Clinical study on anti-atherosclerotic effect of azelnidipine/amlodipine in the hypertensive patients with type 2 diabetes

UMIN ID: UMIN000000495

Registered date:01/01/2007

Basic Information

• Health condition(s) or Problem(s) studied: Hypertension
• Date of first enrollment: 2006/10/01
• Target sample size: 150
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Randomided after 4 weeks administration of 20mg of olmesartan. 16mg of azelnizipine is administered for 8 weeks after randomization
Randomided after 4 weeks administration of 20mg of olmesartan. 5mg of amlozipine is administered for 8 weeks after randomization
20mg of olesartan is administered for 12 weeks

Outcome(s)

• Primary Outcome: fasting plasma glucose, insulin HbA1c T-Chol, HDL-C, LDL-C, TG hs-CRP, HM-adiponectine nitrotyrosine, urinary 8-isoprostan
• Secondary Outcome: home or clinic blood pressure

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1. Patients using insulin 2. Patients with secondary hypertension 3. Patients on hemodialysis 4. Pregnant women or those who plan pregnancy 5. Patients with history of hypersensitivity to olmesartan, azelnizipine, amlodipine 6. Patients with severe liver injury 7. Patients with severe renal failure (serum CRE>=3.0mg/dl) 8. Other patients judged unsuitable for the study by investigator

Related Information

• Primary Sponsor: Advanced Medicine Study Group in Kyushu Island
• Source(s) of Monetary Support: none