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Candesartan-Based Treatment for Variability Lowering of Individual Blood Pressure and Heart Rate at Home Study

Candesartan-Based Treatment for Variability Lowering of Individual Blood Pressure and Heart Rate at Home Study - Candesartan-Based Treatment for Variability Lowering of Individual Blood Pressure and Heart Rate (CAVALIER) at Home Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000005262
Enrollment
1000
Registered
2011-05-01
Start date
2011-05-01
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

Candesartan 8 mg/amlodipine 5mg once a day Candesartan 8mg/HCTZ 6.25mg once a day

Sponsors

Department of Internal Medicine Division of Cardio-vascular Medicine, Kurume University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Out patients 2. Patients who can not achieve JSH2009 target levels of casual BP, morning BP, or evening BP even under treatment of antihypertensive drug(s)

Exclusion criteria

Exclusion criteria: 1. Poorly controlled hypertension (DBP greater than 120mmHg) 2. Poorly controlled diabetic patients (HbA1c greater than 9.0%) 3. Gout or serum uric acid greater than 8.0mg/dL 4. Renal insufficiency (serum creatinine greater than 2.0mg/dl) 5. Hyperkalimia (K greater than 5.5 mmol/L) 6. Liver damage (gamma-GTP or ALT greater than 3 x normal upper limit) 7. Endocrine secondary hypertension 8. Malignant hypertension 9. Contraindication for candesartan, amlodipine, orHCTZ 10. Prescribed ARB/CCB tablet or ARB/HCTZ tablet before registration

Design outcomes

Primary

MeasureTime frame
Day-to-day variability (standard deviation and coefficiency of variance) of self-measured home systolic BP and heart rate after 6-month treatment

Secondary

MeasureTime frame
1. Visit-to-visit variability of casual BP and heart rate at every clinic visit 2. [morning BP]-[evening BP] 3. Achievement ratios of BP targets (casual BP, morning BP, and evening BP) 4. Changes in circulating levels of hsCRP, hsTnT, NT-proBNP, and collage III N-terminal peptide after 6-month treatment 5. Change in urine microalbumin after 6-month treatment 6. Tolerability and adverse effects

Countries

Japan

Contacts

Public ContactHisashi Kai

Kurume University School of Medicine Department of Internal Medicine Division of Cardio-Vascular Medicine

naikai@med.kurume-u.ac.jp+81-942-31-7562

Outcome results

None listed

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