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Diabetic Under 70 (Diabetics Below 70)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00516204
First Posted: August 15, 2007
Last Update Posted: October 30, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  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)

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Cholesterol levels [ Time Frame: After 4 weeks ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00516204     History of Changes
Other Study ID Numbers: NIS-CAT-CRE-2007/3
NIS-CAT-DUM-2007/3
First Submitted: August 14, 2007
First Posted: August 15, 2007
Last Update Posted: October 30, 2014
Last Verified: October 2014

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

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