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Extension Study of GI198745 to Treat Benign Prostatic Hyperplasia

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00969072
First received: July 23, 2009
Last updated: September 9, 2010
Last verified: September 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Benign Prostatic Hyperplasia
Prostatic Hyperplasia
 Drug: GI198745 0.05mg
Drug: GI198745 0.5mg
Drug: GI198745 2.5mg
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Long-term Extension Study of GI198745 in Subjects With Benign Prostatic Hyperplasia

Resource links provided by NLM:

Drug Information available for: Dutasteride
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 121
Study Start Date: August 2003
Study Completion Date: February 2005
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GI198745 Drug: GI198745 0.05mg
GI198745 (drug) - benign prostatic hyperplasia
Drug: GI198745 0.5mg
GI198745 (drug) - benign prostatic hyperplasia
Drug: GI198745 2.5mg
GI198745 (drug) - benign prostatic hyperplasia

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00969072

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00969072     History of Changes
Other Study ID Numbers: ARI30016
Study First Received: July 23, 2009
Last Updated: September 9, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceutical and Medical Device Agency

Keywords provided by GlaxoSmithKline:
GI198745
Long term extension study
BPH

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
 Dutasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013