The Evaluation of Effects against Acute- or Relapse Infarction in Patients with both Diabetes and Hypertension Taking ARB and PPAR-gammma Inhibitor

UMIN ID: UMIN000001548

Registered date:03/12/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Patients with diabetes and hypertension
• Date of first enrollment: 2008/05/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

In the thiazolidine derivatives group, thiazolidine derivatives will be prescribed as per specifications attached.
In sulfonylurea hypoglycemic agent, the agent will be prescribed as per specifications attached.

Outcome(s)

• Primary Outcome: Primary end-point is time from randomization to first occurrence of any of the events in the following composite: 1. Cardiovascular disturbance 2. Cerebrovascular disease 3. Renal failure 4. Administration of dialysis treatment 5. Cardiac mortality 6. Cerebrovascular mortality
• Secondary Outcome: Secondary end-point is time from randomization to first occurrence of any of the events in the following composite: 1. All-cause mortality 2. Cardiac depression and impairing renal function 3. Progression of diabetes 4. Progression of hypertension

Key inclusion & exclusion criteria

• Age minimum: 40years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1) History of cardiac failure 2) Diagnosis of Cardiovascular disturbance and/or cerebrovascular disease within 6 months 3) Secondary hypertension 4) Type I diabetes 5) Diagnosis and/or treatment of cancer within 5 years 6) Renal dysfunction 7) Liver dysfunction 8) History of side effects of TDZ or ARB 9) No current or past history of psychiatric disorders 10) Pregnant women or lactating mothers 11) Participating another clinical investigation within 3 months 12) Patients judged by the investigator to be unfit to be enrolled into the study

Related Information

• Primary Sponsor: HuBit genomix, Inc.
• Secondary Sponsor: National Cerebral and Cardiovascular Center
• Source(s) of Monetary Support: Japan Heart Foundation