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

NCT00405067 | Completed Phase 2 Results

• 1 other identifier: AEGR-733-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypercholesterolemia

Keywords

Cholesterol

Outcome Measures

Primary Outcomes (1)

• Percent Change in LDL-C at 12 Weeks Therapy Compared to Baseline Between Treatments

  Baseline and 12 weeks of treatment

Secondary Outcomes (9)

• Percent of Change at 12 Weeks Therapy Compared to Baseline Between Treatments for the Following Parameters: Total Cholesterol (TC)

  Baseline and 12 weeks of treatment

• Percent Change in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at 12 Weeks as Compared to Baseline.

  Baseline and 12 weeks of treatment

• Percent Change in Tryglycerides (TGs) at 12 Weeks Compared to Baseline

  Baseline and 12 weeks of treatment

• Percent Change in HDL-C at 12 Weeks Compared to Baseline

  Baseline and 12 weeks of treatment

• Percent Change in Lipoprotein(a)[Lp(a)]at 12 Weeks as Compared to Baseline

  Baseline and 12 weeks of treatment

Interventions

BMS-201038 (AEGR-733) DRUG

Ezetimibe DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women between the ages of 18 and 70 years .
• 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.
• 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.
• Able to understand and willing to comply with all study requirements, particularly the study drug regimen.
• Able to understand and willing to sign the Informed Consent Form.

You may not qualify if:

• 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).
• Uncontrolled hypertension defined as: systolic blood pressure \> 180 mmHg, diastolic blood pressure \> 95 mmHg
• History of chronic renal insufficiency (serum creatinine \>2.5 mg/dL)
• History of liver disease or transaminases above 1.5 X ULN at screening
• Any major surgical procedure occurring less than 3 months prior to the screening visit
• Cardiac insufficiency defined by the NYHA classification as functional Class II-Class IV
• History of a malignancy (other than basal cell or squamous cell carcinoma of the skin that has been removed) within the previous 5 years
• Participation in an investigational drug study within 6 weeks prior to the screening visit.
• 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.
• Regular alcohol use \> 1 drink per day
• 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)
• Other lipid-lowering medications (washouts will be permitted)
• Acute CVD (CVD event within the previous 6 months)
• Diabetes Mellitus

Sponsors & Collaborators

• Aegerion Pharmaceuticals, Inc.: lead

Study Sites (1)

Pharmanet, Inc

Princeton, New Jersey, 08540-6242, United States

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

BMS201038; Ezetimibe

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Aegerion Pharmaceuticals

617-500-7867

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2006
• First Posted: November 29, 2006
• Study Start: May 1, 2006
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: March 4, 2014
• Results First Posted: March 4, 2014

Record last verified: 2014-01

Locations

US (1)