A Phase 3 interventional study of Naftopidil and Tamsulosin in Hyperplasia, sponsored by Apsen Farmaceutica S.A.. Withdrawn at 1 site in Brazil. Open to male participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Apsen Farmaceutica S.A. · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the effectiveness and safety of Naftopidil and Tamsulosin in the treatment of lower urinary tract symptoms through a comparative study of patients with benign prostatic hyperplasia.
Inclusion Criteria:
Men ≥ 50 years Signs and symptoms of BPH A total IPSS of ≥ 10 Prostate volume of ≥20 mL (estimated by ultrasonography) PVR > 150mL
891 studies on the registry are indexed under Hyperplasia; 103 are open to participants now.
Browse Hyperplasia studies →Apsen Farmaceutica S.A. is the lead sponsor of 12 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
0,25 mg (2 weeks) and 0,50 mg (10 weeks)
Drug: Naftopidil
0,4 mg/day
Drug: Tamsulosin
0,25 mg (2weeks) and 0,50 mg (10 weeks)
0,4 mg/day
Also known as: SECOTEX
International Prostate Symptom Score
Time frame: 2, 4, 8 and 12 weeks
Adverse Effect
Time frame: 2, 4, 8 and 12 weeks
This study is withdrawn, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Apsen Farmaceutica S.A.