Dutasteride (GI198745) In Benign Prostatic Hyperplasia Subjects
NCT00368979 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 378
Last updated 2018-09-26
Summary
This study will assess the efficacy and safety of GI198745 0.5mg given once daily for 52 weeks to Benign Prostatic Hyperplasia (BPH) patients.
Conditions
- Prostatic Hyperplasia
Interventions
- DRUG
-
Dutasteride
once daily
- DRUG
-
once daily
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
GSK Clinical Trials · GlaxoSmithKline
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-02-17
- Primary Completion
- 2007-12-01
- Completion
- 2007-12-06
Countries
- Japan
Study Locations
More Related Trials
-
Effect of Dutasteride on Bladder Wall Hypertrophy in Patients With Benign Prostatic Obstruction
NCT00827814 ·Status: COMPLETED ·Phase: PHASE4
-
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 Hyperplasia
NCT02058368 ·Status: COMPLETED ·Phase: PHASE3
-
Dutasteride for Improving Peri-Operative and Long-Term Outcomes of Photoselective Vaporization of the Prostate (DOP)
NCT00274417 ·Status: UNKNOWN ·Phase: NA
-
Prospective Sexual Function Study for BPH Subjects
NCT01777269 ·Status: COMPLETED ·Phase: PHASE4
-
Benign Prostatic Hyperplasia Trial With Dutasteride And Tamsulosin Combination Treatment
NCT00090103 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of an Investigational Study Drug for Benign Prostatic Hyperplasia (0906-140)
NCT00127179 ·Status: COMPLETED ·Phase: PHASE3
-
Role of Dutasteride in Treatment of Chronic Prostatitis
NCT04756206 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Role of Dutasteride in Patients Undergoing 3D Mapping Biopsy in Early Stage Prostate Cancer
NCT00985738 ·Status: TERMINATED ·Phase: PHASE2
-
Safety and Efficacy of 0.5mg Dutasteride and 0.4mg Tamsulosin Combination Once Daily for Six Months for Benign Prostatic Hyperplasia
NCT01673490 ·Status: TERMINATED ·Phase: PHASE4
-
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.
NCT01254071 ·Status: COMPLETED ·Phase: PHASE1
-
Α Prospective Observational Study for the Evaluation of Disease Control and Quality of Life in Patients With Benign PROStatic hyPERplasia Under Fixed Dose combΙnaTion Treatment With Dutasteride and Tamsulosin . PROSPERITY Group of Studies (I&II)
NCT04831476 ·Status: COMPLETED
-
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 Samples
NCT01957189 ·Status: COMPLETED ·Phase: PHASE1
-
Long-term Effects of Dutasteride on Architectural and Nuclear Morphometric Features of Benign Prostate Tissue
NCT01473030 ·Status: COMPLETED
-
Dutasteride With Tolterodine ER or Placebo to Treat Lower Urinary Tract Symptoms (LUTS)
NCT00939120 ·Status: COMPLETED ·Phase: PHASE4
-
Bioequivalence Study of the Second Generation Dutasteride and Tamsulosin HCl Combination Capsule in Fed State
NCT02058576 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Determine the Improvement of the Symptoms of Benign Prostatic Hyperplasia (BPH) When Switching Subjects From Proscar to Avodart
NCT00690950 ·Status: UNKNOWN ·Phase: PHASE4
-
A Study To Compare 3 Different Formulations Of Tamsulosin At Steady State.
NCT00609596 ·Status: COMPLETED ·Phase: PHASE1
-
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 States
NCT02184585 ·Status: COMPLETED ·Phase: PHASE1
-
An Observational Study of Dutasteride and Alpha-blocker Combination Therapy in Men With Symptomatic Benign Prostatic Hyperplasia and PSA Level Over 4 ng/mL
NCT01351987 ·Status: UNKNOWN
-
Efficacy and Toxicity of Bicalutamide and Dutasteride vs. Standard Care for Prostate Cytoreduction for Brachytherapy
NCT00866554 ·Status: COMPLETED ·Phase: PHASE2
-
Drug Use Investigation for AVOLVE(BPH)
NCT01376284 ·Status: COMPLETED
-
Effects Of Dutasteride On Risk Reduction Of Acute Urinary Retention Relapse Following Trial Without Catheter
NCT00421421 ·Status: TERMINATED ·Phase: PHASE4
-
Bioequivalence Study of the Second Generation Dutasteride and Tamsulosin Hydrochloride (HCL) Combination Capsule in Fasted State
NCT02052713 ·Status: COMPLETED ·Phase: PHASE1
-
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 Enlargement
NCT01294592 ·Status: COMPLETED ·Phase: PHASE4
-
Effects and Safety of OPK-88004 Doses in Men With Signs and Symptoms of Benign Prostatic Hyperplasia (BPH)
NCT03297398 ·Status: TERMINATED ·Phase: PHASE2