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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Coronary Heart Disease; Hypercholesterolemia

Intervention: Ezetimibe (Drug); Statin (Drug)

Phase: N/A

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

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.

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

Percentage of Patients Receiving Each Variant of Modified Lipid-lowering Therapy: Statin Dose Titration, Administration of a New Statin, Administration of a Ezetimibe in Addition to a Current Statin.

Percentage of Patients Per Group Who Reach Goal for Total Cholesterol (TC) (< 4.5 mmol/L) According to All-Russian Scientific Cardiologists Society (ARSCS) Recommendations by End of Observation

Percentage of Patients Per Group Who Reached Goal for Low Density Lipoprotein (LDL-C) (< 2.6 mmol/L) According to ARSCS Recommendations by End of Observation

Percentage of Relative Change of Total Cholesterol (TC) Level Measured on Visit 2 Compared With the Baseline (Visit 1) in Each of the Three Therapy Groups

Percentage of Relative Change of LDL-C Level Measured on Visit 2 Compared With the Baseline (Visit 1) in Each of the Three Therapy Groups

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.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male and Female, from 18 to 75 years old;

- Established diagnosis of CHD;

- Previous (at least, within 1 month before inclusion in the present study) treatment

with statin;

- Levels of plasma TC and LDL-C above the recommended target values

(TC> 4. 5 mmol\L; LDL-C> 2. 5 mmol/L);

- The written informed consent signed prior to the start of participation in the study.

Exclusion Criteria:

- Contraindications for statin and ezetimibe (Ezetrol) administration in accordance

with local Russian Federation medical instructions.

- Patients refused to participate in the study and/or did not sign informed consent

form.

Locations and Contacts

Additional Information

Starting date: January 2008
Last updated: June 23, 2015

Page last updated: August 23, 2015

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