Multinational Study to Evaluate Tadalafil in Asian Men With Signs and Symptoms of Benign Prostatic Hyperplasia

Lilly

Status and phase: Completed; Phase 3

Conditions: Benign Prostatic Hyperplasia

Treatments: Drug: Tadalafil; Drug: Placebo; Drug: Tamsulosin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00861757

10487

H6D-MC-LVHB (Other Identifier)

Details and patient eligibility

About

This study is a randomized, double-blind, placebo and tamsulosin-controlled, parallel design, multinational study to evaluate the efficacy and safety of Tadalafil once-a-day dosing for 12 weeks in Asian men with signs and symptoms of benign prostatic hyperplasia (BPH).

Enrollment: 612 patients

Sex: Male

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Asian males, with benign prostatic hyperplasia (BPH) for at least 6 months prior to initiation and IPSS score greater than or equal to 13 at the beginning of the treatment
• Agree not to use any other approved or experimental pharmacologic BPH, erectile dysfunction (ED) and overactive bladder (OAB) treatments at any time during the study.
• Have not taken Finasteride or Dutasteride therapy, Anti-androgenic hormone or any other BPH therapy, ED or OAB therapy for specified duration of time prior to the beginning of the treatment

Exclusion criteria

• Prostate specific antigen (PSA) score beyond acceptable range defined for study at initiation
• History of urinary retention or lower urinary tract (bladder) stones within 6 months of initiation
• History of urinary urethral obstruction due to stricture, valves, sclerosis, or tumor at initiation
• Clinical evidence of prostate cancer at initiation
• Clinical evidence of any of the bladder or urinary tract conditions, which may affect lower urinary tract symptom at initiation
• History of cardiac conditions, including Angina requiring certain treatment with nitrates, unstable angina defined for study, positive cardiac stress test before starting the study
• History of significant central nervous system injuries (including stroke or spinal cord injury within 6 months of initiation)
• Use of any nitrates, cancer chemotherapy, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone (LHRH)agonists/antagonists, or anabolic steroids at initiation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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612 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

2.5 mg Tadalafil

Experimental group

Treatment:

Drug: Tadalafil

5.0 mg Tadalafil

Experimental group

Treatment:

Drug: Tadalafil

0.2 mg Tamsulosin

Active Comparator group

Treatment:

Drug: Tamsulosin