An Observational Study Evaluating Cholesterol Levels in Patients on Cholesterol Lowering Drugs in Jordan and Lebanon

NCT01614561 | Completed

• 1 other identifier: NIS-LT-CRE-2010/01
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

This was a multicenter survey of patients who were on lipid -lowering pharmacological treatment in 2 Levant countries namely Jordan and Lebanon. The purpose is to study the effects of cholesterol lowering drugs on the blood cholesterol levels of patients in Jordan and Lebanon. Data collected from each patient took place at a single visit. Each participating doctor filled the investigator questionnaire on his/her experience and perception of the management of the hypercholesterolemia of his/her patients. Each doctor was asked to indicate his/her general attitude on the diagnosis of hypercholesterolemia, the existing guidelines and goals and the various treatment options for high cholesterol in blood. Before being assessed by the investigator, patients recorded, on the patient questionnaire, their awareness of high blood cholesterol , their current lipid-lowering treatment schedule, their understanding of their condition and compliance in taking the medications on time. The investigators completed a Patient Record Form (PRF) with the patient's basic information, cardiovascular risk factors and the cardiovascular medical history, current lipid lowering drug treatment and the reason for the current therapy. A blood sample under fasting condition was drawn from each subject. A central laboratory in Jordan received all samples. Every sample was analyzed for its cholesterol blood level, fasting sugar level and hemoglobin A1C levels.

Conditions

High Blood Cholesterol

Keywords

Hypercholesterolemia; Lipid lowering drugs; Cholesterol level in blood; Target cholesterol levels guidelines for the management of high blood cholesterol

Outcome Measures

Primary Outcomes (1)

• Number and percentage of subjects achieving the LDL-C goals, according to the NCEP ATP III / updated 2004 NCEP ATP III guidelines, in Jordan and Lebanon

  5 months- One visit only, no follow up visits

Secondary Outcomes (5)

• Number and percentage of subjects achieving LDL-C goals according to the NCEP ATP III / 2004 updated NCEP ATP III guidelines, for several subject subsets

  5 months- One visit only, no follow up visits

• Number and percentage of subjects achieving the LDL-C goals, according to the Third Joint European Task Force guidelines, overall and for several subject subsets

  5 months- One visit only, no follow up visits

• Number and percentage of subjects achieving the non HDL-C goals according to the NCEP ATP III / updated 2004 NCEP ATP III / national guidelines (<130 mg/dL), in the following sub-population: patients with fasting triglycerides >200 mg/dL.

  5 months- One visit only, no follow up visits

• Achievement of LDL-C goals, according to the Third Joint European Task Force TJETF / NCEP ATP III / 2004 updated NCEP ATP III guidelines, and patient and physician variables. Assessed using Multivariate logistic regression mode

  5 months- One visit only, no follow up visits

• Physician characteristics associated with the allocation of treatment regimen.

  5 months- One visit only, no follow up visits

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients attending out patient clinics in Jordan and Lebanon

You may qualify if:

• Adult patients with high cholesterol blood levels willing to participate in the study
• Patients must be on cholesterol lowering medications for three months with no dose change for six weeks

You may not qualify if:

• Patients not on cholesterol lowering medications or on medications for less than three months
• Any medication dose change in six weeks prior to their visit

Sponsors & Collaborators

• AstraZeneca: lead

Biospecimen

Retention: NONE RETAINED

Blood specimens, serum, non-retained

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ayman Hammoudeh, MD

  Istishari Hospital Amman

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2012
• First Posted: June 8, 2012
• Study Start: August 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: June 8, 2012

Record last verified: 2012-06