Comparison of Efonidipine/Irbesartan combination and Irbesartan monotherapy for uncontrolled hypertension

UMIN ID: UMIN000002242

Registered date:01/09/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Hypertension
• Date of first enrollment: 2009/10/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

200mg Irbesartan od
100mg irbesartan + 40mg efonidipine od

Outcome(s)

• Primary Outcome: blood pressure lowering after 1 month
• Secondary Outcome: 1. blood pressure lowering after 6 months 2. Change in albuminuria after 6 months 3. adverse events

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1. pregnant patients 2. patients with severe liver dysfunction 3. patients with severe renal dysfunction 4. allergic to irbesartan or efonidipine 5. patients judged to be inappropriate for this study by attending physicians

Related Information

• Primary Sponsor: Kyoto University Hospital
• Secondary Sponsor: Kyoto University Hospital, Shiga University, Toyama University, Hiroshima University, Kobe City Medical Center General Hospital
• Source(s) of Monetary Support: Coronary circulation funding