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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01614561
First received: June 1, 2012
Last updated: June 6, 2012
Last verified: June 2012
  Purpose

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.


Condition
High Blood Cholesterol

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: CEPHEUS Centralized Pan-Levant Survey on the Undertreatment of Hypercholesterolemia NIS-LT-CRE-2010/01 Version 1.0

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Physician characteristics associated with the allocation of treatment regimen. [ Time Frame: 5 months- One visit only, no follow up visits ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Blood specimens, serum, non-retained


Enrollment: 1000
Study Start Date: August 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients attending out patient clinics in Jordan and Lebanon

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01614561

Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Ayman Hammoudeh, MD Istishari Hospital Amman
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01614561     History of Changes
Other Study ID Numbers: NIS-LT-CRE-2010/01
Study First Received: June 1, 2012
Last Updated: June 6, 2012
Health Authority: Jordan: Ethical Committee
Lebanon: Ministry of Public Health

Keywords provided by AstraZeneca:
Hypercholesterolemia
Lipid lowering drugs
Cholesterol level in blood
Target cholesterol levels guidelines for the management of high blood cholesterol

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014