Evaluate Safety and Efficacy of AEGR-733 and Atorvastatin vs Atorvastatin Monotherapy in Hypercholesterolemia
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ClinicalTrials.gov Identifier: NCT00690443 |
Recruitment Status
:
Completed
First Posted
: June 4, 2008
Results First Posted
: February 25, 2013
Last Update Posted
: February 23, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypercholesterolemia | Drug: Atorvastatin Drug: AEGR-733 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 44 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | May 2008 |
Actual Primary Completion Date : | September 2008 |
Actual Study Completion Date : | September 2008 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 2
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
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Drug: AEGR-733
2.5 mg AEGR-733 capsules, daily dosing, 4 weeks followed by 5 mg AEGR-733 capsules, daily dosing, 4 weeks
|
Active Comparator: 1
Following 35-day washout + diet run-in, subjects receive atorvastatin 20 mg for 8 wks.
|
Drug: Atorvastatin
atorvastatin 20 mg tablets, daily dosing, for 8 weeks.
Other Name: Lipitor
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- Percent Change in LDL-C After 8 Weeks of Therapy [ Time Frame: Baseline and 8 weeks of treatment ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00690443
United States, Florida | |
Linda Murray, DO - Radiant Research | |
Pinellas Park, Florida, United States, 33781 | |
United States, Minnesota | |
Sheila Rodstein, MD | |
Edina, Minnesota, United States, 55435 | |
United States, Ohio | |
Dennis McCluskey, MD - Radiant Research | |
Mogadore, Ohio, United States, 44260 | |
United States, Texas | |
Michele Reynolds, MD | |
Dallas, Texas, United States, 75231 | |
William Jennings, MD - Radiant Research | |
San Antonio, Texas, United States, 78229 |
Study Director: | Steven Belknap, MD | Medical Monitor at Radiant Research |
Responsible Party: | Aegerion Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00690443 History of Changes |
Other Study ID Numbers: |
AEGR-733-006 |
First Posted: | June 4, 2008 Key Record Dates |
Results First Posted: | February 25, 2013 |
Last Update Posted: | February 23, 2018 |
Last Verified: | February 2018 |
Keywords provided by Aegerion Pharmaceuticals, Inc.:
Hyperlipidemia |
Additional relevant MeSH terms:
Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Atorvastatin Calcium Anticholesteremic Agents |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |