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: UMIN000001436

Registered date:20/10/2008

Basic Information

• Recruitment status: Complete: follow-up continuing
• 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 50mg+HCT 12.5mg
Losartan 100mg or Candesartan 12mg or Valsartan 160mg or Telmisartan 80mg or Olmesartan 40mg

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: - 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. -

Related Information

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