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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01604733
Other study ID # NIS-EG-CRE-2010/01
Secondary ID
Status Completed
Phase N/A
First received May 21, 2012
Last updated May 23, 2012
Start date October 2010
Est. completion date June 2011

Study information

Verified date May 2012
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Egypt: Institutional Review Board
Study type Observational

Clinical Trial Summary

Study objective is to evaluate the level of control of hypercholesterolemia in Egypt in patients taking lipid lowering agents for at least 3 months ( with no drug change or dose amendment for a minimum of 6 weeks).


Description:

Centralized Pan-Middle East Survey on the Undertreatment of Hypercholesterolemia


Recruitment information / eligibility

Status Completed
Enrollment 1000
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 18 years and above on current lipid lowering drug for at least 3 months with no dose change for a minimum of 6 weeks

- Subject must provide informed consent and comply with the survey procedures

Exclusion Criteria:

- Less than 18 years less than 3 months on antidyslipidemic agent Subjects who are unwilling or unable to provide informed consent

Study Design

Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Outcome

Type Measure Description Time frame Safety issue
Primary The proportion of patients on lipid-lowering treatment reaching the LDL-C goals according to the NCEP ATP III/ updated 2004 NCEP ATP III , overall and by country 24 weeks No
Secondary The proportion of patients on lipid-lowering treatment reaching the LDL-C goals according to the NCEP ATP III/ updated 2004 NCEP ATP III , in the following sub-populations: - primary/secondary prevention patients and with metabolic syndromes 24 weeks No
Secondary The proportion of patients on lipid-lowering treatment reaching the LDL-C goals according to the Third Joint European Task Force guideline, in the following sub-populations: - primary/secondary prevention patients and with metabolic syndromes 24 weeks No
Secondary Determinants (e.g. patient and physician characteristics , country-specific guidelines or recommendations) for undertreatment of hypercholesterolemia 24 weeks No
Secondary Physician characteristics associated with the allocation of treatment regimen. 24 weeks No
Secondary The proportion of patients on lipid-lowering treatment reaching the non HDL-C goals according to the NCEP ATP III/ updated 2004 NCEP ATP III , in the sub-population patients with fasting triglycerides<200 mg/d 24 weeks No
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