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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610001024033

Enrollment

Registered

2010-11-23

Start date

2007-01-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

The study was performed by daily oral administration of losartan/hydrochlorothiazide combined tablet for 3 months. The doses of losartan/hydrochlorothiazide were fixed throughout the study at 50mg/12.5mg/day. This study was designed as a cross-over study. We did not have the washout period.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

20 Years to 75 Years

Healthy volunteers

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.

Outcome results