Extension Study of GI198745 to Treat Benign Prostatic Hyperplasia
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Benign Prostatic Hyperplasia; Prostatic Hyperplasia
Intervention: GI198745 0.05mg (Drug); GI198745 0.5mg (Drug); GI198745 2.5mg (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Summary
The primary objective is to assess the safety of GI198745 0. 05mg, 0. 5mg, 2. 5mg once daily
for 52 weeks.
Clinical Details
Official title: A Long-term Extension Study of GI198745 in Subjects With Benign Prostatic Hyperplasia
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: 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.
Secondary outcome: prostate volume, symptom scores (IPSS), maximum urinary flow (Qmax), serum dihydrotestosterone (DHT), and testosterone
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.
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Male.
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- Is withdrawn from the dose finding study.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.
Locations and Contacts
Additional Information
Starting date: August 2003
Last updated: September 9, 2010
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