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The Safety & Efficacy of Combination BMS-201038 (AEGR-733) & Ezetimibe vs. Monotherapy in Moderate Hypercholesterolemia

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ClinicalTrials.gov Identifier: NCT00405067
Recruitment Status : Completed
First Posted : November 29, 2006
Results First Posted : March 4, 2014
Last Update Posted : March 4, 2014
Sponsor:
Information provided by (Responsible Party):
Aegerion Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE November 28, 2006
First Posted Date  ICMJE November 29, 2006
Results First Submitted Date  ICMJE January 18, 2013
Results First Posted Date  ICMJE March 4, 2014
Last Update Posted Date March 4, 2014
Study Start Date  ICMJE May 2006
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2014)
Percent Change in LDL-C at 12 Weeks Therapy Compared to Baseline Between Treatments [ Time Frame: Baseline and 12 weeks of treatment ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 28, 2006)
% LDL-C at 12 weeks therapy compared to baseline between treatments
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2014)
  • Percent of Change at 12 Weeks Therapy Compared to Baseline Between Treatments for the Following Parameters: Total Cholesterol (TC) [ Time Frame: Baseline and 12 weeks of treatment ]
  • Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at 12 Weeks as Compared to Baseline. [ Time Frame: Baseline and 12 weeks of treatment ]
  • Percent Change in Tryglycerides (TGs) at 12 Weeks Compared to Baseline [ Time Frame: Baseline and 12 weeks of treatment ]
  • Percent Change in HDL-C at 12 Weeks Compared to Baseline [ Time Frame: Baseline and 12 weeks of treatment ]
  • Percent Change in Lipoprotein(a)[Lp(a)]at 12 Weeks as Compared to Baseline [ Time Frame: Baseline and 12 weeks of treatment ]
  • Percent Change in Apolipoprotein A1 (Apo A1) at 12 Weeks as Compared to Baseline [ Time Frame: baseline and 12 weeks of treatment ]
  • Percent Change in Apolipoprotein B (Apo B) at 12 Weeks as Compared to Baseline [ Time Frame: Baseline and 12 weeks of treatment ]
  • Percent Change in High-sensitivity C-reactive Protein (Hs-CRP) at 12 Weeks as Compared to Baseline [ Time Frame: Baseline and 12 weeks of treatment ]
  • Percent Change in Body Weight at 12 Weeks as Compared to Baseline [ Time Frame: Baseline and 12 weeks of treatment ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2006)
  • % changes at 12 weeks therapy compared to baseline between treatments for the following parameters:
  • other baseline serum lipoproteins (TC, non-HDL, VLDL, TG, HDL-C, Lp (a), apolipoproteins AI and B)
  • high sensitivity C-reactive protein
  • body weight
  • markers of safety and overall safety and tolerability.
  • Additional objectives are to characterize the safety and tolerability of BMS-201038 (AEGR-733) alone and in combination with ezetimibe.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Safety & Efficacy of Combination BMS-201038 (AEGR-733) & Ezetimibe vs. Monotherapy in Moderate Hypercholesterolemia
Official Title  ICMJE A Randomized, Double-Blind, Active Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of the Combination BMS-201038 (AEGR-733) and Ezetimibe vs. Monotherapy in Subjects With Moderate Hypercholesterolemia
Brief Summary The main objectives of this study are to evaluate the efficacy and safety of combination therapy BMS-201038 (AEGR-733) plus ezetimibe vs. each agent given alone on LDL cholesterol and other lipoproteins over 12 weeks of therapy.
Detailed Description

Subjects will participate in this study for approximately 14-17 weeks. This study has 2 periods: 1) a 1-2-week screening period with 2 visits where baseline cholesterol and other characteristics will be evaluated to determine study eligibility. This period also includes a 4-week washout for patients on prior lipid-lowering therapies; and 2) a 12-week treatment period with interim visits at weeks 4 and 8.

85 subjects were randomized into one of 3 treatment arms with equal probability. In treatment arm 1, subjects will receive BMS-201038 (AEGR-733) 5 mg plus ezetimibe placebo. In treatment arm 2, subjects will receive BMS-201038 (AEGR-733) placebo plus 10 mg of ezetimibe. In treatment arm 3, subjects will receive BMS-201038 (AEGR-733) 5 mg plus ezetimibe 10 mg. After 4 weeks of treatment, subjects in arms 1 and 3 will be force-titrated to BMS-201038 (AEGR-733) 7.5 mg. After another 4 weeks of treatment, subjects in arms 1 and 3 will then be force-titrated to BMS-201038 (AEGR-733) 10 mg for 4 more additional weeks of treatment. Subjects in arm 2 will continue to receive BMS-201038 (AEGR-733) matching placebo for the entire 12 weeks of treatment. Subjects randomized to ezetimibe 10 mg in arms 2 and 3 and ezetimibe placebo in arm 1 will remain on these doses for the entire 12-week treatment period.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Hypercholesterolemia
Intervention  ICMJE
  • Drug: BMS-201038 (AEGR-733)
  • Drug: Ezetimibe
Study Arms  ICMJE Not Provided
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: November 28, 2006)
60
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2007
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Men and women between the ages of 18 and 70 years .
  2. For subjects with 0 to 1 risk factor (cigarette smoking, hypertension (BP > 140/90 or on antihypertensive medication), low HDL (<40mg/dl), family history of premature CHD (CHD in male first degree relative <55 years; CHD in female first degree relative <65 years), age (men> 45 years; women > 55 years): Baseline mean LDL-C must be >160 and <250 mg/dl as determined by the arithmetic mean of measures taken at visit 1 and 2. Fasting mean TGs should be <400 mg/dl.
  3. For subjects with 2 or more risk factors (cigarette smoking, hypertension (BP > 140/90 or on antihypertensive medication), low HDL (<40mg/dl), family history of premature CHD (CHD in male first degree relative <55 years; CHD in female first degree relative <65 years), age (men> 45 years; women > 55 years) or prior stable CHD: Baseline mean LDL-C must be >130 and <250 mg/dl as determined by the arithmetic mean of measures taken at visit 1 and 2. Fasting mean TGs should be <400 mg/dl.
  4. Able to understand and willing to comply with all study requirements, particularly the study drug regimen.
  5. Able to understand and willing to sign the Informed Consent Form.

Exclusion Criteria:

  1. Women who are pregnant or lactating or who are planning to become pregnant or women of child bearing potential who have not successfully been using acceptable contraceptive methods over the previous 3 months (e.g. intrauterine device and barrier method plus spermicide).
  2. Uncontrolled hypertension defined as: systolic blood pressure > 180 mmHg, diastolic blood pressure > 95 mmHg
  3. History of chronic renal insufficiency (serum creatinine >2.5 mg/dL)
  4. History of liver disease or transaminases above 1.5 X ULN at screening
  5. Any major surgical procedure occurring less than 3 months prior to the screening visit
  6. Cardiac insufficiency defined by the NYHA classification as functional Class II-Class IV
  7. History of a malignancy (other than basal cell or squamous cell carcinoma of the skin that has been removed) within the previous 5 years
  8. Participation in an investigational drug study within 6 weeks prior to the screening visit.
  9. Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
  10. Regular alcohol use > 1 drink per day
  11. Regular consumers of grapefruit juice, or currently taking medications known to be metabolized by CYP 3A4 (cyclosporine, itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, and nefazodone)
  12. Other lipid-lowering medications (washouts will be permitted)
  13. Acute CVD (CVD event within the previous 6 months)
  14. Diabetes Mellitus
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT00405067
Other Study ID Numbers  ICMJE AEGR-733-001
Has Data Monitoring Committee Not Provided
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
Principal Investigator: Michael Davidson, MD Radiant Research
Principal Investigator: Jackson Downey, MD Jacksonville Center For Clinical Research
Principal Investigator: Paul Grena, MD Cardiology Consultants of Philadelphia
Principal Investigator: Barry Lubin, MD Hampton Roads Center for Clinical Research
Principal Investigator: James McKenney, Pharm D National Clinical Research
Principal Investigator: Eli Roth, MD Sterling Research Group, LTD
PRS Account Aegerion Pharmaceuticals, Inc.
Verification Date January 2014

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