A Phase 3 interventional study of HCP1303 capsule 5/0.2mg and HCP1303 capsule 5/0.4mg in Benign Prostatic Hyperplasia, sponsored by Hanmi Pharmaceutical Company Limited. Completed. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2016-10-13.
Sponsored by Hanmi Pharmaceutical Company Limited · Phase 3, Interventional, and Treatment
The main objective of this study is to evaluate efficacy and safety of HCP1301 capsule in patients with Benign Prostatic Hyperplasia and Erectile Dysfunction
A multicenter, randomized, double-blind, phase 3 clinical trial to evaluate the efficacy and safety of HCP1303 capsule
783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.
This study's enrollment of 510 is above the median of 97 across 593 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →Hanmi Pharmaceutical Company Limited is the lead sponsor of 188 studies on the registry; 10 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 6 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
At Visit 1
Exclusion Criteria:
HCP1303 capsule 5/0.2mg + HCP1303 capsule 5/0.4mg placebo+ HGP1201 placebo
Drug: HCP1303 capsule 5/0.2mg · Drug: HCP1303 capsule 5/0.4mg placebo · Drug: HGP1201 placebo
HCP1303 capsule 5/0.2mg placebo+ HCP1303 capsule 5/0.4mg + HGP1201 placebo
Drug: HCP1303 capsule 5/0.4mg · Drug: HCP1303 capsule 5/0.2mg placebo · Drug: HGP1201 placebo
HCP1303 capsule 5/0.2mg placebo+ HCP1303 capsule 5/0.4mg placebo+ HGP1201
Drug: HGP1201 · Drug: HCP1303 capsule 5/0.2mg placebo · Drug: HCP1303 capsule 5/0.4mg placebo
Change of Total IPSS (International Prostate Symptom Score)
Time frame: baseline and 12 weeks
Change of Total IPSS
Time frame: baseline and 4weeks, 8sweeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Hanmi Pharmaceutical Company Limited