Benign Prostatic HyperplasiaNCT01404637
Effects of Tamsulosin 0.4mg on Clinical Outcomes in Korean Men With Severe Symptomatic Benign Prostatic Hyperplasia (BPH)
A study testing Tamsulosin 0.4mg and Tamsulosin 0.2mg in people with Benign Prostatic Hyperplasia, run by Samsung Medical Center.
Trial summary
The purpose of this study is to compare the efficacy and safety of tamsulosin 0.4mg (Harnal® D. 0.2mg, 2T) with tamsulosin 0.2mg (Harnal® D 0.2mg, 1T) in patients with severe symptomatic benign prostatic hyperplasia as a first line therapy. Read more about this study
- Who is it for?
- Ages 45 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Tamsulosin 0.4mg and Tamsulosin 0.2mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jul 2011to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Severe LUTS : IPSS ≥ 20
Who cannot join
- Post voided residual urine ≥ 150mL
- Patients performing catheterization
- Urinary tract infection patients
- Patients taking 5 alpha reductase inhibitor
- Known hypersensitivity to tamsulosin
- History of postural hypotension or syncope
Show all 10Show fewer
- Hypertension patients treated with other alpha1-blockers
- Patients newly taking anticholinergic medication within 1 month
- Hepatic insufficiency (AST/ALT ≥ 2 times of normal range)
- Renal insufficiency (s-Cr ≥ 2mg/dL)
About this study
Official title: The Effects of Tamsulosin 0.4mg on Clinical Outcomes in Korean Men With Severe Symptomatic BPH
The purpose of this study is to compare the efficacy and safety of tamsulosin 0.4mg (Harnal® D. 0.2mg, 2T) with tamsulosin 0.2mg (Harnal® D 0.2mg, 1T) in patients with severe symptomatic benign prostatic hyperplasia as a first line therapy.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Tamsulosin 0.4mg, Tamsulosin 0.2mg
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tamsulosin 0.4mgDrug
Treatment: tamsulosin 0.2mg (2T) /day Posology: two 0.2 mg tablet to be taken after an evening meal.
Tamsulosin 0.2mgDrug
tamsulosin 0.2mg (1T) /day Posology: one tablet to be taken after an evening meal.
| Study group | Role | What they receive |
|---|---|---|
| Tamsulosin 0.4mg | Experimental | Not described Receives: Drug: Tamsulosin 0.4mg |
| tamsulosin 0.2mg | Active comparator | Not described Receives: Drug: Tamsulosin 0.2mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of the total International Prostate Symptom Score (IPSS) score from baseline to 12 weeks of treatment in patients with severe symptomatic BPH refractory to tamsulosin 0.2mg (Harnal® 0.2mg, 1T)
Measured: 12 weeks of treatment
Secondary outcomes (2)
Changes of maximal flow rate and post-voided residual urine volume after 4 and 12 weeks treatment.
Measured: 4 weeks and 12 weeks of treatment
Changes of parameters in voiding diary after 4 and 12 weeks treatment.
Measured: 4 weeks and 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2013 (estimated)
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01404637
- Sponsor's protocol ID
- 2011-02-052
- Status last verified
- Jul 2011
- First submitted
- 26 Jul 2011
- Last updated
- 2 Aug 2011
- Results posted
- No
Publications
Kim JJ, Han DH, Sung HH, Choo SH, Lee SW. Efficacy and tolerability of tamsulosin 0.4 mg in Asian patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia refractory to tamsulosin 0.2 mg: a randomized placebo controlled trial. Int J Urol. 2014 Jul;21(7):677-82. doi: 10.1111/iju.12412. Epub 2014 Apr 13.
PubMed 24725169
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Tamsulosin 0.4mg on Clinical Outcomes in Korean Men With Severe Symptomatic BPH
- ClinicalTrials.gov ID
- NCT01404637
- Acronym / sponsor ID
- 2011-02-052
- Conditions
- Benign Prostatic Hyperplasia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 28 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the efficacy and safety of tamsulosin 0.4mg (Harnal® D. 0.2mg, 2T) with tamsulosin 0.2mg (Harnal® D 0.2mg, 1T) in patients with severe symptomatic benign prostatic hyperplasia as a first line therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tamsulosin 0.4mg | Experimental | Drug: Tamsulosin 0.4mg |
| tamsulosin 0.2mg | Active comparator | Drug: Tamsulosin 0.2mg |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Severe LUTS : IPSS ≥ 20
Key exclusion criteria (10 listed)
- Post voided residual urine ≥ 150mL
- Patients performing catheterization
- Urinary tract infection patients
- Patients taking 5 alpha reductase inhibitor
- Known hypersensitivity to tamsulosin
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 |
|---|---|---|
| Tamsulosin 0.4mgTreatment: tamsulosin 0.2mg (2T) /day Posology: two 0.2 mg tablet to be taken after an evening meal. | Drug | Tamsulosin 0.4mg |
| Tamsulosin 0.2mgtamsulosin 0.2mg (1T) /day Posology: one tablet to be taken after an evening meal. | Drug | tamsulosin 0.2mg |
Primary outcome
Changes of the total International Prostate Symptom Score (IPSS) score from baseline to 12 weeks of treatment in patients with severe symptomatic BPH refractory to tamsulosin 0.2mg (Harnal® 0.2mg, 1T)
Time frame: 12 weeks of treatment
2 secondary outcomes
Changes of maximal flow rate and post-voided residual urine volume after 4 and 12 weeks treatment.
Time frame: 4 weeks and 12 weeks of treatment
Changes of parameters in voiding diary after 4 and 12 weeks treatment.
Time frame: 4 weeks and 12 weeks of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2011.
- Derived from this study: PubMed 24725169Kim JJ, Han DH, Sung HH, Choo SH, Lee SW. Efficacy and tolerability of tamsulosin 0.4 mg in Asian patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia refractory to tamsulosin 0.2 mg: a randomized placebo controlled trial. Int J Urol. 2014 Jul;21(7):677-82. doi: 10.1111/iju.12412. Epub 2014 Apr 13.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Tamsulosin 0.4mg and Tamsulosin 0.2mg in people with Benign Prostatic Hyperplasia, run by Samsung Medical Center.
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 10 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: status not confirmed, as of the sponsor's last update on 2 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
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?
Changes of the total International Prostate Symptom Score (IPSS) score from baseline to 12 weeks of treatment in patients with severe symptomatic BPH refractory to tamsulosin 0.2mg (Harnal® 0.2mg, 1T) (time frame: 12 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01404637, which also lists 1 linked publication.
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 2 Aug 2011.