Last updated: 11/03/2018 00:31:36
Cardiovascular (CV) Risk Evaluation In Type 2 Diabetes Subjects
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
1100
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Type 2 Diabetes Mellitus, CV risk
Product
rosiglitazone
Collaborators
Not applicable
Study date(s)
January 2004 to November 2006
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
40 - 80 Years
Accepts healthy volunteers
No
- Inclusion criteria:
- Patients with diabetes type 2 that their physician has decided to prescribe AVANDIA for better control of their condition
Inclusion and exclusion criteria
Inclusion 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
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2006-30-11
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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