Effect of Pioglitazone on Cardiovascular Outcome on Higas... | NCT00419484

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

NCT00419484

Sponsor

Dokkyo Medical University

Status

Completed

Last Update Posted

Jan 8, 2007Estimated

Enrollment

1,000

Phase

Not provided

Conditions

Type 2 Diabetes
Hypertension
Dyslipidemia
Diabetic Nephropathy

Interventions

pioglitazone

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2004

Primary Completion Date

Not provided

Completion Date

Jul 2008

First Submitted Date

Jan 5, 2007

First Submission Date that Met QC Criteria

Jan 5, 2007

First Posted Date

Jan 8, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2007

Last Update Posted Date

Jan 8, 2007Estimated

Description Module

Brief Summary

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

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000

Name	Type	Description	Arm Group Labels	Other Names
pioglitazone	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

insulin treatment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yoshimasa Aso, MD	Dokkyo Medical University, Koshigaya Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dokkyo Medical University, Koshigaya Hospital		Koshigaya	Saitama	343-8555	Japan

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2
D006973	Hypertension
D050171	Dyslipidemias
D003928	Diabetic Nephropathies

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077205	Pioglitazone

Ancestor Terms

ID	Term
D045162	Thiazolidinediones
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided