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CompletedNCT00969072Updated Sep 13, 2010

Extension Study of GI198745 to Treat Benign Prostatic Hyperplasia

A Phase 2 interventional study of GI198745 0.05mg and GI198745 0.5mg in Benign Prostatic Hyperplasia and Prostatic Hyperplasia, sponsored by GlaxoSmithKline. Completed. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2010-09-13.

Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
121
Allocation
Randomized
Ages
50 Years and older
Sex
Male
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Benign Prostatic Hyperplasia
  • Prostatic Hyperplasia

Keywords

  • GI198745
  • Long term extension study
  • BPH
03

In context

Prostatic Hyperplasia

783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.

This study's enrollment of 121 is above the median of 97 across 593 interventional studies indexed under Prostatic Hyperplasia.

Browse Prostatic Hyperplasia studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

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

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  • Is withdrawn from the dose finding study.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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
121 participants (actual)

Study arms

  • Experimental
    GI198745

    Drug: GI198745 0.05mg · Drug: GI198745 0.5mg · Drug: GI198745 2.5mg

Interventions

  • DrugGI198745 0.05mg

    GI198745 (drug) - benign prostatic hyperplasia

  • DrugGI198745 0.5mg

    GI198745 (drug) - benign prostatic hyperplasia

  • DrugGI198745 2.5mg

    GI198745 (drug) - benign prostatic hyperplasia

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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 outcomes

  1. prostate volume, symptom scores (IPSS), maximum urinary flow (Qmax), serum dihydrotestosterone (DHT), and testosterone

    Time frame: 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)

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 13, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00969072
Lead sponsor
GlaxoSmithKline
First posted
Aug 31, 2009
Start date
Aug 2003
Primary completion
Feb 2005
Completion
Feb 2005
Last update
Sep 13, 2010

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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