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Clinical trial

A Randomized, Double-blind, Controlled, Non-inferiority Multicenter Phase III Clinical Study Evaluating the Efficacy and Safety of H077 Sustained-release Tablets Versus Silodosin Capsules in the Treatment of Benign Prostatic Hyperplasia

NCT07146386 is registered in ClinicalTrials.gov with Shanghai Huilun Pharmaceutical Co., Ltd. as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
A Randomized, Double-blind, Controlled, Non-inferiority Multicenter Phase III Clinical Study Evaluating the Efficacy and Safety of H077 Sustained-release Tablets Versus Silodosin Capsules in the Treatment of Benign Prostatic Hyperplasia
Lead sponsor
Shanghai Huilun Pharmaceutical Co., Ltd.
Phase
Phase 3
Overall status
Not yet recruiting
Start date
August 31, 2025
Completion date
March 31, 2027
Enrollment
728 (estimated)
Sites
66

Conditions

As the registry lists them; a condition with its own page is linked.

benign prostatic hyperplasia, benign prostatic hyperplasia with lower urinary tract symptoms