Hypertension with diabetes mellitus
Conditions
Interventions
Losartan 50 mg/HCTZ 12.5 mg
maximum dose of ARBs
Sponsors
SIMPL OSAKA Investigators
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Hypertension patients with diabetes mellitus who has previously been treated with ARB and whose blood pressure has not been adequately controlled with the treatment. Patients has received one of five ARB monotherapyies (either Losartan 50mg, Candesartan 8mg, Valsartan 80mg, Telmisartan 40mg, or Olmesartan 20mg) at least for 3 months. Patients has SBP less than 130mmHg, and/or DBP more than 80mmHg Patients has HbA1c more than 5.8% (FBS more than 110mg/dl or BS more than140mg/dl) in present or past or been previously treated with diabetetic medication. 2. Patients of between 30 and 74 years of age. 3. Both gender is included. 4. In and out patients 5. Male patients with SCrless than1.5mg/dl, and female patients with SCr less than 1.2mg/dl 6. Patients with microalbuminuria data in last 6 months. 7. Patients who understands study procedures and agree to participate in the study by giving written informed consent prior to the study start.
Exclusion criteria
Exclusion criteria: 1. Patients with IDDM 2. Patients with nephropathy (urinary albumin-to-creatinine ratio is more than 300mg/gCr). 3. Patients with poor controlled diabetes mellitus (HbA1c more than 10%) 4. Patients with insukin treatment 5. Patients with poor controlled hypertension (SBP more than 180mmHg or DBP more than 110mmHg) 6. Patients with malignant hypertension 7. Patients with critical liver damage. (ALT or AST is over 3 times of normal) 8. Patients with attack of gout 9. Patients has had any severe cardiovascular events with hospitalization within the 6 months prior to informed consent. 10. Patients is pregnant or breast feeding; or is a female expecting to conceive within the projected duration of the study. 11. Patients with the secondary hypertension. 12. Patients with non-diabetic nephropathy such as chronic glomerulonephritis. polycystic kidney disease. reniculus 13. Patients with heart failure 14. Patients has poor controlled arrhythmia. 15. Patients has treated with diuretics. 16. Patients has allergia of test drugs 17. Patients who are considered not to be negligible to the study by the investigator due to medical reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changing value of SBP in three-month period within 2 groups Prevention of progress of diabetes nephrology in all trial period within 2 groups | — |
Secondary
| Measure | Time frame |
|---|---|
|  Microalbuminuria, hs-CRP, eGFR and BNP change in 3, 6, 12, 18 and 24-month period within 2 groups.  Cost of antihypertensive medications.  Composite endpoint – All cause death, AMI, unstable angina, CABG, PCI, hospitalization of CHF, Stroke, major vascular events.  Echocardiographic evaluation (LVMI, E/A and EF), cystatin C and HOMA-R change in 12, 24-month period within 2 groups  The safety of Losartan 50 mg/HCTZ 12.5 mg and maximum dose of ARBs | — |
Countries
Japan
Contacts
Public ContactMasatsugu Hori
Osaka Medical Center for Cancer and Cardiovascular Diseases President
Outcome results
None listed