Assess Safety & Efficacy of WC3055 in Men With Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia

Warner Chilcott

Status and phase: Completed; Phase 2

Conditions: Benign Prostatic Hyperplasia

Treatments: Drug: WC3055; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01939184

PR-05710

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of various fixed daily doses of WC3055 compared with placebo for the treatment of subjects with LUTS secondary to BPH.

Enrollment: 796 patients

Sex: Male

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• History of LUTS for ≥6 months secondary to BPH
• Total IPSS (International Prostate Symptom Score) ≥ 13 at Screening

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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796 participants in 5 patient groups, including a placebo group

WC3055-01F

Experimental group

Description:

WC3055 12.5 mg tablet once daily for 12 weeks

Treatment:

Drug: WC3055

WC3055-02F

Experimental group

Description:

WC3055 25 mg tablet once daily for 12 weeks

Treatment:

Drug: WC3055

WC3055-03F

Experimental group

Description:

WC3055 50 mg tablet once daily for 12 weeks

Treatment:

Drug: WC3055

WC3055-04F

Experimental group

Description:

WC3055 75 mg tablet once daily for 12 weeks

Treatment:

Drug: WC3055

WC3055-07P

Placebo Comparator group

Description:

Placebo tablet once daily for 12 weeks

Treatment:

Other: Placebo