Cardiovascular (CV) Risk Evaluation In Type 2 Diabetes Subjects

October 13, 2008 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment

1100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Study Registration Dates

First Submitted

March 27, 2008

First Submitted That Met QC Criteria

March 31, 2008

First Posted (Estimate)

April 1, 2008

Study Record Updates

Last Update Posted (Estimate)

October 15, 2008

Last Update Submitted That Met QC Criteria

October 13, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

104243
Avandia OB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.