UMIN ID: UMIN000001470
Registered date:01/11/2008
Therapeutic effects of telmisartan and irbesartan on hypertensive patients with overt diabetic nephropathy
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Hypertension, type 2 diabetes, diabetic nephropathy |
| Date of first enrollment | 2008/11/01 |
| Target sample size | 60 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Telmisartan group: Start with once-daily dosing of telmisartan 20 mg daily for 24 weeks, and dosage may be modulated accroding to the clinical parameters (telmisartan 20-80 mg daily). Target blood pressure level is below 130/80 mmHg. Irbesartan group: Start with once-daily dosing of irbesartan 50 mg daily for 24 weeks, and dosage may be modulated accroding to the clinical parameters (irbesartan 50-200 mg daily). Target blood pressure level is below 130/80 mmHg. |
Outcome(s)
| Primary Outcome | 1. Clinic blood pressure. 2. Ambulatory blood pressure monitoring: mean blood pressure, day-night variation, short-term blood pressure/heart rate variability, LF/HF. 3. Renal function: eGFR, urinary protein/albuminon excretion, urinary urea nitrogen, urinary type 4 collagen. 4. Glucose metabolism: fasting blood glucose, fasting IRI, HOMA-IR. 5. Lipid metabolism: total cholesterol, LDL, HDL, TG. 6. Renin-angiotensin system, inflammatory and oxidative stress markers: PRA, Urinary angiotensinigen, HMW-adiponectin, AGE, MDA-LDA, ADMA, cathecholamine. 7. Vascular function: ABI/baPWV. |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. Pregnant women, or women suspected of being pregnant 2. Hyperkalemia 3. History of hypersensitivity to Telmisartan or Irbesartan 4. Severe liver disorder, or severe biliary atresia. 5. Severe hypertension (clinic BP more than 180/100 mmHg). |
Related Information
| Primary Sponsor | Department of Cardiorenal Medicine, Yokohama City University School of Medicine |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Department of Cardiorenal Medicine, Yokohama City University School of Medicine |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Kazukai Uchino |
| Address | 3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, JAPAN Japan |
| Telephone | 045-787-2634 |
| tamukou@med.yokohama-cu.ac.jp | |
| Affiliation | Yokohama City University Graduate School of Medicine Department of Medical Science |
| scientific contact | |
| Name | Kouichi TAMURA |
| Address | 3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, JAPAN Japan |
| Telephone | 045-787-2635 |
| tamukou@med.yokohama-cu.ac.jp | |
| Affiliation | Yokohama City University Graduate School of Medicine Department of Cardiorenal Medicine |