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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2008-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparative Study of the Effect of Ezetimibe Versus Extended-Release Niacin on Atherosclerosis

NCT00397657

Atherosclerosis

TERMINATED PHASE4

Study of an Approved Drug With a Statin (a Medication That Lowers Cholesterol Levels) as Compared to Statin Therapy Alone in Patients With High Cholesterol (0653-040)

NCT00092586

Hypercholesterolemia

COMPLETED PHASE3

Comparison of Ezetimibe Added to Ongoing Statin Therapy Versus Doubling the Dose of Statin in the Treatment of Hypercholesterolemia (P04355)

NCT00652327

Hypercholesterolemia

COMPLETED PHASE4

Randomized Parallel Group Trial Of The Efficacy And Safety Of Ezetimibe With A Statin Versus Statin Dose Doubling In Patients With Persistent Primary Hypercholesterolemia (0653-152)(COMPLETED)

NCT00652847

Hypercholesterolemia

COMPLETED PHASE4

Comparison of High-Dose Rosuvastatin Versus Low Statin Dose Plus Fenofibrate Versus Low Statin Dose Plus Niacin in the Treatment of Mixed Hyperlipidemia

NCT01010516

Dyslipidemia

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

: 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hyperlipidemia Hypercholesterolemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Statin with Niacin

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

Group Type ACTIVE_COMPARATOR

Niacin

Intervention Type DRUG

Statin with Colestipol

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

Group Type ACTIVE_COMPARATOR

Colestipol

Intervention Type DRUG

Statin with Ezitimibe

Ezitimibe 10mg (average 10mg)

Group Type ACTIVE_COMPARATOR

Ezetimibe

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Niacin

Intervention Type DRUG

Colestipol

Intervention Type DRUG

Ezetimibe

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Zetia

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No