Evaluate Safety and Efficacy of AEGR-733 and Atorvastatin vs Atorvastatin Monotherapy in Hypercholesterolemia
Completed · Phase 2
Conditions studied: Hypercholesterolemia
In brief
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.
Key facts
- Study ID
- NCT00690443
- Run by
- Aegerion Pharmaceuticals, Inc.
- People needed
- 44
- Starts
- 2008-05-01
- Expected to finish
- 2008-09-01
- Last updated by the study team
- 2018-02-23
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Linda Murray, DO - Radiant Research — Pinellas Park, Florida, United States
- Sheila Rodstein, MD — Edina, Minnesota, United States
- Dennis McCluskey, MD - Radiant Research — Mogadore, Ohio, United States
- Michele Reynolds, MD — Dallas, Texas, United States
- William Jennings, MD - Radiant Research — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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