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

UMIN ID: UMIN000001563

Registered date:10/12/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Hypertension with diabetes mellitus
• Date of first enrollment: 2008/02/01
• Target sample size: 300
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Losartan 50 mg/HCTZ 12.5 mg
maximum dose of ARBs

Outcome(s)

• 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 – 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

Key inclusion & exclusion criteria

• Age minimum: 30years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: SIMPL OSAKA Investigators
• Source(s) of Monetary Support: Japan Heart Foundation