Last updated: 11/04/2018 04:45:50
Extension study of GI198745 to treat benign prostatic hyperplasiaN/A
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Long-term Extension Study of GI198745 in Subjects with Benign Prostatic Hyperplasia
Trial description: The primary objective is to assess the safety of GI198745 0.05mg, 0.5mg, 2.5mg once daily for 52 weeks.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
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.
Timeframe: 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:
prostate volume, symptom scores (IPSS), maximum urinary flow (Qmax), serum dihydrotestosterone (DHT), and testosterone
Timeframe: 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)
Interventions:
Drug: GI198745 0.05mg
Drug: GI198745 0.5mg
Drug: GI198745 2.5mg
Enrollment:
121
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Benign Prostatic Hyperplasia
Product
dutasteride
Collaborators
Not applicable
Study date(s)
August 2003 to February 2005
Type
Interventional
Phase
2
Participation criteria
Sex
Male
Age
50+ years
Accepts healthy volunteers
No
- 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.
- Is withdrawn from the dose finding study.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.
Inclusion and 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.
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2005-18-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website