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Effect of Pioglitazone on Cardiovascular Outcome on Higashi-Saitama Trial in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00419484
First Posted: January 8, 2007
Last Update Posted: January 8, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Dokkyo Medical University
  Purpose
We want to investigate the effects of pioglitazone on cardiovascular events in Japanese patients with type 2 diabetes.

Condition Intervention Phase
Type 2 Diabetes Hypertension Dyslipidemia Diabetic Nephropathy Drug: pioglitazone Phase 4

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Dokkyo Medical University:

Estimated Enrollment: 1000
Study Start Date: March 2004
Estimated Study Completion Date: July 2008
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • insulin treatment
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00419484


Locations
Japan
Dokkyo Medical University, Koshigaya Hospital
Koshigaya, Saitama, Japan, 343-8555
Sponsors and Collaborators
Dokkyo Medical University
Investigators
Principal Investigator: Yoshimasa Aso, MD Dokkyo Medical University, Koshigaya Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00419484     History of Changes
Other Study ID Numbers: 0309
First Submitted: January 5, 2007
First Posted: January 8, 2007
Last Update Posted: January 8, 2007
Last Verified: January 2007

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Dyslipidemias
Diabetic Nephropathies
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lipid Metabolism Disorders
Kidney Diseases
Urologic Diseases
Diabetes Complications
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs