NCT00690443

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2008

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 4, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

February 25, 2013

Completed
Last Updated

February 23, 2018

Status Verified

February 1, 2018

Enrollment Period

4 months

First QC Date

May 20, 2008

Results QC Date

January 18, 2013

Last Update Submit

February 21, 2018

Conditions

Hypercholesterolemia

Keywords

Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

  • Percent Change in LDL-C After 8 Weeks of Therapy

    Baseline and 8 weeks of treatment

Secondary Outcomes (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.

    Baseline and 4 weeks

Study Arms (2)

2

ACTIVE COMPARATOR

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

1

ACTIVE COMPARATOR

Following 35-day washout + diet run-in, subjects receive atorvastatin 20 mg for 8 wks.

Drug: Atorvastatin

Interventions

AtorvastatinDRUG

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

Also known as: Lipitor
1
AEGR-733DRUG

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

2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • M/F 18-70
  • risk factor, mean LDL-C -/\> 160 and -/\< 250 mg/dL (Visit 2 \& 3)
  • + 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Linda Murray, DO - Radiant Research

Pinellas Park, Florida, 33781, United States

Location

Sheila Rodstein, MD

Edina, Minnesota, 55435, United States

Location

Dennis McCluskey, MD - Radiant Research

Mogadore, Ohio, 44260, United States

Location

Michele Reynolds, MD

Dallas, Texas, 75231, United States

Location

William Jennings, MD - Radiant Research

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

HypercholesterolemiaHyperlipidemias

Interventions

AtorvastatinBMS201038

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Results Point of Contact

Title
Chief Medical Officer
Organization
Aegerion Pharmaceuticals
617-500-7867

Study Officials

  • Steven Belknap, MD

    Medical Monitor at Radiant Research

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2008

First Posted

June 4, 2008

Study Start

May 1, 2008

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

February 23, 2018

Results First Posted

February 25, 2013

Record last verified: 2018-02

Locations

US(5)