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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

May 20, 2008
April 4, 2013
May 2008
September 2008   (final data collection date for primary outcome measure)
Percent Change in LDL-C After 8 Weeks of Therapy [ Time Frame: Baseline and 8 weeks of treatment ] [ Designated as safety issue: Yes ]
Percent Change in LDL-C After 8 Weeks of Therapy [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00690443 on ClinicalTrials.gov Archive Site
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 ]
Percent changes in LDL-C at week 4 + baseline serum lipoproteins (TC, non-HDL, VLDL, TGs, HDL-C, apolipoproteins A1 and B), high sensitivity C-reactive protein, change in body weight,overall safety and tolerability. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Evaluate Safety and Efficacy of AEGR-733 and Atorvastatin vs Atorvastatin Monotherapy in Hypercholesterolemia
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Hypercholesterolemia
  • Drug: Atorvastatin
    atorvastatin 20 mg tablets, daily dosing, for 8 weeks.
    Other Name: Lipitor
  • 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: 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
    Intervention: Drug: AEGR-733
  • Active Comparator: 1
    Following 35-day washout + diet run-in, subjects receive atorvastatin 20 mg for 8 wks.
    Intervention: Drug: Atorvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
September 2008
September 2008   (final data collection date for primary outcome measure)

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)
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00690443
AEGR 733-006
No
Aegerion Pharmaceuticals, Inc.
Aegerion Pharmaceuticals, Inc.
Not Provided
Study Director: Steven Belknap, MD Medical Monitor at Radiant Research
Aegerion Pharmaceuticals, Inc.
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP