Back to resultsEvaluate Safety and Efficacy of AEGR-733 and Atorvastatin vs Atorvastatin Monotherapy in Hypercholesterolemia
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Atorvastatin
AEGR-733
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia focused on measuring Hyperlipidemia
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)
Sites / Locations
- Linda Murray, DO - Radiant Research
- Sheila Rodstein, MD
- Dennis McCluskey, MD - Radiant Research
- Michele Reynolds, MD
- William Jennings, MD - Radiant Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
2
1
Arm Description
2.5 mg AEGR 733 plus atorvastatin 20 mg weeks 1-4 followed by 5 mg AEGR 733 plus atorvastatin 20 mg weeks 5-8
Following 35-day washout + diet run-in, subjects receive atorvastatin 20 mg for 8 wks.
Outcomes
Primary Outcome Measures
Percent Change in LDL-C After 8 Weeks of Therapy
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00690443
First Posted
May 20, 2008
Last Updated
February 21, 2018
Sponsor
Aegerion Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00690443
Brief Title
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
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aegerion Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
Hyperlipidemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Active Comparator
Arm Description
2.5 mg AEGR 733 plus atorvastatin 20 mg weeks 1-4 followed by 5 mg AEGR 733 plus atorvastatin 20 mg weeks 5-8
Arm Title
1
Arm Type
Active Comparator
Arm Description
Following 35-day washout + diet run-in, subjects receive atorvastatin 20 mg for 8 wks.
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Other Intervention Name(s)
Lipitor
Intervention Description
atorvastatin 20 mg tablets, daily dosing, for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
AEGR-733
Intervention Description
2.5 mg AEGR-733 capsules, daily dosing, 4 weeks followed by 5 mg AEGR-733 capsules, daily dosing, 4 weeks
Primary Outcome Measure Information:
Title
Percent Change in LDL-C After 8 Weeks of Therapy
Time Frame
Baseline and 8 weeks of treatment
Secondary Outcome Measure Information:
Title
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.
Time Frame
Baseline and 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Belknap, MD
Organizational Affiliation
Medical Monitor at Radiant Research
Official's Role
Study Director
Facility Information:
Facility Name
Linda Murray, DO - Radiant Research
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Sheila Rodstein, MD
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Dennis McCluskey, MD - Radiant Research
City
Mogadore
State/Province
Ohio
ZIP/Postal Code
44260
Country
United States
Facility Name
Michele Reynolds, MD
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
William Jennings, MD - Radiant Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluate Safety and Efficacy of AEGR-733 and Atorvastatin vs Atorvastatin Monotherapy in Hypercholesterolemia
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