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AEGR-733 and Atorvastatin 20 mg vs. Monotherapy in Moderate Hypercholesterolemia

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Atorvastatin 20 mg
AEGR-733 5 mg
AEGR-733 10 mg
Placebo
AEGR-733 5 mg + atorvastatin 20 mg
AEGR-733 10 mg + atorvastatin 20 mg
Sponsored by
Aegerion Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring cholesterol

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Men and women between the ages of 18 and 70 years.
  2. Elevated LDL cholesterol based on risk factors for cardiovascular disease or presence of cardiovascular disease

Exclusion Criteria:

  1. Women who are pregnant, lactating, planning to become pregnant, or women of childbearing potential who have not successfully been using acceptable contraceptive methods over the previous 3 months, e.g., intrauterine device (IUD) and barrier method plus spermicide.
  2. Uncontrolled hypertension
  3. History of chronic kidney problems
  4. History of liver disease
  5. Positive for Hepatitis B or Hepatitis C.
  6. Any major surgical procedure occurring less than 3 months ago
  7. Cardiac insufficiency
  8. History of a malignant cancer (other than basal cell or squamous cell carcinoma of the skin that has been removed) within the previous 5 years.
  9. Regular alcohol use >1 drink per day.
  10. Regular consumers of grapefruit juice, or currently taking the following medications: cyclosporine, itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, and nefazodone.
  11. Use of other cholesterol lowering medications that cannot be stopped.
  12. Heart attack or stroke within the previous 6 months
  13. Diabetes Mellitus
  14. Body mass index (BMI) ≥ 40 kg/m2.
  15. Significant gastrointestinal symptoms, such as irritable bowel syndrome.
  16. Current use of fish oils, niacin, and herbal weight loss products that cannot be stopped.

Sites / Locations

  • Medical Affiliated Research Center
  • Jacksonville Center for Clinical research
  • Jacksonville Center For Clinical Research
  • Renstar Medical Research
  • North Georgia Clinical Research
  • Radiant Research
  • Medsphere Medical Research Center
  • Midwest Institute for Clinical Research
  • Maine Research Associates
  • Health Trends Research
  • Piedmont Medical Research Associates
  • Sterling Research Group
  • Coastal Carolina Research Center
  • Dallas Diabetes and Endocrine Center
  • Diabetes and Glandular Disease Research
  • Hampton Roads Center for Clinical Research
  • National Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Active Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

5

6

Arm Description

Outcomes

Primary Outcome Measures

Percent Change From Baseline in LDL-C at 8 Weeks

Secondary Outcome Measures

Percent Change From Baseline of Other Lipids

Full Information

First Posted
May 14, 2007
Last Updated
February 21, 2018
Sponsor
Aegerion Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00474240
Brief Title
AEGR-733 and Atorvastatin 20 mg vs. Monotherapy in Moderate Hypercholesterolemia
Official Title
A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety and Efficacy of the Combination of AEGR-733 (Formerly BMS201038) and Atorvastatin 20 mg vs. Monotherapy in Subjects With Moderate Hypercholesterolemia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 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
The purpose of this study is to test the effectiveness of the study drug, AEGR-733 alone and in combination with the medication, atorvastatin (Lipitor), on cholesterol in volunteers with moderately high cholesterol.
Detailed Description
Recent studies suggest more intensive cholesterol lowering treatment for people at very high risk of a heart attack, specifically for patients who have heart disease plus major risk factors. Available medications used alone at even the highest approved doses are not expected to reach these new target recommendations for cholesterol in a large number of subjects. Thus, the development of new medications that can provide additional cholesterol lowering may be beneficial. This study tests the effectiveness of different doses of the study drug, AEGR-733 alone and in combination with the approved cholesterol lowering drug, atorvastatin (Lipitor), on cholesterol. Volunteers will be randomized to one of 6 different study treatments and will take the assigned medication (3 capsules daily) for 8 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
cholesterol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
157 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Title
2
Arm Type
Active Comparator
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Experimental
Arm Title
5
Arm Type
Experimental
Arm Title
6
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Atorvastatin 20 mg
Intervention Type
Drug
Intervention Name(s)
AEGR-733 5 mg
Intervention Type
Drug
Intervention Name(s)
AEGR-733 10 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
AEGR-733 5 mg + atorvastatin 20 mg
Intervention Type
Drug
Intervention Name(s)
AEGR-733 10 mg + atorvastatin 20 mg
Primary Outcome Measure Information:
Title
Percent Change From Baseline in LDL-C at 8 Weeks
Time Frame
Atfer 8 weeks on study drug
Secondary Outcome Measure Information:
Title
Percent Change From Baseline of Other Lipids
Time Frame
After 8 weeks of study drug

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women between the ages of 18 and 70 years. Elevated LDL cholesterol based on risk factors for cardiovascular disease or presence of cardiovascular disease Exclusion Criteria: Women who are pregnant, lactating, planning to become pregnant, or women of childbearing potential who have not successfully been using acceptable contraceptive methods over the previous 3 months, e.g., intrauterine device (IUD) and barrier method plus spermicide. Uncontrolled hypertension History of chronic kidney problems History of liver disease Positive for Hepatitis B or Hepatitis C. Any major surgical procedure occurring less than 3 months ago Cardiac insufficiency History of a malignant cancer (other than basal cell or squamous cell carcinoma of the skin that has been removed) within the previous 5 years. Regular alcohol use >1 drink per day. Regular consumers of grapefruit juice, or currently taking the following medications: cyclosporine, itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, and nefazodone. Use of other cholesterol lowering medications that cannot be stopped. Heart attack or stroke within the previous 6 months Diabetes Mellitus Body mass index (BMI) ≥ 40 kg/m2. Significant gastrointestinal symptoms, such as irritable bowel syndrome. Current use of fish oils, niacin, and herbal weight loss products that cannot be stopped.
Facility Information:
Facility Name
Medical Affiliated Research Center
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Jacksonville Center for Clinical research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32205
Country
United States
Facility Name
Jacksonville Center For Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
North Georgia Clinical Research
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
Facility Name
Radiant Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
Medsphere Medical Research Center
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Midwest Institute for Clinical Research
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Maine Research Associates
City
Auburn
State/Province
Maine
ZIP/Postal Code
04210
Country
United States
Facility Name
Health Trends Research
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21209
Country
United States
Facility Name
Piedmont Medical Research Associates
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Sterling Research Group
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45246
Country
United States
Facility Name
Coastal Carolina Research Center
City
Goose Creek
State/Province
South Carolina
ZIP/Postal Code
29445
Country
United States
Facility Name
Dallas Diabetes and Endocrine Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Diabetes and Glandular Disease Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Hampton Roads Center for Clinical Research
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
National Clinical Research
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17215532
Citation
Cuchel M, Bloedon LT, Szapary PO, Kolansky DM, Wolfe ML, Sarkis A, Millar JS, Ikewaki K, Siegelman ES, Gregg RE, Rader DJ. Inhibition of microsomal triglyceride transfer protein in familial hypercholesterolemia. N Engl J Med. 2007 Jan 11;356(2):148-56. doi: 10.1056/NEJMoa061189.
Results Reference
background

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AEGR-733 and Atorvastatin 20 mg vs. Monotherapy in Moderate Hypercholesterolemia

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