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Double-blind randomized study to compare the efficacy and safety of tamsulosin prolonged release tablet 0.4 mg with Harnal capsule 0.2 mg in patients with lower urinary tract symptoms (LUTS) associated with benign prostate hyperplasia (BPH)

Double-blind randomized study to compare the efficacy and safety of tamsulosin prolonged release tablet 0.4 mg with Harnal capsule 0.2 mg in patients with lower urinary tract symptoms (LUTS) associated with benign prostate hyperplasia (BPH)

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1080221287
Enrollment
400
Registered
2010-10-29
Start date
2010-10-29
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

Lower urinary tract symptoms, Benign prostate hyperplasia

Interventions

investigational material(s) Generic name etc : tamsulosin prolonged release tablets INN of investigational material : Therapeutic category code : 259 Other agents for uro-genital and anal organ Dosag

Sponsors

Astellas Pharma Inc.
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: A total I-PSS of 8 to 30 A maximum flow rate in range of 5-15 ml/s; Voided volume of 150 ml or over Residual volume of 100ml or less Prostate volume of 20ml or over

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Change in total I-PSS—

Secondary

MeasureTime frame
Change in individual I-PSS—

Outcome results

None listed

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