Prostatic HyperplasiaPhase 4FDC114785NCT01673490
Safety and Efficacy of 0.5mg Dutasteride and 0.4mg Tamsulosin Combination Once Daily for Six Months for Benign Prostatic Hyperplasia
A Phase 4 study testing Dutasteride/Tamsulosin in people with Prostatic Hyperplasia, run by GlaxoSmithKline at 1 site in Vietnam.
Trial summary
Open-label, 6 month-treatment with the IP in all subjects. - Sample size: A total of 90 subjects will be enrolled so that among them at least 57 will complete the 6-month treatment period and evaluable for analysis. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Prostatic Hyperplasia
- What is being tested?
- Dutasteride/Tamsulosin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteVietnam
- Study dates
- 29 Jun 2012to 20 Mar 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male, age ≥ 50 years. Clinical diagnosis of benign prostate hypertrophy (BPH) . International Prostate Symptom Score (IPSS) ≥ 12 Prostate volume ≥30 ml (transrectal ultrasonography). Total serum prostate specific antigen (PSA) ≥1.5 ng/mL and ≤10 ng/mL. Free-to-total PSA ratio > 20% Maximum flow rate (Qmax) >5 mL/sec and ≤15 mL/sec and post-void residual volume of < 150 mL Willing and able to give written informed consent and comply with study procedures throughout study Able to swallow and retain oral medication Able to express personal thought and feeling Ability to read and comprehend information on the Sexual Function Inventory
Who cannot join
- History or evidence of prostate cancer (e.g. positive biopsy or ultrasound, suspicious digital rectal examination).
- Previous prostatic surgery (TURP, balloon dilatation, thermotherapy and stent replacement) or other invasive procedures to treat BPH.
- History of flexible/rigid cystoscopy or other instrumentation of the urethra within past 7 days History of acute urine retention (AUR) within past 3 months. Any causes other than BPH result in urinary symptoms or changes in flow rate (e.g. neurogenic bladder, bladder neck contracture, urethral stricture, bladder malignancy, acute or chronic prostatitis, acute or chronic urinary tract infections).
- History of breast cancer or clinical finding suggestive of malignancy. Use of any 5-alpha-reductase inhibitor (e.g. Proscar®, Propecia®), drugs with antiandrogenic properties (e.g. spironolactone, flutamide, bicalutamide, cimetidine, ketoconazole, progestational agents), drugs which induce gynecomastia or drugs which affect prostate volume, within past 6 months and throughout the study (other than as study medication). Do not use dutasteride within past 12 months. Do not use metronidazole for a long time.
- Concurrent use of anabolic steroids (eg. Durabolin®). Use of phytotherapy (eg: Tadenan®, Permixon®, etc) for BPH within 2 weeks of screening visit and/or predicted to need phytotherapy during the study.
- Use of any alpha-adrenoreceptor blockers (i.e. indoramin, prazosin, terazosin, tamsulosin, alfuzosin and doxazosin) within 2 weeks of screening visit and/or predicted to need any alpha blockers other than tamsulosin during the study.
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- Use of any alpha-adrenoreceptor agonists (e.g. pseudoephedrine, phenylephrine, ephedrine) or anticholinergics (e.g. oxybutynin, propantheline) or cholinergics (e.g. bethanecol chloride) within 48 hours prior to all uroflowmetry assessments.
- Hypersensitivity to any alpha-/beta-adrenoreceptor blocker or 5-alpha-reductase inhibitor, or other chemically-related drugs.
- Concurrent use of drugs known or thought to have an interaction with tamsulosin and dutasteride.
- History of hepatic impairment or abnormal liver function tests at screening (defined ALT, AST, and/or alkaline phosphatase >2 times the upper limit of normal, or total bilirubin >1.5 times the upper limit of normal).
- History of renal insufficiency, or serum creatinine >1.5 times the upper limit of normal at screening.
- History of malignancies other than basal cell carcinoma or squamous cell carcinoma of the skin within the past 5 years. Subjects with a prior malignancy who have had no evidence of disease for at least 5 years prior to screening are eligible.
- Any unstable, serious co-existing medical condition(s) including, but not limited to, myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within past 6 months; medically uncontrollable diabetes or peptic ulcer disease History of postural hypotension, dizziness, vertigo or any signs and symptoms of orthostasis, which in judgments of investigator, could be exacerbated by tamsulosin History of unsuccessful treatment with tamsulosin or 'first dose' hypotensive episode on initiation of alpha-1-adrenoreceptor antagonist therapy.
- History of unsuccessful treatment with finasteride or dutasteride. Willing to have a child during the treatment period or within 6 months thereafter Having female partner who is a pregnant woman or in child-bearing age and refuse to use condom for sexual protection Willing to donate blood during treatment period or within 6 months thereafter. History or current evidence of drug or alcohol abuse within past 12 months. History of any illness might confound the results of the study or poses additional risk to the patient.
- Participation in investigational or marketed drug trial within 30 days preceding the screening visit and/or during the study treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pivotal, Open-label Trial Assessing the Safety and Efficacy of the 0.5 mg Dutasteride and 0.4 mg Tamsulosin Combination Once Daily for Six Months in Patients With Benign Prostatic Hyperplasia
Open-label, 6 month-treatment with the IP in all subjects. - Sample size: A total of 90 subjects will be enrolled so that among them at least 57 will complete the 6-month treatment period and evaluable for analysis.
-Primary objective: To assess the safety of 0.5 mg dutasteride/0.4 mg tamsulosin combination therapy for six month in BPH patients by monitoring category, frequency and severity of adverse events encountered during the treatment period.
-Secondary objective: To assess the efficacy of 0.5 mg dutasteride/0.4 mg tamsulosin combination therapy with regard to symptom improvement in BPH patients by monitoring and analyzing of changes in IPSS and Qmax after 6 months of treatment.
Read the detailed description
Visit 0 or Screening Visit (M0) - D0 + 2): Following tasks will be performed: ICF collection, subject code assignment, physical examination (vital signs, demographic data, medical history); checking of inclusion and exclusion criteria: prostate symptom score according to IPSS, laboratory tests (hematology, blood chemistry, electrolytes, total PSA level, free-to-total PSA ratio, Qmax, urinalysis, transrectal prostate ultrasonography (TRUS), 12-lead electrocardiography (ECG), scoring of Sexual Function Questionnaire (SFQ), concomitant medication assessment, IP dispensing. • Visit 1 (Month 1 (M1) - D30 ± 3): Following items will be recorded: treatment compliance, vital signs, blood chemistry, ECG, adverse events (AEs), concomitant medication; dispensing of new IP doses and collecting of dispensed IP at the last visit. • Visit 2 (Month 2 (M2) - D60 ± 3): Following items will be recorded: treatment compliance, AEs, concomitant medication; dispensing of new IP doses and collecting of dispensed IP at the last visit. • Visit 3 (Month 3 (M3) - D90 ± 3): Following items will be recorded: vital signs, laboratory tests (hematology, blood chemistry, electrolytes, Qmax, urinalysis, 12-lead ECG, total PSA level), concomitant medication, SFQ score, AE assessment, collecting of dispensed IP at the last visit and dispensing of new IP doses. • Visit 4 (Month 4.5 (M4) - D135 ± 3): Following items will be recorded: treatment compliance, vital signs, AEs, concomitant medication; dispensing of new IP doses and collecting of dispensed IP at the last visit. Visit 5 (Month 6 (M6)- D180 ± 3): Following items will be recorded: treatment compliance, vital signs, prostate symptom score according to IPSS, laboratory tests (hematology, blood chemistry, electrolytes, Qmax, urinalysis, 12-lead ECG, total PSA level, free-to-total PSA ratio, TRUS; concomitant medication, SFQ score, AE assessment, collecting of the previous dispensed IPs . Follow-up Phone Call (Month 7 (M7)- D210 ± 3): To record any possible AE that may occur after discontinuation of study treatment.
- Conditions
- Prostatic Hyperplasia
- Being tested
- Dutasteride/Tamsulosin
- Keywords
- Benign Prostatic Hyperplasia, dutasteride and tamsulosin
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dutasteride/TamsulosinDrug
Also called Duodart, combodart
0.5 mg dutasteride/ 0.4 mg tamsulosin once daily for the duration of 180 day -treatment
| Study group | Role | What they receive |
|---|---|---|
| Combodart/Duodart | Experimental | Single arm testing the efficacy/safety of the combinnation of Dutasteride/Tamsulosin Receives: Drug: Dutasteride/Tamsulosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Any On-treatment Adverse Events (AEs) or Any Serious Adverse Event (SAEs) and Treatment-related AEs
An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product at any dose, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, and is associated with liver injury and impaired liver function.
Measured: From start of study medication until follow-up (up to 7 months)
Number of Participants With Any Post-treatment Adverse Events (AEs) or Any Serious Adverse Event (SAEs) and Treatment-related AEs
An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product at any dose, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, and is associated with liver injury and impaired liver function.
Measured: From start of study medication until follow-up (up to 7 months)
Number of Participants With Abnormal Electrocardiogram (ECG) Findings at the Indicated Time Points
A 12 lead ECG was measured at Screening, Month 1 (Visit 1), Month 3 (Visit 3) and Month 6 (Visit 5).
Measured: Screening, Month 1, Month 3 and Month 6
Number of Participants With Clinical Chemistry Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline
Blood samples were collected at Screening, Month 1 (Visit 1), Month 3 (Visit 3) and Month 6 (Visit 5) for chemistry laboratory assessments. Clinical chemistry parameters included alanine aminotrasferase (ALT), aspartate aminotrasferase (AST), creatinine, glucose, potassium, protein, sodium and urea. The number of participants with a shift from normal at Baseline to abnormal at any time post-Baseline for a clinical chemistry parameter are summarized.
Measured: Screening, Month 1, Month 3 and Month 6
Number of Participants With Hematology Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline
Blood samples were collected at Screening, Month 3 (Visit 3) and Month 6 (Visit 5) for hematology laboratory assessments. Hematology parameters included basophils, leukocytes, hemoglobin (HGB), eosinophils, erythrocytes (ery), ery mean Corpuscular HGB concentration, ery mean corpuscular HGB, ery distribution width, lymphocytes, hematocrit, monocytes, neutrophils and platelets. The number of participants with a shift from normal at Baseline to abnormal at any time post-Baseline for hematology parameters are summarized.
Measured: Screening, Month 3 and Month 6
Number Participants With a Negative or Positive Response at the Indicated Time Points
Urine samples were collected at Screening (SC), Month 3 (3M) and Month 6 (6M) for urinalysis laboratory assesment. Final value (FV) is defined as the latest post-Baseline value available in the study for each parameter.Urinalysis parameters included erythrocytes, glucose, ketones, leukocytes and protein. Number of participants with a negative (NEG) or positive (POS) response at the indicated time points are summarized.
Measured: Screening, Month 3 and Month 6
Change From Baseline in Total Prostate -Specific Antigen (PSA) at the Indicated Time Points
Serum sample was collected at Baseline, Month 3 and Month 6 for assesment of total PSA. PSA is a substance produced by prostate gland, and the elevated level of PSA indicates prostate cancer or any other non-cancerous condition related to prostate. Change from Baseline in total PSA at Month 3 and Month 6 was calculated as value at specified visist minus Baseline value.
Measured: Baseline, Month 3 and Month 6
Free to Total PSA Ratio at the Indicated Time Points
Serum sample was collected at Screening (Baseline for participants with Free to Total PSA ratio at Month 6), and Month 6 for assessment of free to total PSA ratio. PSA is a substance produced by prostate gland, and the elevated level of PSA indicates prostate cancer or any other non-cancerous condition related to prostate. Free to total PSA ratio at Baseline for participants with free to total PSA Ratio at Month 6 and free to total PSA ratio at month 6 are presented.
Measured: Baseline, Month 6
Secondary outcomes (2)
Change From Baseline in the International Prostate Symptom Score (IPSS) at Month 6
The IPSS is a screening tool used to assess the symptoms of prostate related disease. The IPSS questionnaire consists of seven symptoms questions including feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia, each referring to during the last month, and each involving assignment of a score from 0 to 5 (no symptoms to almost always symptoms) for a total of maximum 35 points. IPSS total is the sum of the scores of seven questions; therefore, the possible total score ranges from 0 to 35 (0-7: Mildly symptomatic; 8-19: Moderately symptomatic; 20-35: Severely symptomatic). IPSS was assessed at Baseline and Month 6. Change from Baseline was calculated as Month 6 IPSS score- minus Baseline IPSS score.
Measured: Baseline and Month 6
Change From Baseline in Maximum Rate of Urinary Flow (Qmax) at the Indicated Time Points
The Qmax is used as an indicator for the diagnosis of enlarged prostate. A lower Qmax may indicate that the enlarged prostate. Qmax was assessed at Baseline (screening), Month 3 and Month 6. Change from Baseline was calculated as Qmax score at specified timepoint minus the Baseline Qmax score.
Measured: Baseline, Month 3 and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2012 (estimated)
- Study start29 Jun 2012
- Primary completion20 Mar 2015
- Study completion20 Mar 2015
Why it stopped: The sole investigative site refused to accept the amended protocol and declined to continue the study. There was no safety signal nor any other reason.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673490
- Sponsor's protocol ID
- 114785
- Acronym
- FDC114785
- Status last verified
- Jul 2018
- First submitted
- 28 Jun 2012
- Last updated
- 20 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal, Open-label Trial Assessing the Safety and Efficacy of the 0.5 mg Dutasteride and 0.4 mg Tamsulosin Combination Once Daily for Six Months in Patients With Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT01673490
- Acronym / sponsor ID
- FDC114785 / 114785
- Conditions
- Prostatic Hyperplasia
- Keywords
- Benign Prostatic Hyperplasia, dutasteride and tamsulosin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The sole investigative site refused to accept the amended protocol and declined to continue the study. There was no safety signal nor any other reason.
- Enrolment
- 59 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2012 (actual)
- Primary completion
- 20 Mar 2015 (actual)
- Study completion
- 20 Mar 2015 (actual)
- First posted
- 28 Aug 2012 (estimated)
- Results
- Posted 17 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open-label, 6 month-treatment with the IP in all subjects. - Sample size: A total of 90 subjects will be enrolled so that among them at least 57 will complete the 6-month treatment period and evaluable for analysis.
-Primary objective: To assess the safety of 0.5 mg dutasteride/0.4 mg tamsulosin combination therapy for six month in BPH patients by monitoring category, frequency and severity of adverse events encountered during the treatment period.
-Secondary objective: To assess the efficacy of 0.5 mg dutasteride/0.4 mg tamsulosin combination therapy with regard to symptom improvement in BPH patients by monitoring and analyzing of changes in IPSS and Qmax after 6 months of treatment.
Detailed description
Visit 0 or Screening Visit (M0) - D0 + 2): Following tasks will be performed: ICF collection, subject code assignment, physical examination (vital signs, demographic data, medical history); checking of inclusion and exclusion criteria: prostate symptom score according to IPSS, laboratory tests (hematology, blood chemistry, electrolytes, total PSA level, free-to-total PSA ratio, Qmax, urinalysis, transrectal prostate ultrasonography (TRUS), 12-lead electrocardiography (ECG), scoring of Sexual Function Questionnaire (SFQ), concomitant medication assessment, IP dispensing. • Visit 1 (Month 1 (M1) - D30 ± 3): Following items will be recorded: treatment compliance, vital signs, blood chemistry, ECG, adverse events (AEs), concomitant medication; dispensing of new IP doses and collecting of dispensed IP at the last visit. • Visit 2 (Month 2 (M2) - D60 ± 3): Following items will be recorded: treatment compliance, AEs, concomitant medication; dispensing of new IP doses and collecting of dispensed IP at the last visit. • Visit 3 (Month 3 (M3) - D90 ± 3): Following items will be recorded: vital signs, laboratory tests (hematology, blood chemistry, electrolytes, Qmax, urinalysis, 12-lead ECG, total PSA level), concomitant medication, SFQ score, AE assessment, collecting of dispensed IP at the last visit and dispensing of new IP doses. • Visit 4 (Month 4.5 (M4) - D135 ± 3): Following items will be recorded: treatment compliance, vital signs, AEs, concomitant medication; dispensing of new IP doses and collecting of dispensed IP at the last visit. Visit 5 (Month 6 (M6)- D180 ± 3): Following items will be recorded: treatment compliance, vital signs, prostate symptom score according to IPSS, laboratory tests (hematology, blood chemistry, electrolytes, Qmax, urinalysis, 12-lead ECG, total PSA level, free-to-total PSA ratio, TRUS; concomitant medication, SFQ score, AE assessment, collecting of the previous dispensed IPs . Follow-up Phone Call (Month 7 (M7)- D210 ± 3): To record any possible AE that may occur after discontinuation of study treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combodart/Duodart | Experimental | Drug: Dutasteride/TamsulosinSingle arm testing the efficacy/safety of the combinnation of Dutasteride/Tamsulosin |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male, age ≥ 50 years. Clinical diagnosis of benign prostate hypertrophy (BPH) . International Prostate Symptom Score (IPSS) ≥ 12 Prostate volume ≥30 ml (transrectal ultrasonography). Total serum prostate specific antigen (PSA) ≥1.5 ng/mL and ≤10 ng/mL. Free-to-total PSA ratio > 20% Maximum flow rate (Qmax) >5 mL/sec and ≤15 mL/sec and post-void residual volume of < 150 mL Willing and able to give written informed consent and comply with study procedures throughout study Able to swallow and retain oral medication Able to express personal thought and feeling Ability to read and comprehend information on the Sexual Function Inventory
Key exclusion criteria (15 listed)
- History or evidence of prostate cancer (e.g. positive biopsy or ultrasound, suspicious digital rectal examination).
- Previous prostatic surgery (TURP, balloon dilatation, thermotherapy and stent replacement) or other invasive procedures to treat BPH.
- History of flexible/rigid cystoscopy or other instrumentation of the urethra within past 7 days History of acute urine retention (AUR) within past 3 months. Any causes other than BPH result in urinary symptoms or changes in flow rate (e.g. neurogenic bladder, bladder neck contracture, urethral stricture, bladder malignancy, acute or chronic prostatitis, acute or chronic urinary tract infections).
- History of breast cancer or clinical finding suggestive of malignancy. Use of any 5-alpha-reductase inhibitor (e.g. Proscar®, Propecia®), drugs with antiandrogenic properties (e.g. spironolactone, flutamide, bicalutamide, cimetidine, ketoconazole, progestational agents), drugs which induce gynecomastia or drugs which affect prostate volume, within past 6 months and throughout the study (other than as study medication). Do not use dutasteride within past 12 months. Do not use metronidazole for a long time.
- Concurrent use of anabolic steroids (eg. Durabolin®). Use of phytotherapy (eg: Tadenan®, Permixon®, etc) for BPH within 2 weeks of screening visit and/or predicted to need phytotherapy during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dutasteride/TamsulosinAlso: Duodart, combodart0.5 mg dutasteride/ 0.4 mg tamsulosin once daily for the duration of 180 day -treatment | Drug | Combodart/Duodart |
Primary outcome
Number of Participants With Any On-treatment Adverse Events (AEs) or Any Serious Adverse Event (SAEs) and Treatment-related AEs
Time frame: From start of study medication until follow-up (up to 7 months)
An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product at any dose, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, and is associated with liver injury and impaired liver function.
Number of Participants With Any Post-treatment Adverse Events (AEs) or Any Serious Adverse Event (SAEs) and Treatment-related AEs
Time frame: From start of study medication until follow-up (up to 7 months)
An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product at any dose, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, and is associated with liver injury and impaired liver function.
Number of Participants With Abnormal Electrocardiogram (ECG) Findings at the Indicated Time Points
Time frame: Screening, Month 1, Month 3 and Month 6
A 12 lead ECG was measured at Screening, Month 1 (Visit 1), Month 3 (Visit 3) and Month 6 (Visit 5).
Number of Participants With Clinical Chemistry Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline
Time frame: Screening, Month 1, Month 3 and Month 6
Blood samples were collected at Screening, Month 1 (Visit 1), Month 3 (Visit 3) and Month 6 (Visit 5) for chemistry laboratory assessments. Clinical chemistry parameters included alanine aminotrasferase (ALT), aspartate aminotrasferase (AST), creatinine, glucose, potassium, protein, sodium and urea. The number of participants with a shift from normal at Baseline to abnormal at any time post-Baseline for a clinical chemistry parameter are summarized.
Number of Participants With Hematology Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline
Time frame: Screening, Month 3 and Month 6
Blood samples were collected at Screening, Month 3 (Visit 3) and Month 6 (Visit 5) for hematology laboratory assessments. Hematology parameters included basophils, leukocytes, hemoglobin (HGB), eosinophils, erythrocytes (ery), ery mean Corpuscular HGB concentration, ery mean corpuscular HGB, ery distribution width, lymphocytes, hematocrit, monocytes, neutrophils and platelets. The number of participants with a shift from normal at Baseline to abnormal at any time post-Baseline for hematology parameters are summarized.
Number Participants With a Negative or Positive Response at the Indicated Time Points
Time frame: Screening, Month 3 and Month 6
Urine samples were collected at Screening (SC), Month 3 (3M) and Month 6 (6M) for urinalysis laboratory assesment. Final value (FV) is defined as the latest post-Baseline value available in the study for each parameter.Urinalysis parameters included erythrocytes, glucose, ketones, leukocytes and protein. Number of participants with a negative (NEG) or positive (POS) response at the indicated time points are summarized.
Change From Baseline in Total Prostate -Specific Antigen (PSA) at the Indicated Time Points
Time frame: Baseline, Month 3 and Month 6
Serum sample was collected at Baseline, Month 3 and Month 6 for assesment of total PSA. PSA is a substance produced by prostate gland, and the elevated level of PSA indicates prostate cancer or any other non-cancerous condition related to prostate. Change from Baseline in total PSA at Month 3 and Month 6 was calculated as value at specified visist minus Baseline value.
Free to Total PSA Ratio at the Indicated Time Points
Time frame: Baseline, Month 6
Serum sample was collected at Screening (Baseline for participants with Free to Total PSA ratio at Month 6), and Month 6 for assessment of free to total PSA ratio. PSA is a substance produced by prostate gland, and the elevated level of PSA indicates prostate cancer or any other non-cancerous condition related to prostate. Free to total PSA ratio at Baseline for participants with free to total PSA Ratio at Month 6 and free to total PSA ratio at month 6 are presented.
2 secondary outcomes
Change From Baseline in the International Prostate Symptom Score (IPSS) at Month 6
Time frame: Baseline and Month 6
Change From Baseline in Maximum Rate of Urinary Flow (Qmax) at the Indicated Time Points
Time frame: Baseline, Month 3 and Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- IPD for this study will be made available via the Clinical Study Data Request site.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dutasteride/Tamsulosin in people with Prostatic Hyperplasia, run by GlaxoSmithKline at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Any On-treatment Adverse Events (AEs) or Any Serious Adverse Event (SAEs) and Treatment-related AEs (time frame: From start of study medication until follow-up (up to 7 months)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2018.