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

NCT00690443 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2018-02-23

Study results available
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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.

Conditions

Interventions

DRUG

Atorvastatin

atorvastatin 20 mg tablets, daily dosing, for 8 weeks.

DRUG

AEGR-733

2.5 mg AEGR-733 capsules, daily dosing, 4 weeks followed by 5 mg AEGR-733 capsules, daily dosing, 4 weeks

Sponsors & Collaborators

  • Aegerion Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Steven Belknap, MD · Medical Monitor at Radiant Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00690443 on ClinicalTrials.gov