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

Sponsor:	Aegerion Pharmaceuticals, Inc.
Information provided by:	Aegerion Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00690443

Purpose

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	Intervention	Phase
Hypercholesterolemia	Drug: Atorvastatin Drug: AEGR-733	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Atorvastatin Atorvastatin calcium BMS201038

U.S. FDA Resources

Further study details as provided by Aegerion Pharmaceuticals, Inc.:

Primary Outcome Measures:

Percent change in LDL-C after 8 weeks of therapy [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	May 2008
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00690443

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

No publications provided

Responsible Party:	William Sasiela, Chief Medical Officer, Aegerion Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00690443 History of Changes
Other Study ID Numbers:	AEGR 733-006
Study First Received:	May 20, 2008
Last Updated:	June 23, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Aegerion Pharmaceuticals, Inc.:

Hyperlipidemia

Additional relevant MeSH terms:

Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents

Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012