You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 22, 2024

CLINICAL TRIALS PROFILE FOR DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for dutasteride; tamsulosin hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00090103 ↗ Benign Prostatic Hyperplasia Trial With Dutasteride And Tamsulosin Combination Treatment Completed GlaxoSmithKline Phase 3 2003-11-01 This study will investigate the efficacy and safety of treatment with dutasteride and tamsulosin, administered once daily for 4 years, alone and in combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic Benign Prostatic Hyperplasia (BPH). Study visits are every 3 months for up to 4 years (18 clinic visits). Transrectal ultrasound (TRUS) is done annually.
NCT00244309 ↗ Study of Tamsulosin and/or Dutasteride to Relieve Urinary Symptoms After Brachytherapy for Localized Prostate Cancer Completed GlaxoSmithKline Phase 3 2005-11-01 The purpose of this study is to determine whether a drug named tamsulosin (Flomax), or another drug named dutasteride (Avodart), or a combination of these two drugs is effective in improving urinary symptoms and decreasing the rate of intermittent self-catheterization after prostate brachytherapy.
NCT00244309 ↗ Study of Tamsulosin and/or Dutasteride to Relieve Urinary Symptoms After Brachytherapy for Localized Prostate Cancer Completed Case Comprehensive Cancer Center Phase 3 2005-11-01 The purpose of this study is to determine whether a drug named tamsulosin (Flomax), or another drug named dutasteride (Avodart), or a combination of these two drugs is effective in improving urinary symptoms and decreasing the rate of intermittent self-catheterization after prostate brachytherapy.
NCT00537654 ↗ A Study To Compare Giving AVODART And FLOMAX Together Or In A Combination Capsule In The Fed And Fasted State Completed GlaxoSmithKline Phase 1 2007-10-18 This study will be an open-label, randomized, single dose, three way partial crossover study in healthy male subjects. The aim of the study is to evaluate bioequivalence of a fixed dose combination (FDC) capsule of dutasteride and tamsulosin hydrochloride (HCl) (0.5 milligram [mg]/0.4 mg) relative to co-administration of dutasteride 0.5 mg capsules and tamsulosin hydrochloride 0.4 mg tablets in both the fed and fasted states. Approximately 98 healthy adult male subjects will be enrolled into the study. Subjects will receive single oral doses in 3 treatment periods and be randomized to one of twelve different treatment sequences (ABC, ACB, BAC, BCA, CAB, CBA, ABD, ADB, BAD, BDA, DAB, DBA) wherein A= commercially available tamsulosin hydrochloride 0.4 mg and dutasteride 0.5 mg in a fed state, B= fixed dose combination formulation of dutasteride and tamsulosin hydrochloride (0.5 mg dutasteride, 0.4 mg tamsulosin hydrochloride) in a fed state, C= commercially available tamsulosin hydrochloride 0.4 mg and dutasteride 0.5 mg in a fasted state, D= fixed dose combination formulation of dutasteride and tamsulosin hydrochloride (0.5 mg dutasteride, 0.4 mg tamsulosin hydrochloride) in a fasted state. Each treatment period will be separated by a minimum 28 day washout period. The total duration of a subject's involvement in this study is approximately 15-18 weeks.
NCT00609596 ↗ A Study To Compare 3 Different Formulations Of Tamsulosin At Steady State. Completed GlaxoSmithKline Phase 1 2008-02-26 Dutasteride and tamsulosin are to treat benign prostatic hyperplasia. Studies show that when given together, there is more improvement in symptoms than either drug alone. In this study, we are looking to see if 2 different formulations of tamsulosin in our combination capsules are the same after 7 days of dosing as the US commercial tamsulosin and dutasteride.
NCT00701779 ↗ Dutasteride and Flex Dose of Tamsulosin on as Needed Basis, to Treat Benign Prostatic Hyperplasia Completed GlaxoSmithKline Phase 4 2005-09-01 This study will investigate the efficacy and safety of treatment with Dutasteride (0.5mg), administered once daily for one year in combination with Tamsulosin (0.4mg), administered once daily for 3 months, followed by counseling on flexible dosing of Tamsulosin on an as needed basis, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic benign prostatic hyperplasia (BPH). At each scheduled visit (3, 6, and 9 months), the subject will be counseled on withdrawal of Tamsulosin. After randomization, study visits are every 13 weeks for up to 52 Weeks. (Including Screening, (up to 7 clinic visits)
NCT00701779 ↗ Dutasteride and Flex Dose of Tamsulosin on as Needed Basis, to Treat Benign Prostatic Hyperplasia Completed Siami, Paul F., M.D. Phase 4 2005-09-01 This study will investigate the efficacy and safety of treatment with Dutasteride (0.5mg), administered once daily for one year in combination with Tamsulosin (0.4mg), administered once daily for 3 months, followed by counseling on flexible dosing of Tamsulosin on an as needed basis, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic benign prostatic hyperplasia (BPH). At each scheduled visit (3, 6, and 9 months), the subject will be counseled on withdrawal of Tamsulosin. After randomization, study visits are every 13 weeks for up to 52 Weeks. (Including Screening, (up to 7 clinic visits)
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for dutasteride; tamsulosin hydrochloride

Condition Name

Condition Name for dutasteride; tamsulosin hydrochloride
Intervention Trials
Prostatic Hyperplasia 14
Benign Prostatic Hyperplasia 5
Urologic Diseases 2
Chronic Prostatitis 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for dutasteride; tamsulosin hydrochloride
Intervention Trials
Prostatic Hyperplasia 18
Hyperplasia 18
Urologic Diseases 3
Hypertrophy 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for dutasteride; tamsulosin hydrochloride

Trials by Country

Trials by Country for dutasteride; tamsulosin hydrochloride
Location Trials
United States 42
Germany 31
Italy 20
United Kingdom 12
France 11
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for dutasteride; tamsulosin hydrochloride
Location Trials
Maryland 3
Indiana 3
Texas 2
Ohio 2
New York 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for dutasteride; tamsulosin hydrochloride

Clinical Trial Phase

Clinical Trial Phase for dutasteride; tamsulosin hydrochloride
Clinical Trial Phase Trials
Phase 4 4
Phase 3 5
Phase 1 11
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for dutasteride; tamsulosin hydrochloride
Clinical Trial Phase Trials
Completed 17
Terminated 2
Recruiting 1
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for dutasteride; tamsulosin hydrochloride

Sponsor Name

Sponsor Name for dutasteride; tamsulosin hydrochloride
Sponsor Trials
GlaxoSmithKline 18
Assistance Publique - Hôpitaux de Paris 1
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 1
[disabled in preview] 4
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for dutasteride; tamsulosin hydrochloride
Sponsor Trials
Industry 18
Other 8
NIH 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.