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Clinical Trials/NCT00651963
NCT00651963CompletedPhase 4

Open Label Study Evaluating The Use Of Combination Therapy Of Ezetimibe And Statins In Patients With Dyslipidemia In Colombia

Organon and Co0 sites80 target enrollmentStarted: September 1, 2004Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
80
Primary Endpoint
Lipid profile
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Gather additional efficacy and safety (pharmacovigilance) information in the usual daily care in patients with Dyslipidemia on ezetimibe under real conditions in Colombia associated with statins.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •> 18 years old
  • •Lipid Metabolic Disorder as Per ATP III who have not reached the goals and who are on statins for at least 4 weeks Or those who require LDL reductions Over 50% to reach the ATP III goals or who need statins in accordance their risk score

Exclusion Criteria

  • •Pregnancy, Breast Feeding
  • •Moderate/Sever Liver Disease: Child Score > Or = To 7
  • •Fibrates Terminal Disease
  • •Contraindications To Receive ezetimibe
  • •Contraindications To Receive Statins
  • •Mental Disability
  • •Hypersensitivity To ezetimibe
  • •On another Clinical Research Trial

Outcomes

Primary Outcomes

Lipid profile

Time Frame: Over 8 Weeks

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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