Safety and Efficacy of 0.5mg Dutasteride and 0.4mg Tamsulosin Combination Once Daily for Six Months for Benign Prostatic Hyperplasia

Summary

Open-label, 6 month-treatment with the IP in all subjects. - Sample size: A total of 90 subjects will be enrolled so that among them at least 57 will complete the 6-month treatment period and evaluable for analysis. -Primary objective: To assess the safety of 0.5 mg dutasteride/0.4 mg tamsulosin combination therapy for six month in BPH patients by monitoring category, frequency and severity of adverse events encountered during the treatment period. -Secondary objective: To assess the efficacy of 0.5 mg dutasteride/0.4 mg tamsulosin combination therapy with regard to symptom improvement in BPH patients by monitoring and analyzing of changes in IPSS and Qmax after 6 months of treatment.

Timeline

Start

2012-06-29

Primary completion

2015-03-20

Completion

2015-03-20

Outcome

Outcome not reported

Stopped: “The sole investigative site refused to accept the amended protocol and declined to continue the study. There was no safety signal nor any other reason.”

Drugs

Indications