Extension Study of GI198745 to Treat Benign Prostatic Hyperplasia

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00969072
• Date of registration: 23/07/2009
• Primary sponsor: GlaxoSmithKline
• Public title: Extension Study of GI198745 to Treat Benign Prostatic Hyperplasia
• Scientific title: A Long-term Extension Study of GI198745 in Subjects With Benign Prostatic Hyperplasia
• Date of first enrolment: August 2003
• Target sample size: 121
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00969072
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

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- Is withdrawn from the dose finding study.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.



Age minimum: 50 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Benign Prostatic Hyperplasia

Prostatic Hyperplasia

Intervention(s)

Drug: GI198745 0.05mg

Drug: GI198745 0.5mg

Drug: GI198745 2.5mg

Primary Outcome(s)

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 Outcome(s)

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)]

Secondary ID(s)

ARI30016

Source(s) of Monetary Support

Please refer to primary and secondary sponsors