Clinical trial NCT00690443: Evaluate Safety and Efficacy of AEGR-733 and Atorvastatin vs Atorvastatin Monotherapy in Hypercholesterolemia
Official title: A Randomized, Double Blind Comparator-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of the Combination of AEGR-733 and Atorvastatin 20 mg vs Atorvastatin Monotherapy in Subjects With Moderate Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypercholesterolemia
Keywords: Hyperlipidemia
Lead sponsor: Aegerion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2008-06-04
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 in LDL-C after 8 weeks of therapy.

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 20 mg for 4 weeks followed by AEGR-733 5 mg + atorvastatin 20 mg for 4 additional weeks. During the entire study, subjects will be instructed to follow a low-fat/low cholesterol diet and limit alcohol consumption to -/\< 1 drink per day.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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)

Primary outcomes:
measure: Percent Change in LDL-C After 8 Weeks of Therapy
timeFrame: Baseline and 8 weeks of treatment
Secondary outcomes:
measure: 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.
timeFrame: Baseline and 4 weeks
Other outcomes:
Locations:
city: Pinellas Park
country: United States
facility: Linda Murray, DO - Radiant Research
state: Florida
city: Edina
country: United States
facility: Sheila Rodstein, MD
state: Minnesota
city: Mogadore
country: United States
facility: Dennis McCluskey, MD - Radiant Research
state: Ohio
city: Dallas
country: United States
facility: Michele Reynolds, MD
state: Texas
city: San Antonio
country: United States
facility: William Jennings, MD - Radiant Research
state: Texas
Study officials:
affiliation: Medical Monitor at Radiant Research
name: Steven Belknap, MD
role: STUDY_DIRECTOR
References: