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

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ClinicalTrials.gov Identifier: NCT00690443
Recruitment Status : Completed
First Posted : June 4, 2008
Results First Posted : February 25, 2013
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
Aegerion Pharmaceuticals, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: Atorvastatin Drug: AEGR-733 Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : May 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 2
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
 Drug: AEGR-733
2.5 mg AEGR-733 capsules, daily dosing, 4 weeks followed by 5 mg AEGR-733 capsules, daily dosing, 4 weeks
Active Comparator: 1
Following 35-day washout + diet run-in, subjects receive atorvastatin 20 mg for 8 wks.
 Drug: Atorvastatin
atorvastatin 20 mg tablets, daily dosing, for 8 weeks.
Other Name: Lipitor


Outcome Measures
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Primary Outcome Measures :
  1. Percent Change in LDL-C After 8 Weeks of Therapy [ Time Frame: Baseline and 8 weeks of treatment ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00690443


Locations
United States, Florida
Linda Murray, DO - Radiant Research
Pinellas Park, Florida, United States, 33781
United States, Minnesota
Sheila Rodstein, MD
Edina, Minnesota, United States, 55435
United States, Ohio
Dennis McCluskey, MD - Radiant Research
Mogadore, Ohio, United States, 44260
United States, Texas
Michele Reynolds, MD
Dallas, Texas, United States, 75231
William Jennings, MD - Radiant Research
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Aegerion Pharmaceuticals, Inc.
Investigators
Study Director: Steven Belknap, MD Medical Monitor at Radiant Research
More Information
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Responsible Party: Aegerion Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00690443     History of Changes
Other Study ID Numbers: AEGR-733-006
First Posted: June 4, 2008    Key Record Dates
Results First Posted: February 25, 2013
Last Update Posted: February 23, 2018
Last Verified: February 2018

Keywords provided by Aegerion Pharmaceuticals, Inc.:
Hyperlipidemia

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin Calcium
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors