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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00724542
Other study ID # 2006BAI01A02-11
Secondary ID
Status Recruiting
Phase N/A
First received July 25, 2008
Last updated August 22, 2008
Start date July 2008
Est. completion date December 2010

Study information

Verified date August 2008
Source Ministry of Science and Technology of the People´s Republic of China
Contact Wenhui Ding, Professor
Phone 86-10-66551122
Email dwh_rd@126.com
Is FDA regulated No
Health authority China: Ministry of Health
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether therapeutic intervention on impaired glucose tolerance in patients with coronary heart disease can decrease the incidence of new onset DM.


Recruitment information / eligibility

Status Recruiting
Enrollment 1600
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 75 Years
Eligibility Inclusion Criteria:

- Patients with coronary heart disease

- Impaired Glucose Tolerance

Exclusion Criteria:

- Age < 40yr or > 75yr

- Diabetes Mellitus

- Scr > 2.0 mg/dL(176 µmol/L)

- ALT or AST > 2.5 ULN

- Hb < 90g/L

- Heart Failure

- Infection

- Undergo other interventional clinical trial

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Intervention

Drug:
Voglibose tablets
0.2mg Tid

Locations

Country Name City State
China Peking University First Hospital Beijing Beijing

Sponsors (2)

Lead Sponsor Collaborator
Ministry of Science and Technology of the People´s Republic of China Takeda

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Type?Diabetes Mellitus 2 years Yes
Secondary Occurrence of Cardiovascular Events 2 years Yes
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