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Evaluation of Ezetimibe and Atorvastatin Coadministration Versus Atorvastatin or Rosuvastatin Monotherapy in Japanese Patients With Hypercholesterolemia (Study P06027)

01:45 EDT 20th June 2013 | BioPortfolio

Summary

The purpose of this study is to evaluate the efficacy and safety of atorvastatin 10 mg and ezetimibe 10 mg coadministration in Japanese patients with hypercholesterolemia whose Low-density lipoprotein (LDL)-cholesterol levels have not reached the lipid management target value with atorvastatin 10 mg alone, versus increasing the dose of atorvastatin to 20 mg or changing to rosuvastatin 2.5 mg.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Conditions

Primary Hypercholesterolemia

Intervention

Ezetimibe, Atorvastatin, Atorvastatin, Rosuvastatin

Location

Coordinating Location
Osaka
Japan

Status

Recruiting

Source

Schering-Plough

Results (where available)

View Results

Links

Medical and Biotech [MESH] Definitions

Hypercholesterolemia

A condition with abnormally high levels of CHOLESTEROL in the blood. It is defined as a cholesterol value exceeding the 95th percentile for the population.

Safflower Oil

An oily liquid extracted from the seeds of the safflower, Carthamus tinctorius. It is used as a dietary supplement in the management of HYPERCHOLESTEROLEMIA. It is used also in cooking, as a salad oil, and as a vehicle for medicines, paints, varnishes, etc. (Dorland, 28th ed & Random House Unabridged Dictionary, 2d ed)

Pectins

High molecular weight polysaccharides present in the cell walls of all plants. Pectins cement cell walls together. They are used as emulsifiers and stabilizers in the food industry. They have been tried for a variety of therapeutic uses including as antidiarrheals, where they are now generally considered ineffective, and in the treatment of hypercholesterolemia.

Primary Nursing

The primary responsibility of one nurse for the planning, evaluation, and care of a patient throughout the course of illness, convalescence, and recovery.

Primary Care Nursing

Techniques or methods of patient care used by nurses as primary careproviders.

Clinical Trials [ 483 Associated Clinical Trials listed on BioPortfolio]

MK0653C in High Cardiovascular Risk Patients With High Cholesterol (Switch Study)

This study will compare the lipid-altering efficacy and safety of switching to co-administration of ezetimibe and atorvastatin versus treatment with atorvastatin or rosuvastatin in high ca...

Adding Ezetimibe Tablet to Ongoing Treatment With Atorvastatin in Subjects With High Cholesterol and Multiple Coronary Heart Disease Risk Factors (Study P04060)(COMPLETED)

This study is being conducted to compare the efficacy, safety, and tolerability of ezetimibe 10 mg coadministered with atorvastatin 10 mg versus atorvastatin 10 mg in Indonesian population...

Ezetimibe Plus (+) Simvastatin Versus Atorvastatin Comparative Study

This is an efficacy and safety study of ezetimibe (+) simvastatin compared to atorvastatin (ezetimibe/simvastatin) at week 6 in primary hypercholesterolemia patients in Korea.

Ezetimibe and Atorvastatin vs. Atorvastatin in Patients Age 65 and Older at High Risk for Coronary Heart Disease (CHD)

A 12 week clinical trial in patients 65 years of age and older with hypercholesterolemia at high risk for coronary heart disease to study the effects of atorvastatin and ezetimibe given in...

Ezetimibe Plus Atorvastatin Versus Atorvastatin Alone in Subjects With Primary Hypercholesterolemia (Study P03406)(COMPLETED)

To compare the efficacy of ezetimibe 10 mg added daily to ongoing treatment with atorvastatin 10 mg daily versus ezetimibe placebo added daily to ongoing treatment with atorvastatin 10 mg...

PubMed Articles [ 5048 Associated PubMed Articles listed on BioPortfolio]

Safety and Efficacy of Ezetimibe/Simvastatin Combination Versus Atorvastatin Alone in Adults ≥65 Years of Age With Hypercholesterolemia and With or at Moderately High/High Risk for Coronary Heart Disease (the VYTELD Study).

Higher than 80% of coronary heart disease-related mortality occurs in patients ≥65 years of age. Guidelines recommend low-density lipoprotein (LDL) cholesterol targets for these at-risk patients; ho...

Comparing the Effectiveness of Rosuvastatin and Atorvastatin in Preventing Cardiovascular Outcomes: Estimates Using the Archimedes Model.

Abstract Objective: This study used simulation to compare the effectiveness of rosuvastatin 20 mg vs. atorvastatin 40 mg, and rosuvastatin 40 mg vs. atorvastatin 80 mg in preventing MACE in a range of...

Enhanced spectrophotometric determination of two antihyperlipidemic mixtures containing ezetimibe in pharmaceutical preparations.

Two spectrophotometric methods are presented for the simultaneous determination of ezetimibe/simvastatin and ezetimibe/atorvastatin binary mixtures in combined pharmaceutical dosage forms without prio...

Effect of Atorvastatin vs. Rosuvastatin on Cardiac Sympathetic Nerve Activity in Non-Diabetic Patients With Dilated Cardiomyopathy.

Background: Effects of statin therapy on cardiac sympathetic nerve activity in patients with chronic heart failure (CHF) have not previously been evaluated. Methods and Results: To compare the effects...

Impact of Restricted Reimbursement on the Use of Statins in Finland: A Register-Based Study.

OBJECTIVES:: New and expensive medicines are a driving force behind growth in medicine costs, and policies promoting use of less expensive products have been widely introduced. This study investigated...

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