Hypertension with Diabetes mellitus
Conditions
Interventions
Losartan 50mg+HCT 12.5mg
Losartan 100mg or Candesartan 12mg or Valsartan 160mg or Telmisartan 80mg or Olmesartan 40mg
Sponsors
SIMPL OSAKA INVESYGATORS (Masatsugu Hori)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Hypertensive 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 the five ARB monotherapy (either Losartan 50mg, Candesartan 8mg, Valsartan 80mg, Telmisartan 40mg, Olmesartan 20mg) at least 3 months. - Patients has SBP>130mmHg and/or DBP 80mmHg. - Patients has HbA1c>5.8%, or FBS>110mg/dL, or BS>140mg/dL. 2) Patients withage 30to 74 years old. 3) Both gender is included. 4) In and out patients. 5) Male patients with SCr<1.5mg/dL and Female patients with SCr<1.2mg/dL. 6) Patientsb with microalbuminuria in the last 6 months. 7) Patients who understands study prodcedures and agrees to participate in the study by giving written informed concent prior to the study start.
Exclusion criteria
Exclusion criteria: - Patients with IDDM - Patients with nephropathy(UACR>300mg/dL). - Patients with HbA1c>10%. - Patients with insulin treatment. - Patients with poor controlled hypertension (SBP>180mmHg and DBP>110mmHg) - Patients with a critical liver disease (ALT or AST is over 3 times of normal values). - Patients with gout. - Patients with any severe cardiovascular events with hospitalization within the 6 months proior to informed concent. - Patients is pregnant or brest feeding or is a femele expecting conceive within the projected duration of the study. - Patients with secondary hypertension. - Patients with non-diabetic renaldisaeses such as glomerulonaphritis or polycystic kidney eta. - Patients with heart failure (above NYHA III) - Patients with poor controlled arythmia. - Patients treated with diuretics. - Patients has allagy against therapy drugs. - Patients who are considered to be not eligible to thye study by the investigator due to medical reason. -
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 &#8211; 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
Outcome results
None listed