- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00419484
Effect of Pioglitazone on Cardiovascular Outcome on Higashi-Saitama Trial in Patients With Type 2 Diabetes
January 5, 2007 updated by: Dokkyo Medical University
We want to investigate the effects of pioglitazone on cardiovascular events in Japanese patients with type 2 diabetes.
Study Overview
Status
Completed
Intervention / Treatment
Detailed 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
Study Type
Observational
Enrollment
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Saitama
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Koshigaya, Saitama, Japan, 343-8555
- Dokkyo Medical University, Koshigaya Hospital
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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
20 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- type 2 diabetes HbA1c: more than 7% and less than 9%
Exclusion Criteria:
- insulin treatment
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
Investigators
- Principal Investigator: Yoshimasa Aso, MD, Dokkyo Medical University, Koshigaya Hospital
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 Completion
July 1, 2008
Study Registration Dates
First Submitted
January 5, 2007
First Submitted That Met QC Criteria
January 5, 2007
First Posted (Estimate)
January 8, 2007
Study Record Updates
Last Update Posted (Estimate)
January 8, 2007
Last Update Submitted That Met QC Criteria
January 5, 2007
Last Verified
January 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Kidney Diseases
- Urologic Diseases
- Endocrine System Diseases
- Diabetes Complications
- Diabetes Mellitus
- Lipid Metabolism Disorders
- Diabetes Mellitus, Type 2
- Diabetic Nephropathies
- Dyslipidemias
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Pioglitazone
Other Study ID Numbers
- 0309 (Klein Buendel, Inc.)
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.
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