Clinical study to investigate the effects of olmesartan and azelnidipine in patients with hypertesnion and arteriosclerosis obliterans

UMIN ID: C000000236

Registered date:01/01/2008

Basic Information

• Health condition(s) or Problem(s) studied: Patients with essential hypertension and arteriosclerosis obliterans(ASO)
• Date of first enrollment: 2005/08/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Olmesartan medoxomil will be administered during the study for one year.
Azelnidipine will be administered during the study for one year.

Outcome(s)

• Primary Outcome: Efficacy Changes from baseline in blood pressure (Casual blood pressure and ABPM) Changes from baseline in intima media thickness in femoral arteries and carotid arteries Safety Adverse event and laboratory tests

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Fontane classification III or IV 2) Immediate requirement for surgical operation 3) Myocardial infarction, unstable angina pectoris, stroke or transient ischemic atttack within 6 months before giving informed consent 4) Deep-vein thrombosis within 3 months before giving informed consent 5) Malignancy that requires treatment 6) Liver dysfunction (AST and ALT>100IU/L) 7) Renal dysfunction (creatinine>3.0mg/dL)

Related Information

• Primary Sponsor: Cardiovascular Hospital of Central Japan
• Source(s) of Monetary Support: Cardiovascular Hospital of Central Japan