Phase 2 Completed N=44 Randomized Triple-blind Treatment

Evaluate Safety and Efficacy of AEGR-733 and Atorvastatin vs Atorvastatin Monotherapy in Hypercholesterolemia

Hypercholesterolemia

Source: ClinicalTrials.gov NCT00690443 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2013

Primary outcomePrimary: Percent Change in LDL-C After 8 Weeks of Therapy — -39.6; -49.9 Percent Change

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change in LDL-C After 8 Weeks of Therapy	-39.6; -49.9	—
SECONDARY 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.	-42.5; -51.0; -31.3; -38.1; -21.5; -17.8	—

Eligibility Criteria

Inclusion Criteria

M/F 18-70
0-1 risk factor, mean LDL-C -/> 160 and -/ 130 & -/ 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)

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Data sourced from ClinicalTrials.gov (NCT00690443). 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.