A randomized competitive trial of Angiotensin II Receptor Blocker (ARB) for prevention of tumor recurrence in non-muscle invasive bladder cancer

A randomized competitive trial of Angiotensin II Receptor Blocker (ARB) for prevention of tumor recurrence in non-muscle invasive bladder cancer - ARB therapy for non-muscle invasive bladder cancer

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005044

Enrollment

200

Registered

2011-04-01

Start date

2011-04-01

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

Bladder cancer

Interventions

ARB therapy for non-muscle invasive bladder cancer Calcium channel blocker therapy for non-muscle invasive bladder cancer

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Pathological diagnosis ; urothelial carcinoma. 2. Patients who are initially diagnosed as non-muscle invasive bladder cancer and treated completely by transurethral resection. 3. More than 20 years old at diagnosis. 4. Performance status (ECOG) of the cases should be 0 or 1. 5. Function of important organ should be sufficient. 6. Tolerable for internal use for ARB. 7. Agreement form for this study should be obtained from the patients. 8. Inspection value standard 3000/mm3 <= WBC < 12,000/mm3 Neutrophile ;1,500/mm3<= Platelet ;100,000/mm3<= sGOT/sGPT ; Within twice of normal range in respective institutes. sT-bilirubin; <3mg/dl Hb; =>9.0g/dls Creatinin; <2.0mg/dl

Exclusion criteria

Exclusion criteria: 1. Prior therapy of ARB and/or ACE inhibitor. 2. Normal blood pressure 3. Patients with primary CIS. 4. Presence of active other cancers. Having a severe complications occurred before this study; serious heart failure, renal failure, liver dysfunction, severe infection, and blood trouble. 5. Contraindications for ARB or Calcium channel blocker. (According to attached files of ARB or Calcium channel blocker.) 6. A pregnant women, a woman of breast-feeding, a woman who want to get pregnant. Presence of severe allergy for medicines.

Design outcomes

Primary

Measure	Time frame
3-year recurrence-free survival rate	—

Secondary

Measure	Time frame
Safety Quality of Life Overall survival	—

Countries

Japan

Contacts

Public ContactNobuyuki Tanaka

Keio University School of Medicine Department of Urology

urotanaka@a2.keio.jp03-3353-1211

Outcome results

None listed

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