HyperplasiaPhase 3NCT01203371
Efficacy And Safety Study Of Naftopidil to Patients Treatment With LUTS
A Phase 3 study testing Naftopidil and Tamsulosin in people with Hyperplasia, run by Apsen Farmaceutica S.A. at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the effectiveness and safety of Naftopidil and Tamsulosin in the treatment of lower urinary tract symptoms through a comparative study of patients with benign prostatic hyperplasia. Read more about this study
- Who is it for?
- Ages 50 to 90 years, men only
- Conditions the study is for
- Hyperplasia
- What is being tested?
- Naftopidil and Tamsulosin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2011to 1 Jan 2012
- Phase
- Phase 3
- 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 50 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men ≥ 50 years
- Signs and symptoms of BPH
- IPSS of ≥ 10
- Prostate volume of ≥ 20 mL
- PVR > 150 mL
Who cannot join
- History of allergy to a AR antagonists
- Treatment with antiandrogen drugs
- Drugs with anticholinergic activity
- Significant history of orthostatic hypotension
- Concomitant neurological diseases
- Known or suspected neurogenic bladder dysfunction
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- Carcinoma of the prostate or bladder
- Previous surgery for BPH or bladder neck obstruction
- History of recurrent UTI
- Concomitant active UTI
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, São Paulo, 05403-010
About this study
Official title: PHASE III, DOUBLE-BLIND, RANDOMIZED STUDY COMPARING THE EFFICACY AND SAFETY OF NAFTOPIDIL AND TAMSULOSIN TO TREATMENT THE SYMPTOMS OF LOWER URINARY TRACT IN PATIENTS WITH BENIGN PROSTATE HYPERPLASIA
The purpose of this study is to evaluate the effectiveness and safety of Naftopidil and Tamsulosin in the treatment of lower urinary tract symptoms through a comparative study of patients with benign prostatic hyperplasia.
Read the detailed description
Inclusion Criteria:
Men ≥ 50 years Signs and symptoms of BPH A total IPSS of ≥ 10 Prostate volume of ≥20 mL (estimated by ultrasonography) PVR > 150mL
- Conditions
- Hyperplasia
- Being tested
- Naftopidil, Tamsulosin
- Keywords
- naftopidil, symptoms of lower urinary tract, benign prostate hyperplasia, LUTS
- Medical subject headings
- Hyperplasia, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaftopidilDrug
0,25 mg (2weeks) and 0,50 mg (10 weeks)
TamsulosinDrug
Also called SECOTEX
0,4 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Naftopidil | Experimental | 0,25 mg (2 weeks) and 0,50 mg (10 weeks) Receives: Drug: Naftopidil |
| Tamsusolin | Active comparator | 0,4 mg/day Receives: Drug: Tamsulosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Prostate Symptom Score
Measured: 2, 4, 8 and 12 weeks
Secondary outcomes (1)
Adverse Effect
Measured: 2, 4, 8 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2010 (estimated)
- Study start1 Jan 2011
- Primary completion1 Sep 2011
- Study completion1 Jan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperplasiaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apsen Farmaceutica S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01203371
- Sponsor's protocol ID
- APS 001/2010
- Other IDs
- BRA10APS001
- Status last verified
- Feb 2023
- First submitted
- 15 Sep 2010
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHASE III, DOUBLE-BLIND, RANDOMIZED STUDY COMPARING THE EFFICACY AND SAFETY OF NAFTOPIDIL AND TAMSULOSIN TO TREATMENT THE SYMPTOMS OF LOWER URINARY TRACT IN PATIENTS WITH BENIGN PROSTATE HYPERPLASIA
- ClinicalTrials.gov ID
- NCT01203371
- Acronym / sponsor ID
- APS 001/2010
- Conditions
- Hyperplasia
- Keywords
- naftopidil, symptoms of lower urinary tract, benign prostate hyperplasia, LUTS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Apsen Farmaceutica S.A.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 1 Sep 2011 (actual)
- Study completion
- 1 Jan 2012 (actual)
- First posted
- 16 Sep 2010 (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 evaluate the effectiveness and safety of Naftopidil and Tamsulosin in the treatment of lower urinary tract symptoms through a comparative study of patients with benign prostatic hyperplasia.
Detailed description
Inclusion Criteria:
Men ≥ 50 years Signs and symptoms of BPH A total IPSS of ≥ 10 Prostate volume of ≥20 mL (estimated by ultrasonography) PVR > 150mL
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naftopidil | Experimental | Drug: Naftopidil0,25 mg (2 weeks) and 0,50 mg (10 weeks) |
| Tamsusolin | Active comparator | Drug: Tamsulosin0,4 mg/day |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men ≥ 50 years
- Signs and symptoms of BPH
- IPSS of ≥ 10
- Prostate volume of ≥ 20 mL
- PVR > 150 mL
Key exclusion criteria (10 listed)
- History of allergy to a AR antagonists
- Treatment with antiandrogen drugs
- Drugs with anticholinergic activity
- Significant history of orthostatic hypotension
- Concomitant neurological diseases
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 |
|---|---|---|
| Naftopidil0,25 mg (2weeks) and 0,50 mg (10 weeks) | Drug | Naftopidil |
| TamsulosinAlso: SECOTEX0,4 mg/day | Drug | Tamsusolin |
Primary outcome
International Prostate Symptom Score
Time frame: 2, 4, 8 and 12 weeks
1 secondary outcome
Adverse Effect
Time frame: 2, 4, 8 and 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Naftopidil and Tamsulosin in people with Hyperplasia, run by Apsen Farmaceutica S.A. at 1 site in Brazil.
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 5 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: withdrawn, as of the sponsor's last update on 9 Sep 2026. 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 Brazil. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
International Prostate Symptom Score (time frame: 2, 4, 8 and 12 weeks). 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 9 Sep 2026.