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Clinical study about the hypotensive effect and the inhibitory effect on the elevation of uric acid level by irbesartan and trichlormethiazide in the essential hypertensive patients.

Not Applicable
Completed
Conditions
Hypertension
Registration Number
JPRN-jRCT1090220183
Lead Sponsor
agoya Medical Association
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
100
Inclusion Criteria

Essential hypertensive patients who have been taking ARB except irbesartan (IrbetanR) and losartan and concomitantly with trichlormethiazide (FluitranR) 1 mg, and have not changed these medications at least for 8 weeks,
whose systolic blood pressure (BP) or diastolic BP at baseline is >=130 or >=80 mmHg respectively and also who signed on informed consent to participate in this study.

Exclusion Criteria

Patients with severe hypertension (diastolic BP >=120 mmHg), secondary or malignant hypertension. Patients with recent history of myocardial infarction or stroke within 6 months.
Patients with severe hepatic dysfunction (AST >=100 IU/L or ALT >=100 IU/L or bilirubin >=2.5 mg/dL),or with renal dysfunction (serum creatinine >=2.0 mg/dL or e-GFR<30 mL/min/1.73 m2), or type 1 diabetes mellitus, or poorly controlled type 2 diabetes mellitus.
Patients with drug or alcohol abuse. Patients who are pregnant or breastfeeding.
Patients under participation in other clinical trials.
Patients with history of hypersensitivity to irbesartan (IrbetanR) and trichlormethiazide (FluitranR)
Patients who took some concomitant drugs prohibited during the previous 8 weeks before the start of study.
Patients who are deemed ineligible by investigator.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Primary outcome: percent changes of blood pressure from 0 week(baseline) to 12 weeks
Secondary Outcome Measures
NameTimeMethod
Secondary outcome: Changes of serum uric acid from 0 week(baseline) to 12 weeks
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