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Completed

NCT Number: NCT01614561

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

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.

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Key information

About this study

CEPHEUS Centralized Pan-Levant Survey on the Undertreatment of Hypercholesterolemia NIS-LT-CRE-2010/01 Version 1.0

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

    Time frame: 5 months- One visit only, no follow up visits

Secondary outcomes

  1. 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

    Time frame: 5 months- One visit only, no follow up visits

  2. 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

    Time frame: 5 months- One visit only, no follow up visits

  3. 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.

    Time frame: 5 months- One visit only, no follow up visits

  4. 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

    Time frame: 5 months- One visit only, no follow up visits

  5. Physician characteristics associated with the allocation of treatment regimen.

    Time frame: 5 months- One visit only, no follow up visits

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

CEPHEUS Centralized Pan-Levant Survey on the Undertreatment of Hypercholesterolemia NIS-LT-CRE-2010/01 Version 1.0

Acronym: CEPHEUS

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 8, 2012
Registry last updated
Jun 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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