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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: BMS-201038 (AEGR-733) Drug: Ezetimibe Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2006
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Percent Change in LDL-C at 12 Weeks Therapy Compared to Baseline Between Treatments [ Time Frame: Baseline and 12 weeks of treatment ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Percent Change in Tryglycerides (TGs) at 12 Weeks Compared to Baseline [ Time Frame: Baseline and 12 weeks of treatment ]
  4. Percent Change in HDL-C at 12 Weeks Compared to Baseline [ Time Frame: Baseline and 12 weeks of treatment ]
  5. Percent Change in Lipoprotein(a)[Lp(a)]at 12 Weeks as Compared to Baseline [ Time Frame: Baseline and 12 weeks of treatment ]
  6. Percent Change in Apolipoprotein A1 (Apo A1) at 12 Weeks as Compared to Baseline [ Time Frame: baseline and 12 weeks of treatment ]
  7. Percent Change in Apolipoprotein B (Apo B) at 12 Weeks as Compared to Baseline [ Time Frame: Baseline and 12 weeks of treatment ]
  8. 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 ]
  9. Percent Change in Body Weight at 12 Weeks as Compared to Baseline [ Time Frame: Baseline and 12 weeks of treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT00405067


Locations
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United States, New Jersey
Pharmanet, Inc
Princeton, New Jersey, United States, 08540-6242
Sponsors and Collaborators
Aegerion Pharmaceuticals, Inc.
Investigators
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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

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Responsible Party: Aegerion Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00405067    
Other Study ID Numbers: AEGR-733-001
First Posted: November 29, 2006    Key Record Dates
Results First Posted: March 4, 2014
Last Update Posted: March 4, 2014
Last Verified: January 2014
Keywords provided by Aegerion Pharmaceuticals, Inc.:
Cholesterol
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents