Prospective, randomized, open-label,clinical trial comparing the effects of amlodipine alone and irbesartan/amlodipine combination on blood pressure, endothelial function and makers for obesity/oxidative stress/chronic kidney diseases

Prospective, randomized, open-label,clinical trial comparing the effects of amlodipine alone and irbesartan/amlodipine combination on blood pressure, endothelial function and makers for obesity/oxidative stress/chronic kidney diseases - Prospective, randomized, open-label,clinical trial comparing the effects of amlodipine alone and irbesartan/amlodipine combination

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011725

Enrollment

Registered

2013-09-15

Start date

2013-09-12

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

amlodipine monotherapy irbesartan/amlodipine combination therapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Hypertensive patients with administration of amlodipine 5mg/day who did not reach the recommendation of Hypertension Guidelines issued by Japanese Association of Hypertension

Exclusion criteria

Exclusion criteria: 1) Allergy against 2) Either level of aspartate aminotransaminase or alanine aminotransferase exceeds three-fold of the normal limits. 3) End stage renal disease 4) Subjects whose doctor in charge do not agree to join the trial

Design outcomes

Primary

Measure	Time frame
Blood pressure (On visit/Home monitoring) Flow-mediated vasodilation in forearm Heparin-releasable EC-SOD levels Eight weeks after administration	—

Secondary

Measure	Time frame
Markers indicating obesity (e.g. adiponectin), inflammation (high sensitive CRP), oxidative stress (8-OHdG/ MDA-LDL), early-staged kidney diseases (microalbuminuria) Eight weeks after administration	—

Countries

Japan

Contacts

Public ContactMakoto Ayaori

National Defense Medical College Department of Internal Medicine

ayaori@ndmc.ac.jp04-2995-1617

Outcome results

None listed

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