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Study ID Status Title Patient Level Data
ARI10016 Completed A Double-Blind, Randomized, Placebo-Controlled Study to Determine the Effect of GI198645 (dutasteride) Dose for 21 Days on the Pharmacokinetics and Pharmacodynamics of Warfarin in Healthy Male Volunteers.
ARI10017 Completed A study to investigate the effect of GI198745 (dutasteride) on the pharmacokinetics of digoxin in healthy male volunteers.
ARI10018 Completed An Evaluation of the Bioequivalence of GI198745/dutasteride Soft Gelatin Capsules Compared to GI198745/dutasteride Cross-linked Gelatin Capsules in Healthy Male Volunteers.
ARI10019 Completed A double-blind, placebo-controlled, randomized, parallel group study to investigate the changes in corrected QT interval following repeat oral doses of GI198745 in healthy male subjects Study Listed on ClinicalStudyDataRequest.com
ARI10023 Completed A double blind, randomized and placebo-controlled parallel group study to evaluate the safety and pharmacokinetics/pharmacodynamics of a single oral 0.5mg dose of dutasteride in healthy Korean male volunteers.
ARI105326 Completed Clinical Evaluation of dutasteride in Benign Prostatic Hyperplasia: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparative Study of GI198745 (dutasteride) in Subjects with Benign Prostatic Hyperplasia.
ARI108898 Completed A randomized, double-blind, placebo-controlled, six-month parallel-group study to assess efficacy and safety of dutasteride 0.5mg once daily in Chinese patients with Benign Prostatic Hyperplasia (BPH), followed by a 12-month open-label treatment phase
ARI109882 Completed An Open-Label, Randomized, Single Dose Three-Period Partial Crossover Study to Determine the Bioequivalence and Food Effect of a Combination Capsule Formulation of Dutasteride and Tamsulosin Hydrochloride (0.5mg/0.4mg) Compared to Concomitant Dosing of AVODART™ 0.5mg and Flomax 0.4mg Commercial Capsules in Healthy Male Subjects Study Listed on ClinicalStudyDataRequest.com
ARI109924 Completed A Randomised, Double-Blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Dutasteride (AVODART™) 0.5 mg in Extending the Time to PSA Doubling in Men with Prostate Cancer and Biochemical Failure (PSA increase) after Radical Therapy with Curative Intent
ARI111402 Completed An open label, randomized, repeat dose, 3 period crossover study to determine the bioequivalence of 3 different formulations of tamsulosin at steady state in healthy male volunteers Study Listed on ClinicalStudyDataRequest.com
ARI19033 Completed An open label, single dose, randomised, three period crossover study to investigate the relative bioavailability of dutasteride softgel vs. dutasteride tablet and dutasteride softgel vs. dutasteride capsule in healthy male volunteers Study Listed on ClinicalStudyDataRequest.com
ARI20005 Completed A multi-centre, double-blind, stratified randomized, placebo-controlled, parallel group comparative, dose finding study of GI198745 in patients with benign prostatic hyperplasia
ARI30015 Completed Multicentre, randomized, placebo-controlled, double-blind, parallel-group, phase IIIB clinical trial evaluating the efficacy of dutasteride in the prevention of bleeding related to prostate transurethral resection in subjects presenting with BPH.
ARI30016 Completed A long-term extension study of GI198745 in patients with Benign Prostatic Hyperplasia
ARI40001 Completed A multicentre, randomised, double-blind, double-dummy, parallel group study to compare the efficacy of GI198745 0.5mg Once Daily versus finasteride 5mg Once Daily for 12 months in the treatment of subjects with benign prostatic hyperplasia (BPH). (EPICS) Study Listed on ClinicalStudyDataRequest.com
ARI40001_1 Completed A Multicentre, Randomised, Double-Blind, Double-Dummy, Parallel-Group Study to Compare the Efficacy of Dutasteride/GI198745 0.5mg Once Daily Versus Finasteride 5mg Once Daily for 12 Months in the Treatment of Subjects with Benign Prostatic Hyperplasia (BPH), Followed by an Optional 24 Months Open Label Phase. Study Listed on ClinicalStudyDataRequest.com
ARI40002 Completed A pilot multi-centre, double-blind, parallel group, randomised study to investigate the effect on symptoms 3 months after discontinuing tamsulosin, following 6 months combination treatment with 0.5mg GI198745 and 0.4mg tamsulosin daily in patients with symptomatic Benign Prostatic Hyperplasia (BPH). Study Listed on ClinicalStudyDataRequest.com
ARI40005 Completed A randomized, double-blind, parallel group study to investigate the efficacy and safety of treatment with dutasteride (0.5mg) and tamsulosin (0.4mg), administered once daily for 4 years, alone and combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic benign prostatic hyperplasia Study Listed on ClinicalStudyDataRequest.com
ARI40006 Completed A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Dutasteride 0.5 mg Administered Orally Once Daily for Four Years to Reduce the Risk of Biopsy-Detectable Prostate Cancer Study Listed on ClinicalStudyDataRequest.com
ARI40007 Completed A Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study Investigating the Effects of Either 4 or 6 Weeks Dutasteride 0.5mg Daily on Peri-Operative Bleeding Following Transurethral Resection of the Prostate (TURP) in Subjects with Benign Prostatic Hyperplasia (BPH). Study Listed on ClinicalStudyDataRequest.com
ARI40010 Completed Multicenter, double-blind, randomized, parallel-group study, comparing 0.5 mg and 3.5 mg dutasteride daily for 4 months prior to radical prostatectomy versus radical prostatectomy alone in men with biopsy-proven and clinically localized prostate cancer Study Listed on ClinicalStudyDataRequest.com
ARI40013 Completed GI 198745 in the Treatment of Symptomatic Benign Prostatic Hyperplasia (BPH): An Open, Multicentre, Phase IIIb Study.
ARI40014 Completed Effects of Dutasteride on Intraprostatic Dihydrotestosterone (DHT) Levels Study Listed on ClinicalStudyDataRequest.com
ARIA1001 Completed An Investigation of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GI198745 (dutasteride), an Inhibitor of the 5-Alpha Reductase Enzyme, In Healthy Adult Males
ARIA1002 Completed A pilot investigation of the relative bioavailability of oral formulations of GI198745 (dutasteride), an inhibitor of the 5-alpha reductase enzyme, in healthy adult male volunteers

 

 

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