Phase 2
Completed N=157
AEGR-733 and Atorvastatin 20 mg vs. Monotherapy in Moderate Hypercholesterolemia
Source: ClinicalTrials.gov NCT00474240 ↗Enrolled (actual)
157
Serious AEs
1.3%
Results posted
Feb 2013
Primary outcomePrimary: Percent Change From Baseline in LDL-C at 8 Weeks — 2; -42; -16; -37 Percent Change
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in LDL-C at 8 Weeks |
2; -42; -16; -37; -47; -50 | — |
| SECONDARY Percent Change From Baseline of Other Lipids |
2; -30; -18; -33; -37; -40 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- 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.
Data sourced from ClinicalTrials.gov (NCT00474240). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.