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

Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00690443
• Other study ID #: AEGR-733-006
• Status: Completed
• Phase: Phase 2
• First received: May 20, 2008
• Last updated: February 21, 2018
• Start date: May 2008
• Est. completion date: September 2008

Study information

• Verified date: February 2018
• Source: Aegerion Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• Atorvastatin
atorvastatin 20 mg tablets, daily dosing, for 8 weeks.
• AEGR-733
2.5 mg AEGR-733 capsules, daily dosing, 4 weeks followed by 5 mg AEGR-733 capsules, daily dosing, 4 weeks

Locations

Country	Name	City	State
United States	Michele Reynolds, MD	Dallas	Texas
United States	Sheila Rodstein, MD	Edina	Minnesota
United States	Dennis McCluskey, MD - Radiant Research	Mogadore	Ohio
United States	Linda Murray, DO - Radiant Research	Pinellas Park	Florida
United States	William Jennings, MD - Radiant Research	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Aegerion Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in LDL-C After 8 Weeks of Therapy		Baseline and 8 weeks of treatment
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.		Baseline and 4 weeks