GlaxoSmithKline: Prostatic Hyperplasia trials

The registry lists 43 Prostatic Hyperplasia studies with GlaxoSmithKline as lead sponsor. 0 are open to participants now and 17 have results posted.

Phase 1 13Phase 2 1Phase 3 5Phase 4 7No phase 17(a study in two phases counts in both)

Studies

Open to participants first, then studies with results posted, then the rest; newest registration first within each.

• Benign Prostatic Hyperplasia (BPH) Screening Tool Case Finding Study in Subjects >=50 YearsCompletedNCT02757963Phase 4Results posted
• Study to Compare the Efficacy and Safety of Combination Treatment With Dutasteride and Tamsulosin With Tamsulosin Monotherapy, in Men With Moderate to Severe Benign Prostatic HyperplasiaCompletedNCT02058368Phase 3Results posted
• Prospective Sexual Function Study for BPH SubjectsCompletedNCT01777269Phase 4Results posted
• Safety and Efficacy of 0.5mg Dutasteride and 0.4mg Tamsulosin Combination Once Daily for Six Months for Benign Prostatic HyperplasiaTerminatedNCT01673490Phase 4Results posted
• Establishing Predictors of Enlarged Prostate Treatment Adherence: Linking Symptom Improvement to AdherenceCompletedNCT01390870Results posted
• Clinical and Economic Outcomes of Patients Utilizing Combination Therapy for Enlarged Prostates: A Henry Ford Database AssessmentCompletedNCT01386983Results posted
• Demonstrating the Clinical and Economic Benefit of 5 Alpha Reductase Inhibitor Adherence in Benign Prostatic HyperplasiaCompletedNCT01334723Results posted
• Evaluating the Impact of Early Versus Delayed 5 Alpha Reductase Inhibitor Treatment on the Risk of Emergent Surgery in Men With Benign Prostatic HyperplasiaCompletedNCT01332487Results posted
• Dutasteride in Enlarged Prostate Economic Assessment: A Retrospective Database Pooled Analysis of Early 5-alpha Reductase Inhibitor UseCompletedNCT01332435Results posted
• SECOTEX® (Tamsulosin Hydrochloride) Bioequivalence Study Brazil - Fed AdminCompletedNCT01330303Phase 1Results posted
• Benign Prostatic Hypertrophy Treatment Patterns & Outcomes: MarketscanCompletedNCT01323998Results posted
• AVODART(Dutasteride) Post-marketing Surveillance(PMS)CompletedNCT01299571Results posted
• Comparative Efficacy of Dutasteride Plus Tamulosin With Lifestyle Advice Versus Watchful Waiting Plus Lifestyle Advice in the Management of Treatment naïve Men With Moderately Symptomatic Benign Prostatic Hyperplasia and Prostate EnlargementCompletedNCT01294592Phase 4Results posted
• SECOTEX® (Tamsulosin Hydrochloride) Bioequivalence Study Brazil - Fast AdminCompletedNCT01262989Phase 1Results posted
• Dutasteride 0.5mg For The Treatment Of Chinese Patients With Benign Prostatic Hyperplasia (BPH)CompletedNCT00527605Phase 3Results posted
• Dutasteride (GI198745) In Benign Prostatic Hyperplasia SubjectsCompletedNCT00368979Phase 3Results posted
• Benign Prostatic Hyperplasia Trial With Dutasteride And Tamsulosin Combination TreatmentCompletedNCT00090103Phase 3Results posted
• Bioequivalence Study of Dutasteride Capsules in Healthy Japanese Male SubjectsCompletedNCT02578953Phase 1
• Bioavailability Study of Fixed Dose Combination (FDC) Dutasteride and Tamsulosin Hydrochloride (HCl) Relative to One Dutasteride and One Tamsulosin HCl Tablet in Healthy Male SubjectsCompletedNCT02509104Phase 1
• Comparative Bioavailability of Two Fixed Dose Combination (FDC) Formulations of Dutasteride and Tamsulosin Hydrochloride Relative to Co-administration of Dutasteride With Tamsulosin Hydrochloride in Healthy Male Subjects Under Fed and Fasted StatesCompletedNCT02184585Phase 1
• This Will be an Open-label, Three-period, Fixed-sequence Study to Evaluate the Drug-drug Interaction, Pharmacokinetics and Safety of Dutasteride and Tamsulosin When Administered Alone and In-combination in Chinese Healthy Male Volunteers. The Study Will Last Approximately Eleven Weeks. Blood SamplesCompletedNCT01957189Phase 1
• WEUSKOP5723: Prostate Cancer StudyCompletedNCT01767363
• Bioequivalence - Duodart Against Avodart & OmnicCompletedNCT01657851Phase 1
• Study to Compare the Bioavailability of Dutasteride Novel Formulation Form to the Soft Gel Capsule Form in Healthy Male SubjectsCompletedNCT01577693Phase 1
• A Study Assessing a Range of Formulations of the Fixed Dose Combination Product Containing Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) to Find a Formulation Which is Bioequivalent to Harnal-D Tablets (Tamsulosin Hydrochloride, 0.2mg) in Healthy Male Subjects From North East AsiaCompletedNCT01495026Phase 1
• Bioavailability of Two Combination Products of Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) in Asian Males.CompletedNCT01471678Phase 1
• Clinical Progression and Costs in Benign Prostatic Hyperplasia Patients Treated With Early Versus Delayed Combination TherapyCompletedNCT01435954
• Establishing the Benefits of Adherence to Enlarged Prostate Treatment: A Validation Study Linking Adherence to Outcomes Using the Market Scan DatabaseCompletedNCT01381510
• Drug Use Investigation for AVOLVE(BPH)CompletedNCT01376284
• Benefits of Adherence to 5-alpha Reductase Inhibitor Treatment in Men With Enlarged Prostate: An Assessment of Medicare and Medicaid Patients Using the MarketScan DatabaseCompletedNCT01376258
• Korean Practice Patterns for Screening PCA(Prostate Cancer)CompletedNCT01371513
• Economic Analyses of the REDUCE TrialCompletedNCT01337258
• A Study to Determine the Bioavailability of a Fixed Dose Combination Product of Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) Relative to Co-administration of the Individual Components in Healthy Male Subjects of North East Asian and Non-Asian Ancestry.CompletedNCT01254071Phase 1
• Extension Study of GI198745 to Treat Benign Prostatic HyperplasiaCompletedNCT00969072Phase 2
• ARI103094-Follow-Up Study for REDUCE Study SubjectsCompletedNCT00883909
• A Study To Compare 3 Different Formulations Of Tamsulosin At Steady State.CompletedNCT00609596Phase 1
• Pharmacovigilance Study To Evaluate Safety Of AVODART In Subjects With Benign Prostate HyperplasiaCompletedNCT00593593
• A Study To Compare Giving AVODART And FLOMAX Together Or In A Combination Capsule In The Fed And Fasted StateCompletedNCT00537654Phase 1
• Effects Of Dutasteride On Risk Reduction Of Acute Urinary Retention Relapse Following Trial Without CatheterTerminatedNCT00421421Phase 4
• Effects On Dihydrotestosterone Regulated Gene Expression In Benign Prostatic Hyperplasia Or Prostate CancerCompletedNCT00375765Phase 4
• Observational AVODART (Dutasteride) Study In Benign Prostatic Hyperplasia Subjects - OASISCompletedNCT00316732
• Levofloxacin For The Management Of Patients With Abnormal Prostate Specific Antigen (PSA)CompletedNCT00169585Phase 3
• Effect Of Dutasteride On Intraprostatic Dihydrotestosterone (DHT) LevelsCompletedNCT00062790Phase 4