HypercholesterolemiaPhase 2NCT00690443
Evaluate Safety and Efficacy of AEGR-733 and Atorvastatin vs Atorvastatin Monotherapy in Hypercholesterolemia
A Phase 2 study testing Atorvastatin and AEGR-733 in people with Hypercholesterolemia, run by Aegerion Pharmaceuticals, Inc. at 5 sites in United States.
Trial summary
Evaluate the efficacy of combination therapy AEGR-733 plus atorvastatin 20 mg versus monotherapy on serum lipoproteins over 4 and 8 weeks of therapy. The primary efficacy parameter is percent change in LDL-C after 8 weeks of therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Atorvastatin and AEGR-733
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 5 sitesUnited States
- Study dates
- May 2008to Sep 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- M/F 18-70
- 0-1 risk factor, mean LDL-C -/> 160 and -/< 250 mg/dL (Visit 2 \& 3)
- 2+ risk factors, mean LDL-C -/> 130 \& -/< 250 mg/dL (Visit 2 \& 3)
- Fasting mean TGs -/< 400 mg/dL
- Understanding and compliance of protocol
- sign consent
Who cannot join
- Females pregnant, lactating, or CBP who have not been using acceptable contraceptive methods over previous 3 months
- Uncontrolled hypertension >180/95 at screening
- Hx of chronic renal insufficiency (serum creatinine > 2.5 mg/dL)
- Hx of liver disease or transaminases > 1.5 X ULN
- Positive for Hepatitis B or C
- Major surgery within past 3 mos
Show all 19Show fewer
- Cardiac insufficiency defined as functional Class II-Class IV
- Hx of malignancy within previous 5 years
- Participation in another investigational drug study within past 6 wks
- Serious or unstable medical or psychological condition
- Regular alcohol use > 1 drink per day
- Regular consumers of grapefruit juice or medications known to be metabolized by CYP 3A4
- Use of other lipid-lowering meds (washout permitted)
- Acute CVD
- Diabetes Mellitus
- Fasting glucose >110 mg/dL
- BMI -/> 40 kg/m2
- Significant gastrointestinal symptoms such as IBS
- Use of fish oils, niacin, herbal wt. loss products (washout permitted)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Michele Reynolds, MD
Dallas, Texas, 75231
Sheila Rodstein, MD
Edina, Minnesota, 55435
Dennis McCluskey, MD - Radiant Research
Mogadore, Ohio, 44260
Linda Murray, DO - Radiant Research
Pinellas Park, Florida, 33781
William Jennings, MD - Radiant Research
San Antonio, Texas, 78229
About this study
Official title: A Randomized, Double Blind Comparator-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of the Combination of AEGR-733 and Atorvastatin 20 mg vs Atorvastatin Monotherapy in Subjects With Moderate Hypercholesterolemia
Evaluate the efficacy of combination therapy AEGR-733 plus atorvastatin 20 mg versus monotherapy on serum lipoproteins over 4 and 8 weeks of therapy. The primary efficacy parameter is percent change in LDL-C after 8 weeks of therapy.
Read the detailed description
Following a 35-day washout of current lipid-lowering medication (if any) and adherence to a low-fat diet, subjects will receive either atorvastatin 20 mg for 8 weeks, OR AEGR-733 2.5 mg + atorvastatin 20 mg for 4 weeks followed by AEGR-733 5 mg + atorvastatin 20 mg for 4 additional weeks. During the entire study, subjects will be instructed to follow a low-fat/low cholesterol diet and limit alcohol consumption to -/< 1 drink per day.
- Conditions
- Hypercholesterolemia
- Being tested
- Atorvastatin, AEGR-733
- Keywords
- Hyperlipidemia
- Medical subject headings
- Hypercholesterolemia, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Also called Lipitor
atorvastatin 20 mg tablets, daily dosing, for 8 weeks.
AEGR-733Drug
2.5 mg AEGR-733 capsules, daily dosing, 4 weeks followed by 5 mg AEGR-733 capsules, daily dosing, 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | 2.5 mg AEGR 733 plus atorvastatin 20 mg weeks 1-4 followed by 5 mg AEGR 733 plus atorvastatin 20 mg weeks 5-8 Receives: Drug: AEGR-733 |
| 1 | Active comparator | Following 35-day washout + diet run-in, subjects receive atorvastatin 20 mg for 8 wks. Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in LDL-C After 8 Weeks of Therapy
Measured: Baseline and 8 weeks of treatment
Secondary outcomes (1)
Percent Changes in LDL-C at Week 4 + Baseline Serum Lipoproteins (TC, Non-HDL, VLDL, TGs, HDL-C, Apolopoproteins A1 and B), High Sensitivity C-reactive Protein and Change in Body Weight.
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionSep 2008
- Study completionSep 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.
- 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aegerion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Belknap, MD, Study director, Medical Monitor at Radiant Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00690443
- Sponsor's protocol ID
- AEGR-733-006
- Status last verified
- Feb 2018
- First submitted
- 20 May 2008
- Last updated
- 23 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind Comparator-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of the Combination of AEGR-733 and Atorvastatin 20 mg vs Atorvastatin Monotherapy in Subjects With Moderate Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT00690443
- Acronym / sponsor ID
- AEGR-733-006
- Conditions
- Hypercholesterolemia
- Keywords
- Hyperlipidemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Aegerion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 4 Jun 2008 (estimated)
- Results
- Posted 25 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the efficacy of combination therapy AEGR-733 plus atorvastatin 20 mg versus monotherapy on serum lipoproteins over 4 and 8 weeks of therapy. The primary efficacy parameter is percent change in LDL-C after 8 weeks of therapy.
Detailed description
Following a 35-day washout of current lipid-lowering medication (if any) and adherence to a low-fat diet, subjects will receive either atorvastatin 20 mg for 8 weeks, OR AEGR-733 2.5 mg + atorvastatin 20 mg for 4 weeks followed by AEGR-733 5 mg + atorvastatin 20 mg for 4 additional weeks. During the entire study, subjects will be instructed to follow a low-fat/low cholesterol diet and limit alcohol consumption to -/< 1 drink per day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Drug: AEGR-7332.5 mg AEGR 733 plus atorvastatin 20 mg weeks 1-4 followed by 5 mg AEGR 733 plus atorvastatin 20 mg weeks 5-8 |
| 1 | Active comparator | Drug: AtorvastatinFollowing 35-day washout + diet run-in, subjects receive atorvastatin 20 mg for 8 wks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- M/F 18-70
- 0-1 risk factor, mean LDL-C -/> 160 and -/< 250 mg/dL (Visit 2 \& 3)
- 2+ risk factors, mean LDL-C -/> 130 \& -/< 250 mg/dL (Visit 2 \& 3)
- Fasting mean TGs -/< 400 mg/dL
- Understanding and compliance of protocol
Key exclusion criteria (19 listed)
- Females pregnant, lactating, or CBP who have not been using acceptable contraceptive methods over previous 3 months
- Uncontrolled hypertension >180/95 at screening
- Hx of chronic renal insufficiency (serum creatinine > 2.5 mg/dL)
- Hx of liver disease or transaminases > 1.5 X ULN
- Positive for Hepatitis B or 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 |
|---|---|---|
| AtorvastatinAlso: Lipitoratorvastatin 20 mg tablets, daily dosing, for 8 weeks. | Drug | 1 |
| AEGR-7332.5 mg AEGR-733 capsules, daily dosing, 4 weeks followed by 5 mg AEGR-733 capsules, daily dosing, 4 weeks | Drug | 2 |
Primary outcome
Percent Change in LDL-C After 8 Weeks of Therapy
Time frame: Baseline and 8 weeks of treatment
1 secondary outcome
Percent Changes in LDL-C at Week 4 + Baseline Serum Lipoproteins (TC, Non-HDL, VLDL, TGs, HDL-C, Apolopoproteins A1 and B), High Sensitivity C-reactive Protein and Change in Body Weight.
Time frame: Baseline and 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
- 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.
Steven Belknap, MD study director
Medical Monitor at Radiant Research
5 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 and AEGR-733 in people with Hypercholesterolemia, run by Aegerion Pharmaceuticals, Inc. at 5 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 6 inclusion and 19 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 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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. 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 25 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 in LDL-C After 8 Weeks of Therapy (time frame: Baseline and 8 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 23 Feb 2018.