Trial · NCT02058368

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, Phase 3, Completed, GlaxoSmithKline; results first posted 2019-04-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 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. Trials, record NCT02058368. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02058368

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: 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
NCT number: NCT02058368
Status: Completed
Phases: Phase 3
Enrollment: 607 participants, actual
Lead sponsor: GlaxoSmithKline
Conditions: Prostatic Hyperplasia
Interventions: Dutasteride 0.5mg capsules, Dutasteride placebo capsules, Tamsulosin 0.2mg tablets, Disintegrating placebo tamsulosin tablet
First posted: 2014-02-10
Last updated: 2019-04-05
Results first posted: 2019-04-05

Source ClinicalTrials.gov

Registered outcomes23

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months	Baseline and 3, 6, 9, 12, 15, 18, 21 and 24 months	IPSS (also called IPSS total score) is the sum of the seven questions with each score ranging from 0 (best) to 5 (worst). IPSS was self administered at screening, Baseline and each time-point of Month 3, 6, 9, 12, 15, 18, 21 and 24. Seven questions included are incomplete emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. The total IPSS score can range from 0-35 with severity catagories of mild (0 to 7), moderate (8 to 19) or severe (20 to 35). LOCF is defined as carrying forward the last non-missing post-Baseline assessment for participants with missing visit data and/or for participants who discontinued from the study. Baseline value is defined as the latest non-missing assessment of either treatment start date or randomization date. Month 24 is the primary timepoint and earlier timepoints are considered secondary. Change from Baseline defined as difference between Post-Baseline value and Baseline value.
Secondary	Percent Change in Prostate Volume From Baseline	Baseline,12 and 24 months	Prostate Volume measurements were conducted annually using Transrectal ultrasound (TRUS). The following calculation was utilized to assess the prostate volume (cc): pi/6 (Anteroposterior Width multiplied by Cephalocaudal Width multiplied by Transverse Width). Post-Baseline prostate volume was calculated at 12 and 24 months. Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline was reported based on the LOCF. Change from Baseline defined as difference between Post-Baseline value and Baseline value and reported as a percentage.
Secondary	Number of Participants With IPSS Improvement From Baseline	Baseline and 3, 6, 9,12,15,18,21 and 24 months	Improvement in IPSS was categorized as improvement, no change and worsening. Improvement defined as greater than or equal to 2 points, greater than or equal to 3 points and greater than or equal to 25 percent in participants at months 3,6,9,12,15,18,21 and 24 . Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline was reported based on the LOCF. Change from Baseline defined as difference between Post-Baseline value and Baseline value.
Secondary	Change From Baseline in Maximum Urine Flow Rate (Qmax) by LOCF Approach	Baseline, 6, 12, 18 and 24 Months	Qmax is defined as maximum urine flow. Qmax was measured with Uroflow meter (Urodyn 1000) at Screening, Baseline, and at Months 6,12,18 and 24. Change from Baseline Qmax at each scheduled post-Baseline assessment was compared in terms of combination treatment (Dut plus Tam) versus tamsulosin treatment using t-tests from a general linear model with effects for treatment, country, and Baseline Qmax. Baseline value was defined as the latest non-missing assessment either treatment start date or randomization date. Change from Baseline defined as difference between Post-Baseline value and Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Secondary	Number of Participants With Qmax Improvement From Baseline by LOCF Approach.	Baseline 6, 12, 18 and 24 Months	Qmax change from Baseline was presented using six improvement levels: \>0 milliliter per second (mL/sec) and \>=1 mL/sec through \>=5mL/sec. Qmax percentage change from Baseline was presented using six improvement levels: \>0%, \>=10%, \>=20%, \>=30%, \>=40%, and \>=50%. Here, Qmax improvement of \>= 3 mL/sec and Qmax percentage of \>= 30 % for 24 Months has been summarized. Baseline value is defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline defined as difference between Post-Baseline value and Baseline value. Baseline value is defined as the latest non-missing assessment of either treatment start date or randomization date.
Secondary	Number of Participants With Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery	Up to 24 Months	AUR is defined as condition when the participant is unable to urinate and requires bladder catheterization. AUR or BPH-related surgery event details per participant was summarized as first occurring of either AUR or BPH-related surgery.
Secondary	Number of Subjects With AUR	Up to 24 Months	AUR is defined as condition when the participant is unable to urinate and requires bladder catheterization.
Secondary	Number of Participants With BPH-related Surgery	Up to 24 Months	BPH-related interventions were recorded. BPH-related interventions included adenomectomy, balloon dilatation, electroresection, thermotherapy (microwave or radiofrequency), laser resection, prostatectomy, prostatotomy, transurethral resection of the prostate, transurethral drainage of prostatic abscess, drainage of prostatic cysts, radioactive seeding of the prostate, prostatic urethral stenting, incision of periurethral stricture, ethanol injections into the prostate, transrectal high intensity focussed ultrasound, transurethral needle ablation and transurethral microwave thermotherapy.
Secondary	Change From Baseline in the BPH-related Health Status (BHS) by LOCF Approach	Baseline, 3, 6, 9, 12, 15, 18, 21 and 24 Months	BHS was collected as Question 8 the IPSS questionnaire regarding quality of life due to urinary symptom with scores values ranging from 0 (delightful) to 6 (terrible). Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from baseline BHS at each scheduled post-baseline assessment was compared in terms of combination treatment (Dut plus Tam) versus tamsulosin treatment using t-tests from a general linear model with effects for treatment, country, and Baseline BHS.
Secondary	Change From Baseline in BPH Impact Index (BII) by LOCF Approach	Baseline 3, 6, 9, 12, 15, 18, 21 and 24 Months	The BII consists of four questions and BII total score is the sum of four questions. Total score range is 0 (no problem) to 13 (worst value). Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline BII at each scheduled post-baseline assessment was compared in terms of combination treatment (Dut plus Tam) versus tamsulosin treatment using t-tests from a general linear model with effects for treatment, country, and Baseline BII. Change from Baseline was summarized using LOCF approaches.

1 to 10 of 23Source ClinicalTrials.gov

See all 23 registered outcomes

Outcomes23

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months	Baseline and 3, 6, 9, 12, 15, 18, 21 and 24 months	ITT Population.	Score on scale	MEAN
SECONDARY	Percent Change in Prostate Volume From Baseline	Baseline,12 and 24 months	ITT Population.	Cubic centimeters (cc)	MEAN
SECONDARY	Number of Participants With IPSS Improvement From Baseline	Baseline and 3, 6, 9,12,15,18,21 and 24 months	ITT Population.	Participants	NUMBER
SECONDARY	Change From Baseline in Maximum Urine Flow Rate (Qmax) by LOCF Approach	Baseline, 6, 12, 18 and 24 Months	ITT Population	milliliter per second (mL/sec)	MEAN
SECONDARY	Number of Participants With Qmax Improvement From Baseline by LOCF Approach.	Baseline 6, 12, 18 and 24 Months	ITT Population.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery	Up to 24 Months	ITT Population.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Subjects With AUR	Up to 24 Months	ITT Population.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With BPH-related Surgery	Up to 24 Months	ITT Population.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Baseline in the BPH-related Health Status (BHS) by LOCF Approach	Baseline, 3, 6, 9, 12, 15, 18, 21 and 24 Months	ITT Population.	Scores on scale	MEAN
SECONDARY	Change From Baseline in BPH Impact Index (BII) by LOCF Approach	Baseline 3, 6, 9, 12, 15, 18, 21 and 24 Months	ITT Population.	Scores on scale	MEAN

1 to 10 of 23Source ClinicalTrials.gov

See all 23 outcomes

Results by group328

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months	Placebo + Tam 0.2mg	Month 3, n=299, 296	-4.07	Standard Error 0.34	Score on scale
Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months	Dut 0.5 mg + Tam 0.2 mg	Month 3, n=299, 296	-3.28	Standard Error 0.34	Score on scale
Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months	Placebo + Tam 0.2mg	Month 6, n=300, 298	-3.73	Standard Error 0.37	Score on scale
Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months	Dut 0.5 mg + Tam 0.2 mg	Month 6, n=300, 298	-3.36	Standard Error 0.37	Score on scale
Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months	Placebo + Tam 0.2mg	Month 9, n=300, 298	-4.14	Standard Error 0.36	Score on scale
Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months	Dut 0.5 mg + Tam 0.2 mg	Month 9, n=300, 298	-4.28	Standard Error 0.36	Score on scale
Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months	Placebo + Tam 0.2mg	Month 12,n= 300, 298	-3.93	Standard Error 0.36	Score on scale
Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months	Dut 0.5 mg + Tam 0.2 mg	Month 12,n= 300, 298	-4.30	Standard Error 0.36	Score on scale
Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months	Placebo + Tam 0.2mg	Month 15, n=300, 298	-3.95	Standard Error 0.36	Score on scale
Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months	Dut 0.5 mg + Tam 0.2 mg	Month 15, n=300, 298	-4.90	Standard Error 0.36	Score on scale

1 to 10 of 328Source ClinicalTrials.gov

See all 328 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo +Tam 0.2mg	302
Overall Study	STARTED	Dut 0.5 mg + Tam 0.2 mg	305
Overall Study	COMPLETED	Placebo +Tam 0.2mg	261
Overall Study	COMPLETED	Dut 0.5 mg + Tam 0.2 mg	251
Overall Study	NOT COMPLETED	Placebo +Tam 0.2mg	41
Overall Study	NOT COMPLETED	Dut 0.5 mg + Tam 0.2 mg	54

Source ClinicalTrials.gov

Adverse events1,126

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Nasopharyngitis	Infections and infestations	Placebo + Tam 0.2mg	30	302	46
other	Nasopharyngitis	Infections and infestations	Dut 0.5 mg + Tam 0.2 mg	37	305	45
other	Upper respiratory tract infection	Infections and infestations	Placebo + Tam 0.2mg	38	302	72
other	Upper respiratory tract infection	Infections and infestations	Dut 0.5 mg + Tam 0.2 mg	24	305	44
other	Bronchitis	Infections and infestations	Placebo + Tam 0.2mg	11	302	11
other	Bronchitis	Infections and infestations	Dut 0.5 mg + Tam 0.2 mg	8	305	8
other	Periodontitis	Infections and infestations	Placebo + Tam 0.2mg	7	302	9
other	Periodontitis	Infections and infestations	Dut 0.5 mg + Tam 0.2 mg	6	305	7
other	Conjunctivitis	Infections and infestations	Placebo + Tam 0.2mg	10	302	10
other	Conjunctivitis	Infections and infestations	Dut 0.5 mg + Tam 0.2 mg	2	305	2

1 to 10 of 1,126Source ClinicalTrials.gov

See all 1,126 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo + Tam 0.2mg	1	302
Total, all-cause mortality	Dut 0.5 mg + Tam 0.2 mg	2	305
Total, other adverse events	Placebo + Tam 0.2mg	203	302
Total, other adverse events	Dut 0.5 mg + Tam 0.2 mg	208	305
Total, serious adverse events	Placebo + Tam 0.2mg	52	302
Total, serious adverse events	Dut 0.5 mg + Tam 0.2 mg	49	305

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
30198102	BACKGROUND

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Placebo + Tam 0.2mg vs Dut 0.5 mg + Tam 0.2 mg: deaths from any cause	Trial comparisons
Placebo + Tam 0.2mg vs Dut 0.5 mg + Tam 0.2 mg: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02058368

GET https://conductscience.org/api/trials/v1/NCT02058368/registered?page=2

API reference For AI assistants