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Extension Study of GI198745 to Treat Benign Prostatic Hyperplasia

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ClinicalTrials.gov Identifier: NCT00969072
Recruitment Status : Completed
First Posted : August 31, 2009
Last Update Posted : September 13, 2010
Sponsor:
Information provided by:
GlaxoSmithKline

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

Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Prostatic Hyperplasia Drug: GI198745 0.05mg Drug: GI198745 0.5mg Drug: GI198745 2.5mg Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Long-term Extension Study of GI198745 in Subjects With Benign Prostatic Hyperplasia
Study Start Date : August 2003
Actual Primary Completion Date : February 2005
Actual Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Dutasteride

Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00969072


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

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ClinicalTrials.gov Identifier: NCT00969072     History of Changes
Other Study ID Numbers: ARI30016
First Posted: August 31, 2009    Key Record Dates
Last Update Posted: September 13, 2010
Last Verified: September 2010
Keywords provided by GlaxoSmithKline:
GI198745
Long term extension study
BPH
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Dutasteride
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs