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

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 2


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:

MedlinePlus related topics: Cholesterol

Drug Information available for: Atorvastatin Atorvastatin calcium Lomitapide Atorvastatin calcium trihydrate

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: Baseline and 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, Apolopoproteins A1 and B), High Sensitivity C-reactive Protein and Change in Body Weight. [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: Yes ]


Enrollment:	44
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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


Responsible Party:	Aegerion Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00690443 History of Changes
Other Study ID Numbers:	AEGR 733-006
Study First Received:	May 20, 2008
Results First Received:	January 18, 2013
Last Updated:	April 4, 2013
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 Calcium Anticholesteremic Agents	Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 27, 2016