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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.

Tracking Information
First Submitted Date  ICMJE May 20, 2008
First Posted Date  ICMJE June 4, 2008
Results First Submitted Date  ICMJE January 18, 2013
Results First Posted Date  ICMJE February 25, 2013
Last Update Posted Date February 23, 2018
Study Start Date  ICMJE May 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2013)
Percent Change in LDL-C After 8 Weeks of Therapy [ Time Frame: Baseline and 8 weeks of treatment ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 3, 2008)
Percent Change in LDL-C After 8 Weeks of Therapy [ Time Frame: 8 weeks of treatment ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2013)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2008)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluate Safety and Efficacy of AEGR-733 and Atorvastatin vs Atorvastatin Monotherapy in Hypercholesterolemia
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hypercholesterolemia
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 18, 2013)
44
Original Estimated Enrollment  ICMJE
 (submitted: June 3, 2008)
50
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00690443
Other Study ID Numbers  ICMJE AEGR-733-006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Aegerion Pharmaceuticals, Inc.
Study Sponsor  ICMJE Aegerion Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Steven Belknap, MD Medical Monitor at Radiant Research
PRS Account Aegerion Pharmaceuticals, Inc.
Verification Date February 2018

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