NCT01075594

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2010

Shorter than P25 for all trials

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 25, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

September 10, 2010

Status Verified

September 1, 2010

Enrollment Period

6 months

First QC Date

February 19, 2010

Last Update Submit

September 9, 2010

Conditions

Keywords

DyslipidemiaTarget cholesterolUndertreatment

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (1)

1

Patients with dyslipidemia on lipid lowering therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Primary care clinic

You may qualify if:

  • Lipid lowering drug treatment for at least 3 months, with no dose change for a minimum of 6 weeks
  • Signed Informed Consent

You may not qualify if:

  • Informed Consent not provided

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Research Site

Blagoevgrad, Bulgaria

Location

Research Site

Burgas, Bulgaria

Location

Research Site

Haskovo, Bulgaria

Location

Research Site

Montana, Bulgaria

Location

Research Site

Pazardzhik, Bulgaria

Location

Research Site

Pleven, Bulgaria

Location

Research Site

Plovdiv, Bulgaria

Location

Research Site

Rousse, Bulgaria

Location

Research Site

Shumen, Bulgaria

Location

Research Site

Sliven, Bulgaria

Location

Research Site

Smolyan, Bulgaria

Location

Research Site

Sofia, Bulgaria

Location

Research Site

Stara Zagora, Bulgaria

Location

Research Site

Varna, Bulgaria

Location

Research Site

Veliko Tarnovo, Bulgaria

Location

Biospecimen

Retention: NONE RETAINED

whole blood, serum

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 19, 2010

First Posted

February 25, 2010

Study Start

February 1, 2010

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

September 10, 2010

Record last verified: 2010-09

Locations