Status:
COMPLETED
Evaluate Safety and Efficacy of AEGR-733 and Atorvastatin vs Atorvastatin Monotherapy in Hypercholesterolemia
Lead Sponsor:
Aegerion Pharmaceuticals, Inc.
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 i...
Detailed Description
Following a 35-day washout of current lipid-lowering medication (if any) and adherence to a low-fat diet, subjects will receive either atorvastatin 20 mg for 8 weeks, OR AEGR-733 2.5 mg + atorvastatin...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00690443
Start Date
May 1 2008
End Date
September 1 2008
Last Update
February 23 2018
Active Locations (5)
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1
Linda Murray, DO - Radiant Research
Pinellas Park, Florida, United States, 33781
2
Sheila Rodstein, MD
Edina, Minnesota, United States, 55435
3
Dennis McCluskey, MD - Radiant Research
Mogadore, Ohio, United States, 44260
4
Michele Reynolds, MD
Dallas, Texas, United States, 75231