733 10 mg, Placebo, AEGR-733 5 mg + atorvastatin 20 mg
- 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.
Atorvastatin 20 mgDrug
AEGR-733 5 mgDrug
AEGR-733 10 mgDrug
PlaceboDrug
AEGR-733 5 mg + atorvastatin 20 mgDrug
AEGR-733 10 mg + atorvastatin 20 mgDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: Placebo |
| 2 | Active comparator | Not described Receives: Drug: Atorvastatin 20 mg |
| 3 | Experimental | Not described Receives: Drug: AEGR-733 5 mg |
| 4 | Experimental | Not described Receives: Drug: AEGR-733 10 mg |
| 5 | Experimental | Not described Receives: Drug: AEGR-733 5 mg + atorvastatin 20 mg |
| 6 | Experimental | Not described Receives: Drug: AEGR-733 10 mg + atorvastatin 20 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in LDL-C at 8 Weeks
Measured: Atfer 8 weeks on study drug
Secondary outcomes (1)
Percent Change From Baseline of Other Lipids
Measured: After 8 weeks of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2007 (estimated)
- Study startApr 2007
- Primary completionOct 2008
- Study completionOct 2008
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aegerion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00474240
- Sponsor's protocol ID
- AEGR-733-003
- Status last verified
- Jan 2013
- First submitted
- 14 May 2007
- Last updated
- 20 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Cuchel M, Bloedon LT, Szapary PO, Kolansky DM, Wolfe ML, Sarkis A, Millar JS, Ikewaki K, Siegelman ES, Gregg RE, Rader DJ. Inhibition of microsomal triglyceride transfer protein in familial hypercholesterolemia. N Engl J Med. 2007 Jan 11;356(2):148-56. doi: 10.1056/NEJMoa061189.
PubMed 17215532
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety and Efficacy of the Combination of AEGR-733 (Formerly BMS201038) and Atorvastatin 20 mg vs. Monotherapy in Subjects With Moderate Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT00474240
- Acronym / sponsor ID
- AEGR-733-003
- Conditions
- Hypercholesterolemia
- Keywords
- cholesterol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Aegerion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 16 May 2007 (estimated)
- Results
- Posted 21 Feb 2013
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 test the effectiveness of the study drug, AEGR-733 alone and in combination with the medication, atorvastatin (Lipitor), on cholesterol in volunteers with moderately high cholesterol.
Detailed description
Recent studies suggest more intensive cholesterol lowering treatment for people at very high risk of a heart attack, specifically for patients who have heart disease plus major risk factors. Available medications used alone at even the highest approved doses are not expected to reach these new target recommendations for cholesterol in a large number of subjects. Thus, the development of new medications that can provide additional cholesterol lowering may be beneficial.
This study tests the effectiveness of different doses of the study drug, AEGR-733 alone and in combination with the approved cholesterol lowering drug, atorvastatin (Lipitor), on cholesterol. Volunteers will be randomized to one of 6 different study treatments and will take the assigned medication (3 capsules daily) for 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Placebo |
| 2 | Active comparator | Drug: Atorvastatin 20 mg |
| 3 | Experimental | Drug: AEGR-733 5 mg |
| 4 | Experimental | Drug: AEGR-733 10 mg |
| 5 | Experimental | Drug: AEGR-733 5 mg + atorvastatin 20 mg |
| 6 | Experimental | Drug: AEGR-733 10 mg + atorvastatin 20 mg |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women between the ages of 18 and 70 years.
- Elevated LDL cholesterol based on risk factors for cardiovascular disease or presence of cardiovascular disease
Key exclusion criteria (16 listed)
- Women who are pregnant, lactating, planning to become pregnant, or women of childbearing potential who have not successfully been using acceptable contraceptive methods over the previous 3 months, e.g., intrauterine device (IUD) and barrier method plus spermicide.
- Uncontrolled hypertension
- History of chronic kidney problems
- History of liver disease
- Positive for Hepatitis B or Hepatitis C.
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 |
|---|---|---|
| Atorvastatin 20 mg | Drug | 2 |
| AEGR-733 5 mg | Drug | 3 |
| AEGR-733 10 mg | Drug | 4 |
| Placebo | Drug | 1 |
| AEGR-733 5 mg + atorvastatin 20 mg | Drug | 5 |
| AEGR-733 10 mg + atorvastatin 20 mg | Drug | 6 |
Primary outcome
Percent Change From Baseline in LDL-C at 8 Weeks
Time frame: Atfer 8 weeks on study drug
1 secondary outcome
Percent Change From Baseline of Other Lipids
Time frame: After 8 weeks of study drug
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17215532Cuchel M, Bloedon LT, Szapary PO, Kolansky DM, Wolfe ML, Sarkis A, Millar JS, Ikewaki K, Siegelman ES, Gregg RE, Rader DJ. Inhibition of microsomal triglyceride transfer protein in familial hypercholesterolemia. N Engl J Med. 2007 Jan 11;356(2):148-56. doi: 10.1056/NEJMoa061189.
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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.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atorvastatin 20 mg, AEGR-733 5 mg and AEGR-733 10 mg in people with Hypercholesterolemia, run by Aegerion Pharmaceuticals, Inc. at 17 sites 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 2 inclusion and 16 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 20 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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. 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?
Yes. Results are posted in the registry (first posted 21 Feb 2013). 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 From Baseline in LDL-C at 8 Weeks (time frame: Atfer 8 weeks on study drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00474240, which also lists 1 linked publication.
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 20 Mar 2018; AzTrials last refreshed its copy on 7 Nov 2026.