Phase 3 Study of Tadalafil Once-Daily in Asian Men With Benign Prostatic Hyperplasia (BPH)

Phase 3 Completed 610 enrolled Eli Lilly and Company

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a phase 3, randomized, double-blind, placebo-controlled, parallel-design, multinational study to evaluate the efficacy and safety of tadalafil once-a-day dosing for 12 weeks in Asian men with signs and symptoms of benign prostatic hyperplasia.

Timeline

Start: 2011-12
Primary completion: 2012-10
Completion: 2012-10

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs Tadalafil; p <0.001; Mean Difference (Final Values) -1.5 (95% CI -2.4 to -0.6); Mixed Models Analysis NCT01460342 ↗

Publications

Takeda M, Yokoyama O, Lee SW, Murakami M, Morisaki Y, Viktrup L. Tadalafil 5 mg once-daily therapy for men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: results from a randomized, double-blind, placebo-controlled trial carried out in Japan and Korea. Int J Urol. 2014 Jul;21(7):670-5. doi: 10.1111/iju.12410. Epub 2014 Feb 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tadalafil	Small molecule	5 mg	Oral