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A Prospective, Open Label Comparison of Ezetimibe, Niacin, and Colestipol as Adjunct Therapy in Lipid Reduction

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ClinicalTrials.gov Identifier: NCT00203476
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : August 12, 2014
Last Update Posted : August 12, 2014
Sponsor:
Collaborator:
American Society of Health-System Pharmacists Research and Education Foundation
Information provided by (Responsible Party):
Raela Williford, PharmD, Tuscaloosa Research & Education Advancement Corporation

September 12, 2005
September 20, 2005
December 5, 2013
August 12, 2014
August 12, 2014
May 2005
January 2008   (Final data collection date for primary outcome measure)
LDL Goal Attainment [ Time Frame: 12 weeks ]
Each participant had his LDL goal calculated based on the NCEP ATPIII guidelines.
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 i
Complete list of historical versions of study NCT00203476 on ClinicalTrials.gov Archive Site
  • LFT Elevation [ Time Frame: 12 weeks ]
  • Incidents of Rhabdomyolysis [ Time Frame: 12 weeks ]
  • Change in HDL From Baseline to 12 Weeks. [ Time Frame: baseline and 12 weeks ]
. 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.
Not Provided
Not Provided
 
A Prospective, Open Label Comparison of Ezetimibe, Niacin, and Colestipol as Adjunct Therapy in Lipid Reduction
A Prospective, Open Label Comparison of Ezetimibe, Niacin, and Colestipol as Adjunct Therapy in Lipid Reduction
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.
: Patients with hyperlipidemia who sign consent and who are currently at maximum tolerated dose of a statin and are not meeting NCEP ATPIII treatment goals for LDL cholesterol are enrolled in 12-week open label, prospective trial. Patients are randomized into one of three groups to receive ezetimibe, niacin, or colestipol in addition to current statin therapy. Patients are titrated as tolerated to therapeutic doses of study medications (ezetimibe 10mg/day, niacin 1500mg/day, and colestipol 20gm/day). At baseline, informed consent; a laboratory admission profile (Chem20); weight; height; blood pressure; concomitant medications; cholesterol medication history; and grapefruit juice consumption data are gathered. At weeks 6 and 12, patients have their cholesterol panels and liver function tests assessed. Patients are also interviewed regarding side effects (including rhabdomyolysis), tolerance, changes in concomitant medications, and grapefruit juice consumption, along with weight and blood pressure measurements.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Hyperlipidemia
  • Hypercholesterolemia
  • Drug: Niacin
  • Drug: Colestipol
  • Drug: Ezetimibe
    Other Name: Zetia
  • Active Comparator: Statin with Niacin
    Niacin dose range of 500-1500mg (average 888mg)
    Intervention: Drug: Niacin
  • Active Comparator: Statin with Colestipol
    Colestipol dose range 5-15gm (average 9.5gm)
    Intervention: Drug: Colestipol
  • Active Comparator: Statin with Ezitimibe
    Ezitimibe 10mg (average 10mg)
    Intervention: Drug: Ezetimibe
Ansell BJ. Rationale for combination therapy with statin drugs in the treatment of dyslipidemia. Curr Atheroscler Rep. 2005 Feb;7(1):29-33. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
90
January 2008
January 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Veterans eligible for treatment at the Tuscaloosa VA Medical Center
  • 50 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

Exclusion Criteria:

  • 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
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00203476
TREAC Cholesterol Study
TREAC Cholesterol Study
No
Not Provided
Not Provided
Raela Williford, PharmD, Tuscaloosa Research & Education Advancement Corporation
Tuscaloosa Research & Education Advancement Corporation
American Society of Health-System Pharmacists Research and Education Foundation
Principal Investigator: Raela B Williford, PharmD Tuscaloosa VA Medical Center
Tuscaloosa Research & Education Advancement Corporation
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP