Dyslipidemia Clinical Trial
— CEPHEUSOfficial title:
Centralized Pan-Bulgarian Survey on the Undertreatment of Hypercholesterolemia
Verified date | September 2010 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | Bulgaria: Bulgarian Drug Agency |
Study type | Observational |
The purpose of this study is to establish the proportion of Bulgarian patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the Fourth Joint European Task Force guidelines.
Status | Completed |
Enrollment | 2500 |
Est. completion date | August 2010 |
Est. primary completion date | August 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Lipid lowering drug treatment for at least 3 months, with no dose change for a minimum of 6 weeks - Signed Informed Consent Exclusion Criteria: - Informed Consent not provided |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Bulgaria | Research Site | Blagoevgrad | |
Bulgaria | Research Site | Burgas | |
Bulgaria | Research Site | Haskovo | |
Bulgaria | Research Site | Montana | |
Bulgaria | Research Site | Pazardjik | |
Bulgaria | Research Site | Pleven | |
Bulgaria | Research Site | Plovdiv | |
Bulgaria | Research Site | Russe | |
Bulgaria | Research Site | Shumen | |
Bulgaria | Research Site | Sliven | |
Bulgaria | Research Site | Smolyan | |
Bulgaria | Research Site | Sofia | |
Bulgaria | Research Site | Stara Zagora | |
Bulgaria | Research Site | Varna | |
Bulgaria | Research Site | Veliko Turnovo |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Bulgaria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The number and percentage of patients achieving the LDL-C goals, according to the Fourth Joint European Task Force guidelines | 6 months - one visit only, no follow-up visits | No | |
Secondary | The number and percentage of subjects achieving the LDL-C goals, according to the Fourth Joint European Task Force guidelines for several subject subsets | 6 months - one visit only, no follow-up visits | No | |
Secondary | The number and percentage of subjects achieving LDL-C goals according to the NCEP ATP III / 2004 updated 2004 NCEP ATP III guidelines, overall and for several subject subsets | 6 months - one visit only, no follow-up visits | No | |
Secondary | The number and percentage of subjects achieving the non HDL-C goals according to the NCEP ATP III/updated 2004 NCEP ATP III/national guidelines [<130mg/dL (3,37mmol/L)], in the following sub-population: patients with fasting triglycerides >200 mg/dL | 6 months - one visit only, no follow-up visits | No |
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