NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000000495

Registered date:01/01/2007

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

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedHypertension
Date of first enrollment2006/10/01
Target sample size150
Countries of recruitmentJapan
Study typeInterventional
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 Outcomefasting plasma glucose, insulin HbA1c T-Chol, HDL-C, LDL-C, TG hs-CRP, HM-adiponectine nitrotyrosine, urinary 8-isoprostan
Secondary Outcomehome or clinic blood pressure

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
GenderMale and Female
Include criteria1. Patients with type2 diabetes 2. Patients with hypertension 3. Outpatient
Exclude criteria1. 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

Contact

public contact
Name Masanari Mizuta
Address 5200 Kihara, Kiyotake, Miyazaki 889-1692, Japan Japan
Telephone 0985-85-2965
E-mail mmizuta@fc.miyazaki-u.ac.jp
Affiliation University of Miyazaki Faculty of Medicine Division of Endocrinology and metabolism, Department of Medicine
scientific contact
Name Prof. Masamitsu Nakazato
Address 5200 Kihara, Kiyotake, Miyazaki 889-1692, Japan Japan
Telephone 0985-85-2965
E-mail
Affiliation University of Miyazaki Faculty of Medicine Division of Endocrinology and metabolism, Department of Medicine