Comparing anti-hypertensive combination therapy of fixed dose losartan and hydrochlorothiazide(HCTZ) versus angiotensin receptor blocker(ARB) and calcium channel blocker(CCB) on hypertensive patients whose blood pressures don't lower enough,effect and influence of metabolic system trial.

Comparing anti-hypertensive combination therapy of fixed dose losartan and hydrochlorothiazide(HCTZ) versus angiotensin receptor blocker(ARB) and calcium channel blocker(CCB) on hypertensive patients whose blood pressures don't lower enough,effect and influence of metabolic system trial. - Effects of Losartan and diUretics Combination therapy on Intensive blood pressure control and DiAbetic Tolerance in East-Saitama(ELUCIDATE)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001692

Enrollment

300

Registered

2009-02-06

Start date

2009-03-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Hypertension

Interventions

Fixed dose of Losartan/HCTZ group ARB and CCB combination group

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Hypertensive patients, who have been previously treated with monotherapy of an ARB for more than 4 weeks, however, whose blood pressure has not been reached the target defined by the JSH2009 criteria. 2) Men and women aged from 20 to 85 years 3) Outpatients 4) Patients who fully understand the study procedures explained to them using explanatory notes and have given written informed consent to participate in the study

Exclusion criteria

Exclusion criteria: 1)Patients with uncontrolled diabetes (HbA1c more than 9.0%) 2) Patients with secondary hypertension 3)Patients who have stroke, AMI and/or other critical vascular complications that required hospitalization within 24 weeks prior to the intervention 4)Patients with liver dysfunction [GPT(ALT) over three times the normal value] 5)Patients with renal failure (serum creatinine more than 2.0 mg/dL) 6)Patients with uncontrolled hyperuricemia (more than 9.0mg/dL) 7)Patients with cardiac insufficiency (more than NYHA grade III) 8) Patients with severe malignant cancer or other unfavorable prognostic factors 9)Pregnant or possible pregnant women 10)Patients with a history of hypersensitivity to ingredients of losartan potassium or hydrochlorothiazide 11)Patients with a history of hypersensitivity to thiazide or thiazide-like diuretics 12)Patients who are considered not eligible for the study by the attending doctor due to medical reasons

Design outcomes

Primary

Measure	Time frame
Changes in blood pressure after 8 weeks. The achievement rate of the blood pressure target level(JSH criteria)after 8 weeks	—

Secondary

Measure	Time frame
Inhibitory effect of development of diabetes. The rate of new-onset diabetes. Change in blood pressure,blood glucose,HbA1c,high-molecular weight adiponectin,hs-CRP,BNP,urinary microalbuminuria. Safty	—

Countries

Japan

Contacts

Public ContactYoshimasa Aso

Koshigaya Hospital,Dokkyo Medical University Department of Internal Medicine

yaso@dokkyomed.ac.jp048-965-8253

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026

Comparing anti-hypertensive combination therapy of fixed dose losartan and hydrochlorothiazide(HCTZ) versus angiotensin receptor blocker(ARB) and calcium channel blocker(CCB) on hypertensive patients whose blood pressures don&#39;t lower enough,effect and influence of metabolic system trial.