Effect of on combination therapy with irbesartan and amlodipine besilate on clinical blood pressure, home blood pressure and blood pressure variability in hypertensive patients with chronic kidney disease

Effect of on combination therapy with irbesartan and amlodipine besilate on clinical blood pressure, home blood pressure and blood pressure variability in hypertensive patients with chronic kidney disease - Effect of combination therapy with irbesartan and amlodipine besilate on hypertensive patients with chronic kidney disease

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013213

Enrollment

Registered

2014-02-21

Start date

2013-08-01

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 with chronic kidney disease (CKD G1-G4)

Interventions

Irbesartan / amlodipine besilate combination tablets

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) CKD G1-G4. 2) Under the antihypertensive therapy (standard doses of RAS inhibitor or Calcium channel blocker). 3) Blood pressure at hospital visit: Systolic blood pressure is 130 mmHg or higher, or diastolic blood pressure is 80 mmHg or higher.

Exclusion criteria

Exclusion criteria: 1) CKD G5 or dialysis patients. 2) Patients who have allergy for amlodipine besilate or irbesartan. 3) Patients who are pregnant. 4) Patients judged as inappropriate for the study.

Design outcomes

Primary

Measure	Time frame
Efficacy: Change in the following from baseline to Week 4,8,12: -Clinical blood pressure, within visit blood pressure variability -Home blood pressure, home blood pressure variability -Nighttime blood pressure, nighttime blood pressure variability Efficacy: Change in the following from baseline to Week 12: -Body weight, obesity, abdominal circumference -Laboratory parameters (renal function, oxidative stress etc.) -Vascular function (AI, ABI/PWV, CAVI)	—

Measure

Time frame

Efficacy: Change in the following from baseline to Week 4,8,12: -Clinical blood pressure, within visit blood pressure variability -Home blood pressure, home blood pressure variability -Nighttime blood pressure, nighttime blood pressure variability Efficacy: Change in the following from baseline to Week 12: -Body weight, obesity, abdominal circumference -Laboratory parameters (renal function, oxidative stress etc.) -Vascular function (AI, ABI/PWV, CAVI)

—

Countries

Japan

Contacts

Public ContactKouichi Tamura

Yokohama City University School of Medicine Department of Cadiorenal Medicine

tamukou@med.yokohama-cu.ac.jp045-787-2635

Outcome results

None listed

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