Evaluate Safety and Efficacy of AEGR-733 and Atorvastatin vs Atorvastatin Monotherapy in Hypercholesterolemia

• 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: Aegerion Pharmaceuticals, Inc.
• Information provided by (Responsible Party): Aegerion Pharmaceuticals, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hypercholesterolemia	Drug: Atorvastatin; Drug: AEGR-733	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: May 2008
• Actual Primary Completion Date: September 2008
• Actual Study Completion Date: September 2008

Arms and Interventions

Arm	Intervention/treatment
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	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: 1; Following 35-day washout + diet run-in, subjects receive atorvastatin 20 mg for 8 wks.	Drug: Atorvastatin; atorvastatin 20 mg tablets, daily dosing, for 8 weeks.; Other Name: Lipitor

Outcome Measures

Primary Outcome Measures :

1. Percent Change in LDL-C After 8 Weeks of Therapy [ Time Frame: Baseline and 8 weeks of treatment ]

Secondary Outcome Measures :

1. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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)

Contacts and Locations

Locations

United States, Florida

Linda Murray, DO - Radiant Research

Pinellas Park, Florida, United States, 33781

United States, Minnesota

Sheila Rodstein, MD

Edina, Minnesota, United States, 55435

United States, Ohio

Dennis McCluskey, MD - Radiant Research

Mogadore, Ohio, United States, 44260

United States, Texas

Michele Reynolds, MD

Dallas, Texas, United States, 75231

William Jennings, MD - Radiant Research

San Antonio, Texas, United States, 78229

Sponsors and Collaborators

Aegerion Pharmaceuticals, Inc.

Investigators

• Study Director: Steven Belknap, MD; Medical Monitor at Radiant Research

More Information

• Responsible Party: Aegerion Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT00690443
• Other Study ID Numbers: AEGR-733-006
• First Posted: June 4, 2008
• Results First Posted: February 25, 2013
• Last Update Posted: February 23, 2018
• Last Verified: February 2018

Keywords provided by Aegerion Pharmaceuticals, Inc.:

Hyperlipidemia

Additional relevant MeSH terms:

Hypercholesterolemia; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Atorvastatin; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Enzyme Inhibitors