Completed

Niaspan and Statin vs. Other Lipid-Modifying Therapies for Dyslipidemia

What is being tested

Data Collection

Who is being recruted

Arterial Occlusive Diseases+18

+ Arteriosclerosis

+ Brain Diseases

Over 21 Years

+15 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 4

Interventional

Study Start: April 2004

See protocol details

Summary

Principal SponsorKos Pharmaceuticals

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2004

Actual date on which the first participant was enrolled.

This study is about comparing the effectiveness of different treatments for dyslipidemia, a condition where there are high levels of cholesterol or fats in the blood. The treatments being compared include a combination of Niaspan and atorvastatin, a combination of simvastatin and ezetimibe, rosuvastatin alone, and a combination of Niaspan and rosuvastatin. The goal is to see which of these treatments works best for managing dyslipidemia. This study is important for adults aged 21 years and older who are eligible for treatment based on the National Cholesterol Education Program Adult Treatment Panel III recommendations and have triglycerides levels less than or equal to 300 mg/dL. The results of this study could help improve care for people with dyslipidemia by identifying the most effective treatment options. During this 12-week study, participants are randomly assigned to one of four treatment groups. In the first group, participants receive a combination of Niaspan and atorvastatin, with the doses adjusted to 2000 mg and 40 mg, respectively. The second group receives a combination of simvastatin, adjusted to 40 mg, and ezetimibe, maintained at 10 mg. The third group receives rosuvastatin alone, with the dose adjusted to 40 mg. The fourth group receives a combination of Niaspan and rosuvastatin, with the doses adjusted to 1000 mg and 20 mg, respectively. The study measures the change in LDL-C (low-density lipoprotein cholesterol, also known as 'bad' cholesterol) from the start to the end of the study to evaluate the effectiveness of each treatment.

Official TitleComparative Efficacy Evaluation of Lipid Levels When Treated With Niaspan and Statin or Other Lipid-Modifying Therapies

NCT00079638

Principal SponsorKos Pharmaceuticals

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

300 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 21 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arterial Occlusive DiseasesArteriosclerosisBrain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesCerebrovascular DisordersCoronary DiseaseDiabetes MellitusEndocrine System DiseasesHeart DiseasesHypertensionMetabolic DiseasesNervous System DiseasesNutritional and Metabolic DiseasesVascular DiseasesMyocardial IschemiaStrokeGlucose Metabolism DisordersDyslipidemiasAtherosclerosisLipid Metabolism Disorders

Criteria

6 inclusion criteria required to participate

Patient is 21 years of age or older and willing to participate for the duration of the study;

Patient has read, signed, and agreed to the items listed in the informed consent form and HIPAA authorization form prior to the initiation of any study procedures and/or discontinuing any medications;

Patient is eligible for treatment following the drug washout period based upon the NCEP ATP III entry criteria and the LDL-C variability ≤ 15%;

Patient has mean triglyceride level (TG) ≤ 300 mg/dL;

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9 exclusion criteria prevent from participating

Patient has an allergy, hypersensitivity, or intolerance to niacin, simvastatin, atorvastatin, ezetimibe, rosuvastatin or their derivatives;

Patient drinks more than 14 alcoholic drinks per week or has a previous history (within 12 months of screening) of substance abuse or dependency;

Patient has untreated or unsuccessfully treated psychiatric disease;

Patient has used an investigational study medication or participated in an investigational study within 30 days of obtaining qualification labs;

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

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CompletedNo study centers