Open Label Study Evaluating The Use Of Combination Therapy Of Ezetimibe And Statins In Patients With Dyslipidemia In Colombia (0653-141)(COMPLETED)

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00651963

Enrollment

Registered

2008-04-03

Start date

2004-09-30

Completion date

2005-03-31

Last updated

2024-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lipid Metabolism Disorder

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.

Interventions

DRUGezetimibe

Ezetimibe 10 mg daily was added during 4 weeks. The patients continued taking their usual Statin without titrating the dose.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Lipid profile	Over 8 Weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026