NCT00730132

Observational Study of Approaches to Lipid-Lowering Therapy in Russian Patients With Coronary Heart Disease <<Treat to Goal>> (Study P05464)

Observational Study of Approaches to Lipid-lowering Therapy in Russian Patients With Coronary Heart Disease (<<Treat to Goal>>)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 712 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is being performed to evaluate what variants of lipid-lowering therapy are used in Russian clinical practice in coronary heart disease (CHD) patients with hypercholesterolemia in whom the initial statin therapy did not achieve low density lipoprotein-cholesterol (LDL-C) goals. Additionally, the efficacy and safety of all variants of modified lipid-lowering therapy are to be evaluated.

Detailed description

Given the observational nature of this study and that the assessment of a specific hypothesis is not foreseen, statistical assumption is not planned and the sample size calculation was not performed. Taking into consideration the available data on the established safety profile of the therapy with statins and combination of ezetimibe with statins it has been suggested that a sample size of 750 patients will be sufficient to identify adverse events profile. The treatment effects will be characterized by descriptive and frequency parameters.

Conditions

• Coronary Heart Disease
• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	Ezetimibe	Dosage determined by the investigator based on standard and applicable routine clinical practice for CHD and hypercholesterolemia patients
DRUG	Statin	Statin titration for the Statin Dose Titration group, and new statin treatment and dosage for the New Statin group, determined by the investigator based on standard and applicable routine clinical practice for CHD and hypercholesterolemia patients

Timeline

• Start date: 2008-01-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2008-08-08
• Last updated: 2022-02-09
• Results posted: 2010-10-11