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Guidelines Based Undertaking for Improvement in Dyslipidemia Related Events (GUIDE )

NCT00408057 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2500

Last updated 2008-05-14

No results posted yet for this study

Summary

This is a multi-center, open label observational study conducted over 26 weeks.

Approximately 2,500 high-risk patients with an elevated LDL-C level (\> 2.5 mmol/L) will be enrolled. Patients meeting all inclusion criteria and having none of the exclusion criteria at Visit 1 (Screening) will be included in the study. Eligible patients that agree to participate and sign an informed consent will be treated with either statin therapy (increased or started or switched) or combination of statin and ezetimibe 10 mg (added/started) as per Study Schematic (Table 1) in order to achieve the recommended target of LDL\<2.5 mmol/L and providing that this treatment is in the best interest of the patient.

After enrollment there are a total of three scheduled clinic visits. All patients will have vital signs measured as well as a brief physical examination performed at Visit 1 (Screening).

At Visit 2 (6 weeks) patients with LDL-C \> 2.5mmol/L will be treated with either statin therapy increase or combination of statin and ezetimibe 10 mg (added/started) as per Study Schematic (Table 1) in order to achieve the recommended target of LDL\<2.5 mmol/L and providing that this treatment is in the best interest of the patient.

At Visit 3 (12 -18 weeks) patients with LDL \> 2.5 mmol/L will be treated with combination of statin and ezetimibe 10 mg as per Study Schematic (Table 1) in order to achieve the recommended target of LDL\<2.5 mmol/L and providing that this treatment is in the best interest of the patient.

At final Visit 4 (24-26 weeks) safety and efficacy of treatment will be reviewed. Following Visit 4 physicians will continue to treat these patients according to their clinical judgment.

Conditions

Interventions

OTHER

no intervention

no intervenion

Sponsors & Collaborators

  • Merck Frosst Canada Ltd.

    collaborator INDUSTRY

  • Schering-Plough

    collaborator INDUSTRY

  • Canadian Heart Research Centre

    lead OTHER

Principal Investigators

  • Lawrence Leiter, MD · University of Toronto

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2007-11-30
Completion
2007-11-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00408057 on ClinicalTrials.gov