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A multi-site, randomized, double-blind, double-dummy clinical trial to compare the efficacy and the safety of tamsulosin hydrochloride sustained-release tablet 0.4mg and tamsulosin hydrochloride sustained-release capsule 0.2mg to treat dysuria accompanied by benign prostatic hyperplasia

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.

N/A

Astellas Study ID

The unique identification code given by the study sponsor.

617-CL-CN1

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

N/A

Condition

Lower Urinary Tract Symptoms (LUTS), Enlarged Prostate

Phase

These clinical trials are done to confirm that an experimental treatment helps participants who have a specific condition. These clinical trials often compare the experimental treatment to another treatment or, if appropriate, a placebo.

Phase 3

Age

50 Years - N/A

Sex

Male

Product

tamsulosin HCl

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Nov 2009 - Oct 2010

Masking

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Enrollment number

252

A multi-site, randomized, double-blind, double-dummy clinical trial to compare the efficacy and the safety of tamsulosin hydrochloride sustained-release tablet 0.4mg and tamsulosin hydrochloride sustained-release capsule 0.2mg to treat dysuria accompanied by benign prostatic hyperplasia

Study summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

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