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A comparison of losartan/hydrochlorothiazide vs high-dose angiotensin II receptor blocker(ARB) for uncontrolled hypertensive patients

A comparison of losartan/hydrochlorothiazide vs high-dose angiotensin II receptor blocker(ARB) for uncontrolled hypertensive patients - Kobe Combination therapy of Losartan/hydrochlorothiazide,effect and safty trial(Kobe-CONNECT)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001389
Enrollment
200
Registered
2008-09-30
Start date
2008-10-01
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

Losartan/hydrochlorothiazide group High-dose ARB group

Sponsors

Kobe hypertensive study group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion criteria:1) Hypertensive patients, who have been previously treated with monotherapy of an ARB or ARB and Carcium channel blocker for more than 8 weeks, however, whose blood pressure has not been reached the target defined by the JSH2004 criteria.2) Men and women aged more than 20 years 3) Outpatients4) 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: Exclusion criteria:1) Patients with uncontrolled hypertension (diastolic blood pressure under 110mmHg) 2) Patients with secondary hypertension 3) Patients with uncontrolled diabetes (HbA1c over 8.0%) and under treatment with insulin 4) Patients who have stroke, AMI and/or other critical vascular complications that required hospitalization within 3 months prior to the intervention 5) Patients with liver dysfunction [GPT(ALT) over three times the normal value]6) Patients with renal failure (serum creatinine over 2.0 mg/dL)7) Patients with a previous history of gout attack or uncontrolled hyperuricemia (over 8.0mg/dL)8) Patients with cardiac insufficiency (NYHA grade III )9) Patients with severe malignant cancer or other unfavorable prognostic factors10) Pregnant or possible pregnant women11) Patients , who have been previously treated with diuretics 12) Patients with a history of hypersensitivity to ingredients of losartan potassium or hydrochlorothiazide13) Patients with a history of hypersensitivity to thiazide or thiazide-like diuretics13) Patients with a history of hypersensitivity to ingredients of a calcium channel blocker to be used in the study14) Patients who are considered not eligible for the study by the attending doctor due to medical reasons

Design outcomes

Primary

MeasureTime frame
Change in blood pressure level measured on an outpatient basis after 12 weeks of treatment

Secondary

MeasureTime frame
- Change in blood pressure level measured on an outpatient basis after 24,48 weeks of treatment- Changes in blood pressure level at home after getting up,ABPM,NT-proBNP,hs-CRP,PAI-1,Aldosterone after 12, 24 and 48 weeks of treatment- Change in catroid internal-medical thickness after 48 weeks of treatment

Countries

Japan

Contacts

Public ContactRyuji Toh

Kobe University Graduate School of Medicine Division of Cardiovascular Medicine

rtoh@med.kobe-u.ac.jp078-382-5846

Outcome results

None listed

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