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NCT05551221: NQTIPS

The Efficacy and Safety of Silodosin Singly or Combined With Ningmitai Capsules in the Treatment of Benign Prostatic Hyperplasia

Recruiting now Phase 4 Last updated 23 September 2022
What this trial tests

Phase 4 trial testing Silodosin Capsules in Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms in 312 participants. Currently enrolling.

Timeline
18 July 2022
Primary endpoint
31 December 2023
31 December 2026

Quick facts

Lead sponsorXintian Pharmaceutical
PhasePhase 4
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment312
Start date18 July 2022
Primary completion31 December 2023
Estimated completion31 December 2026
Sites8 locations across China

Drugs / interventions tested

Conditions studied

Sponsor

Xintian Pharmaceutical — full company profile →

Who can join

Adults 60 to 80, male only, with Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Objective: To evaluate the efficacy and safety of Ningmitai Capsules and Silodosin Capsules in the treatment of Benign Prostatic Hyperplasia (BPH) with Lower Urinary Tract Symptoms (LUTS) compared with Tamsulosin Hydrochloride Sustained Release Capsules. Study design: A multicenter, prospective, randomized, double-blind, positive controlled clinical study. Interventions: Group A: Oral Tamsulosin Hydrochloride Capsules and Ningmitai Capsules placebo for 12 weeks. Group B: Oral l Silodosin Capsules and Ningmitai Capsules placebo for 12 weeks. Group C: Oral l Silodosin Capsules and Ningmitai Capsules for 12 weeks.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms

Currently open trials in the same condition.

Other Xintian Pharmaceutical trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05551221.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing