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Centralised Pan-Algerian Survey on the Undertreatment of Hypercholesterolemia (CEPHEUS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01768403
First received: January 14, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

Centralized Pan-Algerian Survey on the undertreatment of hypercholesterolemia. The purpose of this study is to establish the proportion of patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the Third Joint European Task Force guidelines in the survey population.


Condition
Hypercholesterolemia
Cardiovascular Disease
Hypertension
Diabetes
Coronary Heart Disease
Peripheral Arterial Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Centralised Pan-Algerian Survey on the Undertreatment of Hypercholesterolemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Number and percentage of subjects achieving the LDL-C goals, according to the Third Joint European Task Force (TJETF) guidelines. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number and percentage of subjects achieving LDL-C goals according to the TJETF guidelines. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    In the following sub-populations: - Patients with / or not with metabolic syndrome (according to NCEP III definition), - Primary/secondary prevention patients

  • Number and percentage of subjects achieving LDL-C goals according to the NCEP ATP III/2004 updated NCEP ATP III and to the 2005 AFSSAPS guidelines [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Overall and in the following sub-populations: Patients with/or without metabolic syndrome-Iary/IIary preven

  • Number and percentage of subjects achieving LDL-C goals according to the : TJETF / NCEP ATP III and 2004 updated NCEP ATP III guidelines. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    For the following sub-populations: Demographic variables, CV risk factors & Lipid-lowering agent class

  • The association between achievement of LDL-C goals, according to the Third Joint European Task Force / NCEP ATP III / 2004 updated NCEP ATP III guidelines, and patient and physician variables, assessed by multivariate logistic regression models [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Whole blood serum


Enrollment: 1236
Study Start Date: September 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Detailed Description:

Centralised Pan-Algerian Survey on the undertreatment of hypercholesterolemia.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  • Subject must be 19 years of age or older of either gender or race.
  • Subject must provide informed consent and comply with the survey procedures.
  • Subject is on lipid lowering drug treatment for at least 3 months, with no dose change for a minimum of 6 weeks
Criteria

Inclusion Criteria:

  • Subject must provide informed consent and comply with the survey procedures.
  • Subject is on lipid lowering drug treatment for at least 3 months, with no dose change for a minimum of 6 weeks.

Exclusion Criteria:

- Subjects who are unwilling or unable to provide informed consent.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01768403

Sponsors and Collaborators
AstraZeneca
Investigators
Study Chair: Habib BENNACEUR, MD AstraZeneca
Study Director: Nawel BOUTEKDJIRET, MD AstraZeneca
Principal Investigator: Yassin BOUHOUITA-GUERMECH, Professor Cardiology department /Mustapha Bacha Hospital
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01768403     History of Changes
Other Study ID Numbers: NIS-CDZ-XXX-2012/1
Study First Received: January 14, 2013
Last Updated: January 14, 2013
Health Authority: Algeria: Ministry of Health

Keywords provided by AstraZeneca:
Hypercholesterolemia
Cardiovascular disease
Hypertension
Coronary Heart disease
Peripheral Arterial disease

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Hypercholesterolemia
Hypertension
Peripheral Arterial Disease
Peripheral Vascular Diseases
 Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atherosclerosis

ClinicalTrials.gov processed this record on May 22, 2013