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A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo

W

Watson Pharmaceuticals

Status and phase

Completed
Phase 3

Conditions

Benign Prostatic Hyperplasia

Treatments

Drug: Silodosin
Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00224120
SI04010

Details and patient eligibility

About

A new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is safe and effective. The study lasts approximately 20 weeks.

Full description

This will be a multi-center, double-blind, placebo controlled, parallel, 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia. the following procedures are utilized: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the Internation Prostate Symptom Score, maximum urine flow rate, pharmacokinetics, adverse events, concomitant medications, quality of life, and compliance.

Enrollment

462 patients

Sex

Male

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Males in good general health and at least 50 years of age, with symptoms of moderate to severe BPH.

Exclusion criteria

  • Medical conditions that would confound the efficacy evaluation.
  • Medical conditions in which it would be unsafe to use an alpha-blocker.
  • The use of concomitant drugs that would confound the efficacy evaluation.
  • The use of concomitant drugs that would be unsafe with this alpha-blocker.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

462 participants in 2 patient groups, including a placebo group

Silodosin
Experimental group
Description:
Silodosin 8 mg/Day with food
Treatment:
Drug: Silodosin
Placebo
Placebo Comparator group
Description:
Matching placebo capsule once daily with food
Treatment:
Other: Placebo

Trial contacts and locations

42

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Data sourced from clinicaltrials.gov

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