Phase 2
Completed N=85
The Safety & Efficacy of Combination BMS-201038 (AEGR-733) & Ezetimibe vs. Monotherapy in Moderate Hypercholesterolemia
Source: ClinicalTrials.gov NCT00405067 ↗Enrolled (actual)
85
Serious AEs
1.2%
Results posted
Mar 2014
Primary outcomePrimary: Percent Change in LDL-C at 12 Weeks Therapy Compared to Baseline Between Treatments — -46.2; -29.9; -19.6 Percent Change
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in LDL-C at 12 Weeks Therapy Compared to Baseline Between Treatments |
-46.2; -29.9; -19.6 | — |
| SECONDARY Percent of Change at 12 Weeks Therapy Compared to Baseline Between Treatments for the Following Parameters: Total Cholesterol (TC) |
-34.4; -22.8; -12.0 | — |
| SECONDARY Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at 12 Weeks as Compared to Baseline. |
-41.3; -26.9; -17.0 | — |
| SECONDARY Percent Change in Tryglycerides (TGs) at 12 Weeks Compared to Baseline |
-7.0; -5.8; 2.7 | — |
| SECONDARY Percent Change in HDL-C at 12 Weeks Compared to Baseline |
-9.2; -6.2; 5.9 | — |
| SECONDARY Percent Change in Lipoprotein(a)[Lp(a)]at 12 Weeks as Compared to Baseline |
-12.0; -11.4; 7.5 | — |
| SECONDARY Percent Change in Apolipoprotein A1 (Apo A1) at 12 Weeks as Compared to Baseline |
-10.7; -8.0; 2.3 | — |
| SECONDARY Percent Change in Apolipoprotein B (Apo B) at 12 Weeks as Compared to Baseline |
-36.6; -23.7; -14.5 | — |
| SECONDARY Percent Change in High-sensitivity C-reactive Protein (Hs-CRP) at 12 Weeks as Compared to Baseline |
40.4; 81.3; 233.3 | — |
| SECONDARY Percent Change in Body Weight at 12 Weeks as Compared to Baseline |
-1.4; -1.0; -0.1 | — |
Eligibility Criteria
Inclusion Criteria
- 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 ( 45 years; women > 55 years): Baseline mean LDL-C must be >160 and 140/90 or on antihypertensive medication), low HDL ( 45 years; women > 55 years) or prior stable CHD: Baseline mean LDL-C must be >130 and 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
- 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
Data sourced from ClinicalTrials.gov (NCT00405067). 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.