Diabetic Under 70 (Diabetics Below 70)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00516204
First received: August 14, 2007
Last updated: October 29, 2014
Last verified: October 2014
  Purpose

A screening project of diabetics with a very high cardiovascular risk (e.g. diabetes plus coronary heart disease) who already receive cholesterol-lowering therapy. Lipid profile and rate of patients who are treated to target (which is <70mg/dl for such patients with very high risk) are screened. The doctors therapy decisions after the screening will be documented and 8-10 weeks later the lipid profile of each patient will be evaluated again. Our aim is to evaluate dosing habits, to evaluate how many patients are treated to their LDL-C target and to underline the importance of treating patients to their cholesterol targets.


Condition
Diabetes
Hyperlipidemia
Atherosclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diabetic Under 70 (Diabetics Below 70)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Cholesterol levels [ Time Frame: After 4 weeks ] [ Designated as safety issue: No ]
    Cholesterol levels from high risk patients after 4 weeks of cholesterol-lowering drug therapy under target values


Enrollment: 685
Study Start Date: July 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients at very high risk
Patients at high risk
Patients at medium risk
Patients at low risk

  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

Male and female secondary prevention patients with: coronary disease with event: acute coronary syndrome, status post MI, PTCA, CABG, angiographically verified), PAVK (min. IIb or S.p. revascularization), stroke/TIA, carotis-plaque (asymptomatic min. 70% or S.p. revascularization), Diabetes Mellitus (type I, II)

Criteria

Inclusion Criteria:

  • Diabetics with hyperlipidemia and atherosclerosis (coronary heart disease, carotid stenosis, PAVK, etc.) who already receive cholesterol-lowering therapy

Exclusion Criteria:

  • Diabetics w/o CVD; diabetics who do not receive cholesterol-lowering therapy
  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: NCT00516204

Locations
Austria
Research Site
Vienna, Austria
Sponsors and Collaborators
AstraZeneca
Investigators
Study Chair: Michael Roden, MD Chairs of the Austrian Diabetes Society
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00516204     History of Changes
Other Study ID Numbers: NIS-CAT-CRE-2007/3, NIS-CAT-DUM-2007/3
Study First Received: August 14, 2007
Last Updated: October 29, 2014
Health Authority: Not required for this study:

Keywords provided by AstraZeneca:
Hyperlipidemia
Diabetics
NIS
Diabetics with hyperlipidemia and atherosclerosis (coronary heart disease, carotid stenosis, PAVK, etc.)

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Hyperlipidemias
Arterial Occlusive Diseases
Cardiovascular Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014