Centralized Pan-Russian Survey on the Undertreatment of Hypercholesterolemia (CEPHEUS)
This study has been completed.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01221584
First received: October 14, 2010
Last updated: February 29, 2012
Last verified: February 2012
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Purpose
The purpose of the study is to establish the proportion of patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the All-Russian Scientific Cardiology Society guidelines/ the 4th Joint European Task Force guidelines.
| Condition |
|---|
|
Dyslipidaemia |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Centralized Pan-Russian Survey on the Undertreatment of Hypercholesterolemia |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Establish the proportion of patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the All-Russian Scientific Cardiology Society guidelines/the Fourth Joint European Task Force guidelines [ Time Frame: 1 visit - 1-3 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Establish the proportion of patients on lipid-lowering treatment reaching the LDL-C goals according to the Russian guidelines in the following sub-populations: Primary/secondary prevention patients, Patients with metabolic syndrome [ Time Frame: 1 visit - 1-3 days ] [ Designated as safety issue: No ]
- Establish the proportion of patients on lipid-lowering treatment reaching the LDL-C goals according to the FJETF/ NCEP ATP III guidelines, in all population and in Primary/secondary prevention patients, Patients with metabolic syndrome [ Time Frame: 1 visit - 1-3 days ] [ Designated as safety issue: No ]
- Establish 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 guidelines in the sub-population patients with fasting triglycerides >200 mg/dL (2.26mmol/L) [ Time Frame: 1 visit - 1-3 days ] [ Designated as safety issue: No ]
| Enrollment: | 1000 |
| Study Start Date: | October 2010 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
Subject 18 years of age or older on lipid lowering drug treatment for at least 3 months, with no dose change for a minimum of 6 weeks..
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Subject 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 be 18 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.
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: NCT01221584
Locations
| Russian Federation | |
| Research Site | |
| Krasnodar, Russian Federation | |
| Research Site | |
| Moscow, Russian Federation | |
| Research Site | |
| Nizhniy Novgorod, Russian Federation | |
| Research Site | |
| Novosibirsk, Russian Federation | |
| Research Site | |
| Saint-Petersburg, Russian Federation | |
| Research Site | |
| Samara, Russian Federation | |
| Research Site | |
| Voronezh, Russian Federation | |
| Research Site | |
| Yaroslavl, Russian Federation | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Alexey Stepanov, Prof | AstraZeneca |
| Principal Investigator: | Prof. Boytsov | RKNPK |
| Principal Investigator: | Acad Oganov | Center of preventive medicine |
More Information
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01221584 History of Changes |
| Other Study ID Numbers: | NIS-CRU-DUM-2010/1 |
| Study First Received: | October 14, 2010 |
| Last Updated: | February 29, 2012 |
| Health Authority: | Russia: Ethics Committee |
Keywords provided by AstraZeneca:
|
Dyslipidaemia LDL-C goals guidelines |
Additional relevant MeSH terms:
|
Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 21, 2013