Safety and Efficacy of 0.5mg Dutasteride and 0.4mg Tamsulosin Combination Once Daily for Six Months for Benign Prostatic Hyperplasia (FDC114785)
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pivotal, Open-label Trial Assessing the Safety and Efficacy of the 0.5 mg Dutasteride and 0.4 mg Tamsulosin Combination Once Daily for Six Months in Patients With Benign Prostatic Hyperplasia|
- Use the number of participants with adverse events,serious adverse events and treatment-related adverse events as a measure of Safety [ Time Frame: 6 months treatment and 1 month follow up ] [ Designated as safety issue: Yes ]Using the category,frequency and severity of adverse events,serious adverse events and treatment-related adverse events including abnormalities in heamatology,biochemistry,electrolytes,PSA and ECG encountered during the treatment period.
- Use changes in International Prostate symptom score (IPSS) and Qmax (Maximum rate of Urinary Flow (ml/sec) as a measure of Efficacy [ Time Frame: 6 months ] [ Designated as safety issue: No ]expect to see a decrease in IPSS and an increase Qmax compared to baseline visit
|Study Start Date:||June 2012|
|Study Completion Date:||March 2015|
|Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Single arm testing the efficacy/safety of the combinnation of Dutasteride/Tamsulosin
0.5 mg dutasteride/ 0.4 mg tamsulosin once daily for the duration of 180 day -treatment
Please refer to this study by its ClinicalTrials.gov identifier: NCT01673490
|GSK Investigational Site|
|Ho Chi Minh, Vietnam|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|