Randomized controlled trail on efficacy and safety of Losartan 50 mg/HCTZ 12.5 mg and Titrated Angiotensin Receptor Blockers (ARBs) in Patients who have Hypertension with Diabetes mellitus

Authors
Category Primary study
Year 2008
INTERVENTION: Losartan 50mg+HCT 12.5mg Losartan 100mg or Candesartan 12mg or Valsartan 160mg or Telmisartan 80mg or Olmesartan 40mg CONDITION: Hypertension with Diabetes mellitus PRIMARY OUTCOME: 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 OUTCOME: ‐ 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 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.
Epistemonikos ID: 56e1da4ee67c6200aa540b58e4c91a9226c5e3b9
First added on: Aug 21, 2024