Comparative Efficacy Evaluation of Lipids When Treated With Niaspan & Statin or Other Lipid-Modifying Therapies-COMPELL

NCT00079638 | Completed Phase 4

• 2 other identifiers: 001-09-03-CRCOMPELL
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the effectiveness of first-line treatment using Niaspan (an extended release version of niacin) and statins versus other drugs that lower lipid levels, in subjects with elevated fat levels in their blood (dyslipidemia). Statins are a class of medication that is often prescribed to patients who need to lower their cholesterol levels.

Conditions

Dyslipidemia; Coronary Heart Disease; Atherosclerosis; Stroke; Diabetes

Keywords

Niaspan; Niacin; Statin; Cholesterol; Triglycerides; Lipid-Modifying Therapies; Dyslipidemia; Coronary Heart Disease; Atherosclerosis; Stroke; VA-HIT; Niacin Statin Combination Threrapy; High Density Lipoprotein; Low Density Lipoprotein; Hypertension; Diabetes; Adult Treatment Panel III

Outcome Measures

Primary Outcomes (1)

• Mean percent change in LDL-C from Baseline to Week 12

Interventions

Niacin DRUG

Atorvastatin DRUG

Simvastatin DRUG

Ezetimibe DRUG

Rosuvastatin DRUG

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All of the following criteria must be answered "Yes":
• 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;
• Patient is willing to withdraw from any current anti-dyslipidemic medications or other prohibited medication for approximately 6 weeks prior to randomization (4 weeks prior to qualification visits) and for the duration of the study;
• If the patient is female, the patient must not be pregnant or breast-feeding and not planning to become pregnant or to breast-feed for the duration of the study. Women of childbearing potential must commit to using a medically acceptable method of birth control such as oral contraception, intrauterine device (IUD), or a double-barrier method of contraception. Women using oral contraception must have done so for at least 3 months prior to randomization, and continue to do so for the duration of the study. To be considered not of childbearing potential, women must be post-menopausal for at least 2 years or surgically sterile.

You may not qualify if:

• All the following criteria must be answered "No":
• 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;
• Patient has taken a prohibited medication within 4 weeks of obtaining qualification labs for the study (See section 8.0 - Concomitant Medications);
• Patient has a history of any of the following:
• active gallbladder disease within the preceding 12 months (cholecystectomy is allowed);
• pancreatitis;
• liver disease (e.g., hepatitis B and/or C);
• persistent uncontrolled or untreated severe hypertension;
• Type I or Type II diabetes;
• persistent uncontrolled or untreated hypothyroidism;
• arterial bleeding;
• unstable angina;

Sponsors & Collaborators

• Kos Pharmaceuticals: lead

MeSH Terms

Conditions

Dyslipidemias; Coronary Disease; Atherosclerosis; Stroke; Diabetes Mellitus; Hypertension

Interventions

Niacin; Atorvastatin; Simvastatin; Ezetimibe; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Glucose Metabolism Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Azetidines; Azetines; Sulfonamides; Amides; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Sulfones; Sulfur Compounds; Pyrimidines

Study Officials

• COMPELL TEAM

  Contact COMPELL Team Member (800) 722-4567

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 10, 2004
• First Posted: March 12, 2004
• Study Start: April 1, 2004
• Study Completion: May 1, 2005
• Last Updated: November 1, 2006

Record last verified: 2006-10