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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005686

Enrollment

Registered

2011-06-01

Start date

2010-02-01

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

Administration of aliskiren Administration of amlodipine

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Hypertensive patients with no treatment or administration of antihypertensive drug except below drug, who did not reach the recommendation of Hypertension Guidelines issued by Japanese Association of Hypertension(ARB, ACE, inhibitor of rennin, CCB) 2) Outpatients 3) Subjects who gave written informed consent

Exclusion criteria

Exclusion criteria: 1) Allergy against aliskiren/amlodipine 2) Poor-controlled hypertension (DBP>110 mmHg) 3) Poor-controlled diabetes (HbA1c>8.0 %) 4) Secondary hypertension 5) History of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months 6) Either level of aspartate aminotransaminase or alanine aminotransferase exceeds three-fold of the normal limits. 7) End stage renal disease 8) Symptomatic (NYHA III or IV) congestive heart failure 9) Malignancies or other diseases with poor prognosis 10) Pregnant 11) 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 I

ayaori@ndmc.ac.jp04-2995-1597

Outcome results

None listed

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