Text Size

Cardiovascular (CV) Risk Evaluation In Type 2 Diabetes Subjects

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00648284
First received: March 27, 2008
Last updated: October 13, 2008
Last verified: October 2008
History of Changes
  Purpose

The primary objective of this study is to assess the total CV risk in patients with type 2 diabetes and also to assess the impact of rosiglitazone in the total CV risk and the parameters of metabolic syndrome.


Condition
Type 2 Diabetes Mellitus
CV Risk

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: An Observational Study to Assess the Impact of Pharmacological Intervention and Life Style Changes in the Reduction of Cardiovascular Disease in Patients With Diabetes Type 2 in Greece

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Estimated Enrollment: 1100
Study Start Date: March 2004
  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients with diabetes type 2 that their physician has decided to prescribe AVANDIA for better control of their condition
  • Have signed informed consent

Exclusion Criteria:

  • Patients with ALT > 2.5x the normal value
  • With heart failure symptoms
  • With diagnosis of angina pectoris or stable angina demanding continuous treatment with nitrates
  • With recent myocardial infarction (<6 months)
  • With severe renal disfunction
  • Pregnant or lactating or planned to be pregnant during the study
  • Under investigational drug treatment
  • Alcoholic or drug abuser
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00648284

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00648284     History of Changes
Other Study ID Numbers: 104243, Avandia OB
Study First Received: March 27, 2008
Last Updated: October 13, 2008
Health Authority: Greece: National Organization of Medicines

Keywords provided by GlaxoSmithKline:
Type 2 diabetes
CV risk
rosiglitazone
AVANDIA

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
 Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013