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comparison of Therapy with Olmesartan medoxomil monotherapy or azelnidipine and olmesartan medoxomil combination in hypertensive patients with chronic KIdney disease

comparison of Therapy with Olmesartan medoxomil monotherapy or azelnidipine and olmesartan medoxomil combination in hypertensive patients with chronic KIdney disease - TOKI Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000004489
Enrollment
80
Registered
2010-11-01
Start date
2010-11-01
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

Hypertensive patients with CKD under the treatment of the angiotensin receptor blocker(ARB), olmesartan medoxomil 20mg/day

Interventions

Olmesartan medoxomil is increased to 40mg/day in patients with the treatment of olmesartan medoxomil(20mg/day).If BP dose not reach to lower than 130/80mmHg, other antihypertensive drug except CCB an

Sponsors

Niigata University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Outpatients to fulfill all the following condition can participate 1) Outpatient systolic BP is equal or more than 130 and less than 180 and/or outpatient diastolic BP is equal or more than 85 and less than 110 mmHg. 2) Outpatients with CKD 3) eGFR is more than 30 mL/min/1.73m2. 4) Age is equal or more than 20 and less than 85 year-old. 5) Olmesartan medoxomil (20mg/day) has been administered for more than 3 months, and the other inhibitor of the renin-angiotensin inhibitor, CCB and diureteic have not been given within 3 months. 6) Written informed consent is obtained based on written and oral explanation of physician in charge.

Exclusion criteria

Exclusion criteria: 1) Secondary hypertension or malignant hypertension (within hypertension in level 3) 2) Severe heart failure (NYHA Class is equal or more than III) 3) Atrial fibrillation or flutter with severe arrhythmia 4) Severe renal failure or liver failure (patient on dialysis, AST or ALT is more than 5 times higher upper limits) 5) Not appropriate for change to the test drugs from current therapy for coronary disease (i.e. CCB, diuretics, etc.) 6) Patient with severe adverse effects by RAS inhibitor, CCB and diuretic 7) Patient has merged the disease seems to be bad, such as malignant tumor prognosis. 8) Type 1 diabetes and type 2 diabetes required hospitalization due to high hemoglobin A1c (equal and more than 9.0%), extremely high blood glucose, or diabetic ketoacidosis. 9) Patients already used other CCB or a diuretic. 10) Pregnant, possible to be pregnant, or willing to be pregnant 11) Patients who are inadequate by determination of physician in charge

Design outcomes

Primary

MeasureTime frame
Changes in urinary albumin/creatinine(Alb/Cr) ratio in early morning samples from pretreatment period to 12 months of treatment

Secondary

MeasureTime frame
1. blood pressure(Office,Home) 2. Pulse rate(Home) 3. Change in the urinary Alb/Cr ratio 4. Change in eGFR 5. Relationship between BMI and BP/urinary Alb/Cr ratio 6. Change in HbA1c levels 7. Change in urinary excretion of sodium 8. Change in serum uric acid 9. Change in urinary megalin and urinary podocalyxin 10. Cerebro-cardio-vascular events

Countries

Japan

Contacts

Public ContactEmiko Kono

Niigata University Graduate School of Medical and Dental Sciences Division of Clinical Nephrology and Rheumatology

e-kouno@med.niigata-u.ac.jp025-227-2200

Outcome results

None listed

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