Extension Study of GI198745 to Treat Benign Prostatic Hyperplasia

Study Overview
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Brief Summary
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The primary objective is to assess the safety of GI198745 0.05mg, 0.5mg, 2.5mg once daily for 52 weeks.

Detailed Description
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Upon completion of 24 weeks of GI198745 0.05 mg, 0.5 mg, 2.5 mg, or placebo therapy in study ARI20005, subjects are enrolled into an extension phase and are continued on the same therapy once daily for up to further 28 weeks, followed by up to 16 weeks of post-dosing assessments.

Official Title
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A Long-term Extension Study of GI198745 in Subjects With Benign Prostatic Hyperplasia

Conditions
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Benign Prostatic Hyperplasia, Prostatic Hyperplasia

Intervention / Treatment
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* Drug: GI198745 0.05mg
* Drug: GI198745 0.5mg
* Drug: GI198745 2.5mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has been receiving the investigational product for at least 20 weeks in the preceding dose finding study and the investigator or subinvestigator has confirmed the tolerability and has judged as appropriate to participate continuously in further 28 weeks treatment. Exclusion Criteria: Is withdrawn from the dose finding study. Has less than 75% compliance with the investigational product in the dose finding study at given the informed consent for the long-term extension study. Has a prostate cancer at giving informed consent for participating in the long-term extension study; or is suspected to have a prostate cancer in palpation, ultrasound imaging, biopsy, etc. at giving informed consent for participating in the long-term extension study. Has the post void residual volume > 250 ml at starting the long-term extension study. (as measured by suprapubic ultrasound). Has chronic bacterial prostatitis or chronic urinary tract infections during the dose finding study Has acute urinary retention in the dose finding study. Has a history or current evidence of drug or alcohol abuse during the dose finding study Has been treated with any investigational product including post-marketing clinical trials during the dose finding study. Has myocardial infarction, coronary arterial bypass surgery, unstable angina, arrhythmia, congestive heart failure, cerebrovascular accident during the dose finding study. Has any concurrent disease or complication that, in the opinion of the investigator/sub-investigator, is difficult to evaluate efficacy of GI198745 in this study and that might poses additional risk to the patient. Is actively trying to procreate in the study period. Is unsuitable for this study, in the opinion of the investigator/sub-investigator.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GI198745<br> | Drug: GI198745 0.05mg<br>* GI198745 (drug) - benign prostatic hyperplasia<br>Drug: GI198745 0.5mg<br>* GI198745 (drug) - benign prostatic hyperplasia<br>Drug: GI198745 2.5mg<br>* GI198745 (drug) - benign prostatic hyperplasia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events, laboratory test values (hematology, serum chemistry, electrolyte, and urinalysis), prostate specific antigen (PSA), vital signs (blood pressure, pulse rate), and post-void residual volume. |  | a 28-week extension treatment in the subjects entered into the 24-week dose finding study (ARI20005: multicentre, double-blind, randomised, placebo-controlled, parallel-group) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prostate volume, symptom scores (IPSS), maximum urinary flow (Qmax), serum dihydrotestosterone (DHT), and testosterone |  | a 28-week extension treatment in the subjects entered into the 24-week dose finding study (ARI20005: multicentre, double-blind, randomised, placebo-controlled, parallel-group) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GI198745, Long term extension study, BPH