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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aegerion Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00690443
First received: May 20, 2008
Last updated: April 4, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention Phase
Hypercholesterolemia
 Drug: Atorvastatin
Drug: AEGR-733
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

Further study details as provided by Aegerion Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Percent Change in LDL-C After 8 Weeks of Therapy [ Time Frame: Baseline and 8 weeks of treatment ] [ Designated as safety issue: Yes ]

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. [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 44
Study Start Date: May 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Aegerion Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00690443     History of Changes
Other Study ID Numbers: AEGR 733-006
Study First Received: May 20, 2008
Results First Received: January 18, 2013
Last Updated: April 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Aegerion Pharmaceuticals, Inc.:
Hyperlipidemia

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

ClinicalTrials.gov processed this record on May 19, 2013