A randomized controlled study to compare the effects of angiotensin II type 1 receptor blockers (telmisartan vs candesartan vs valsartan) on the markers of cardiovascular risk in hypertensive patients with type 2 diabetes mellitus

UMIN ID: UMIN000001689

Registered date:05/02/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Hypertension with type 2 diabetes mellitus
• Date of first enrollment: 2005/04/01
• Target sample size: 300
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Telmisartan will be prescribed at 40 mg/day for 12 weeks.
Candesartan will be prescribed at 8mg/day for 12 weeks.
Varsartan will be prescribed at 80mg/day for 12 weeks.

Outcome(s)

• Primary Outcome: 1. changes in adipocytokines 2. changes in high-sensitivity CRP 3. changes in PAI-I
• Secondary Outcome: 1. changes in blood pressure levels measured on an outpatient basis 2. changes in blood pressure levels at home 3. changes in HOMA-R(fasting glucose, fasting insulin) 4. changes in HbA1c 5. changes in serum lipids levels (cholesterol, triglycerides, HDL cholesterol, FFA) 6. changes in urinary albumin levels

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1. Patients being prescribed pioglitazone 2. Patients being treated with insulin 3. Patients with severe hepatic dysfunction 4. Patients with severe renal dysfunction 5. Patients with severe infection or severe injury 6. Patients requiring operative treatment 7. Patients with a past history of hypersensitiveness to these drugs 8. Pregnant and probably pregnant patients 9. Other patients judged as being inappropriate for the subjects of the study investigators

Related Information

• Primary Sponsor: Department of Endocrinology and DiabetesNagoya University Graduate School of Medicine
• Source(s) of Monetary Support: none