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

Not Applicable

• Conditions: Hypertension with Diabetes mellitus

• Registration Number: JPRN-UMIN000001436
• Lead Sponsor: SIMPL OSAKA INVESYGATORS (Masatsugu Hori)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-10-20
• Study Completion: 2011-03-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
- 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