Safety and Benefits of A Tablet Combining Losartan and Hydrochlorothiazide in Hypertensive Patients with Diabetes

Phase 4

Recruiting

• Conditions: diabetic patients with hypertension; Cardiovascular - Coronary heart disease; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12610001024033
• Lead Sponsor: Keio University School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-11-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Diabetic patients who had untreated hypertension or uncontrollable hypertension treated with medications except for renin-angiotensin system (RAS) inhibitors.

Exclusion Criteria

Patients with serious refractory hypertension defined as more than 120 mmHg in diastolic BP, history of acute myocardial infarction, stroke, or any other cardiovascular events within 6 months, heart failure with New York Heart Association (NYHA) grade III, or grade IV, history of gout or hyperuricemia at the beginning of this study, kidney dysfunction defined as a serum creatinine level of more than 2 mg/dl, liver dysfunction defined as a serum transaminase level more than 3 times higher than normal, bilateral renal artery stenosis, secondary, or malignant hypertension, polycystic kidney disease, congenital kidney deformities, solitary kidney, pregnancy or probable pregnancy, history of allergy to the medication in this study, or those considered inappropriate.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum levels of creatinine (Cr), cystatin C, potassium (K), uric acid (UA), total cholesterol (TC), triglyceride (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), glucose, and glycoalbumin (GA), and plasma levels of brain natriuric peptide (BNP), active renin concentrations (ARC), and aldosterone (PAC) were measured in venous blood samples, drawn in the morning after an overnight fast on the same days as the cardio-ankle vascular index (CAVI), augmentation index (AI), and blood pressure (BP) measurements were taken. Timepoints: 3 and 6 months[at 3 and 6 months from baseline]

Secondary Outcome Measures

Name	Time	Method
one[None]