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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00419484
Other study ID # 0309
Secondary ID
Status Completed
Phase Phase 4
First received January 5, 2007
Last updated January 5, 2007
Start date March 2004
Est. completion date July 2008

Study information

Verified date January 2007
Source Dokkyo Medical University
Contact n/a
Is FDA regulated No
Health authority Japan: Institutional Review Board
Study type Observational

Clinical Trial Summary

We want to investigate the effects of pioglitazone on cardiovascular events in Japanese patients with type 2 diabetes.


Description:

Primary composite endpoints:

Cardiovascular death Non-fatal myocardial infarction and angina Non-fatal stroke Renal failure (hemodialysis/doubling of serum creatinine)

Secondary endpoints:

urinary albumin excretion diabetic retinopathy hyperlipidemia hypertension gout


Recruitment information / eligibility

Status Completed
Enrollment 1000
Est. completion date July 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria:

- type 2 diabetes HbA1c: more than 7% and less than 9%

Exclusion Criteria:

- insulin treatment

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal


Intervention

Drug:
pioglitazone


Locations

Country Name City State
Japan Dokkyo Medical University, Koshigaya Hospital Koshigaya Saitama

Sponsors (1)

Lead Sponsor Collaborator
Dokkyo Medical University

Country where clinical trial is conducted

Japan, 

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