NCT00203476

Brief Summary

To compare LDL reduction compared to baseline in patients using maximum tolerated HMG CoA Reductase inhibitor (statin) therapy with adjunctive therapy with ezetimibe, colestipol, or niacin. The patient's cardiovascular risks are assessed to determine if National Cholesterol Education Program's Adult Treatment Panel III (NCEP ATP III) guidelines for low density lipoprotein (LDL) reduction were achieved between the three groups. Secondary measures examine the safety issues with liver function test (LFT) monitoring and rhabdomyolysis. High-density lipoproteins (HDL) elevations are monitored between the three groups to determine efficacy as a secondary outcome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2005

Typical duration for phase_4

Geographic Reach
1 country

1 active site

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, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
6.6 years until next milestone

Results Posted

Study results publicly available

August 12, 2014

Completed
Last Updated

August 12, 2014

Status Verified

August 1, 2014

Enrollment Period

2.7 years

First QC Date

September 12, 2005

Results QC Date

December 5, 2013

Last Update Submit

August 8, 2014

Conditions

HyperlipidemiaHypercholesterolemia

Keywords

ezetimibeniacincolestipolhyperlipidemiaadjunct therapyzetia

Outcome Measures

Primary Outcomes (1)

  • LDL Goal Attainment

    Each participant had his LDL goal calculated based on the NCEP ATPIII guidelines.

    12 weeks

Secondary Outcomes (3)

  • LFT Elevation

    12 weeks

  • Incidents of Rhabdomyolysis

    12 weeks

  • Change in HDL From Baseline to 12 Weeks.

    baseline and 12 weeks

Study Arms (3)

Statin with Niacin

ACTIVE COMPARATOR

Niacin dose range of 500-1500mg (average 888mg)

Drug: Niacin

Statin with Colestipol

ACTIVE COMPARATOR

Colestipol dose range 5-15gm (average 9.5gm)

Drug: Colestipol

Statin with Ezitimibe

ACTIVE COMPARATOR

Ezitimibe 10mg (average 10mg)

Drug: Ezetimibe

Interventions

NiacinDRUG
Statin with Niacin
ColestipolDRUG
Statin with Colestipol
EzetimibeDRUG
Also known as: Zetia
Statin with Ezitimibe

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Veterans eligible for treatment at the Tuscaloosa VA Medical Center
  • years of age
  • Male or female
  • Any race or ethnic group
  • Signed informed consent
  • Hyperlipidemia despite current maximum tolerated dose of an HMG CoA Reductase inhibitor (statin) for \> 6 weeks
  • Currently not meeting NCEP ATPIII treatment goals for LDL cholesterol

You may not qualify if:

  • Known hypersensitivity or intolerance to ezetimibe, niacin, or colestipol
  • Previous failed adequate trial of adjunctive ezetimibe, niacin, or colestipol
  • Consumes more than 8oz. grapefruit juice daily
  • Significant medical condition that would impact safety evaluations (i.e. significantly elevated LFT, hepatitis, severe dermatitis, uncontrolled diabetes, severe GI disease, fibromyalgia, renal failure, recent CVA or MI, pancreatitis, etc.)
  • Receiving medications that would be contraindicated to use in combination with ezetimibe, niacin, or colestipol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tuscaloosa Research & Education Advancement Corporation

Tuscaloosa, Alabama, 35404, United States

Location

Related Publications (1)

  • Ansell BJ. Rationale for combination therapy with statin drugs in the treatment of dyslipidemia. Curr Atheroscler Rep. 2005 Feb;7(1):29-33. doi: 10.1007/s11883-005-0072-7.

    PMID: 15683599BACKGROUND

MeSH Terms

Conditions

HyperlipidemiasHypercholesterolemia

Interventions

NiacinColestipolEzetimibe

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-RingPolyaminesAminesOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgricultureAzetidinesAzetines

Limitations and Caveats

Open label.

Results Point of Contact

Title
Raela Williford, PharmD
Organization
TuscaloosaREAC
Raela.Williford@va.gov
(205) 554-2000

Study Officials

  • Raela B Williford, PharmD

    Tuscaloosa Veterans Affairs Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Pharmacist/PI

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

May 1, 2005

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

August 12, 2014

Results First Posted

August 12, 2014

Record last verified: 2014-08

Locations

US(1)