Evaluation of the LDL-C Lowering Effects of Ezetimibe Achieved in Co-administration Therapy With Statins in an Indonesian Population (Study P04276)(COMPLETED)

Hypercholesterolemia Clinical Trial

Official title:

Observational Study Evaluating the LDL-C Lowering Effects of Ezetimibe With a Statin as Prescribed in Daily Routine Practice in an Indonesian Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00705081
• Other study ID #: P04276
• Status: Completed
• Start date: January 2006
• Est. completion date: December 2007

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate the safety and tolerability of the low-density lipoprotein-cholesterol (LDL-C) lowering in an Indonesian population treated with ezetimibe co-administered with a statin in routine daily practice. In addition, the study will investigate whether and to what extent the target levels set by the participating doctors are achieved by the co-administration therapy.

Description:

Sampling method: invitation to the physician's patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 453
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All subjects that were to receive ezetimibe 10 mg as prescribed in daily practice

Exclusion Criteria:

• N/A

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• ezetimibe
10 mg once daily
• statin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Reporting Adverse Events	Safety and tolerability of LDL lowering with co-administration therapy as measured by the number of participants reporting adverse events (AE). (AE defined as any untoward medical occurrence or unfavorable and unintended sign in a subject administered the pharmaceutical product whether or not considered related to the use of that product.)	4-6 weeks after the first visit
Primary	Intensity of Adverse Events Reported	Intensity of adverse events reported after co-administration therapy	4-6 weeks after the first visit
Primary	Participants Achieving Low-density Lipoprotein-cholesterol (LDL-C) Target Levels With Co-administration Therapy	Achievement of LDL-C target levels as determined by physician	4-6 weeks after the first visit