BPH (Benign Prostatic Hyperplasia)Phase 4NCT07134907
The Efficacy and Safety of Qianweitai (Silodosin Capsule) Versus Tamsulosin in the Treatment of BPH
A Phase 4 study testing Silodosin and Tamsolusin in people with BPH (Benign Prostatic Hyperplasia), run by Shanghai Huilun Pharmaceutical Co., Ltd. at 6 sites in China.
Trial summary
The goal of this clinical trial is to learn if Qianweitai (QWT, silodosin capsule) works to treat BPH/LUTS in male adults. It will also learn the safety about QWT. The main questions it aims to answer are: 1. Whether QWT is non inferior to tamsulosin in the reduction of IPSS total score？ 2. Read more about this study
- Who is it for?
- Ages 60 to 80 years, men only
- Conditions the study is for
- BPH (Benign Prostatic Hyperplasia)
- What is being tested?
- Silodosin and Tamsolusin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 6 sitesChina
- Study dates
- 18 Jul 2022to 9 Jul 2024
- Phase
- Phase 4
- 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 60 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male Subjects aged 60 ～ 80 years, clinically diagnosed as benign prostatic hyperplasia.
- Has an IPSS score ≥ 8 points at Screening and Baseline.
- Has a 4 ≤ Qmax ≤ 15 ml/s when urination volume > 150 ml.
- Has a prostate volume (PV) ≥ 30 ml by ultrasound examination.
- Subjects who can read, understand, and complete the research questionnaire.
- Subjects willing to participate voluntarily in this clinical trial, give informed consent and sign informed consent.
Who cannot join
- Subjects with prostate cancer or other malignant tumors.
- Subjects have serum tPSA > 10ng/ml, or 4 ≤ tPSA ≤ 10ng/ml while fPSA/tPSA < 0.16 times.
- Subjects suffered from other diseases causing dysuria, such as bladder neck spasm, urethral stricture, neurogenic bladder dysfunction, etc.
- Subjects have suffered from acute urinary retention, or complicated with gross hematuria, urinary tract infection, bladder stones, secondary upper urinary tract hydronephrosis, urinary incontinence, renal insufficiency and other Subjects that researchers believe meet the surgical indications.
- Subjects have undergone prostate surgery, microwave therapy, urethral dilatation or acute urinary retention catheterization or other invasive procedures.
- Subjects have residual urine volume (PVR) > 100ml, or those who may have urinary retention and need catheterization.
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- Subjects who took α receptor blockers, traditional Chinese medicine or botanical drugs for treating BPH within two weeks before participating this clinical trial.
- Subjects who take 5α reductase inhibitor or other antiandrogen therapy drugs within half a year before participating this clinical trial.
- Subjects who need to take drugs prohibited in this study or adopt prohibited treatment methods during treatment.
- Subjects who Complicated with severe cardiovascular and cerebrovascular diseases, respiratory diseases, blood diseases, liver and kidney diseases.
- There are significant abnormalities in clinical or laboratory examination indexes of patients, such as ALT and AST ≥ 2.5 times of the upper limit of reference value, creatinine (Scr) > 1.5 times of the upper limit of reference value, or poor blood glucose control (fasting blood glucose FPG ≥ 10 mmol/L).
- Subjects who are allergic to the drugs or ingredients used in the test definitely.
- Any otherSubjects in the opinion of researchers is not suitable for inclusion.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Beijing Tongren Hospital, Capital Medical University
Beijing
Ciivil Aviation General Hospital
Beijing
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui
The Second Affiliated Hospital of Suzhou University
Suzhou, Jiangsu
Wuhan Center Hospital
Wuhan, Hubei
Wuhan No.1 Hospital
Wuhan, Hubei
About this study
Official title: The Efficacy and Safety of Qianweitai (Silodosin Capsule) Compared to Tamsulosin in the Treatment of Benign Prostaic Hyperplasia (BPH) -A Multicenter, Prospecive, Randomized, Investigator-Blind, Positive-Controlled Study
The goal of this clinical trial is to learn if Qianweitai (QWT, silodosin capsule) works to treat BPH/LUTS in male adults. It will also learn the safety about QWT. The main questions it aims to answer are:
- Whether QWT is non inferior to tamsulosin in the reduction of IPSS total score？
- Dose QWT have other advantages in the improvement of LUTS?
Participants will:
- Orally take QWT twice daily or tamsulosin once daily for 12 weeks.
- Visit the clinic at week 1、 2、4、8 and 12 for checkups and tests.
Read the detailed description
This trial is designed as two stages: screening period, treatment and follow-up period.
Screening period (days -28 to 0): After signing the informed consent form, the subjects entered into the screening period, and made a 24-hour urination diary and screening examination.
Treatment and Follow-up period: eligible patients were randomly assigned to 2 groups according to 1: 1 and received Tamsulosin or Silodosin or for 12 weeks. During the treatment period, the subjects' diaries were recorded according to the requirements of the scheme, and they were followed up at 1 week (7±2 days), 2 weeks (14±3), 4 weeks (28±5 days), 8 weeks (56±7 days) and 12 weeks (84±10 days). During the visit, relevant scale scores and laboratory examinations were performed, and the occurrence of adverse events during the follow-up was recorded to evaluate the safety.
- Conditions
- BPH (Benign Prostatic Hyperplasia)
- Being tested
- Silodosin, Tamsolusin
- Keywords
- Benign Prostatic Hyperplasia, Qianweitai, Tamsulosin, Lower Urinary Tract Symptoms
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SilodosinDrug
Also called Qianweitai
Silodosin is an α1A-adrenergic receptor antagonist which can relax the smooth muscle of bladder and prostate, relieve the dynamic obstruction of bladder outlet, and improve the lower urinary tract symptoms caused by BPH. The instruction of Silodosin Capsule (Qianweitai®) is 4mg/capsule，1 capsule/time, bid, after breakfast and dinner.
TamsolusinDrug
Also called Harnal
Tamsulosin is an α1A-adrenergic receptor blocker which has used in treatment of BPH for few years. The instruction of Tamsulosin Capsule is 1 tablet at a time, 1 time a day.
| Study group | Role | What they receive |
|---|---|---|
| Qianweitai | Experimental | Patients orally take Qianweitai (silodosin capsule), 4mg/capsule, 1 capsule/time, bid, after breakfast and dinner). Receives: Drug: Silodosin |
| Tamsulosin | Active comparator | Patients orally take tamsulosin hydrochloride capsules (1 tablet each time, once daily). Receives: Drug: Tamsolusin |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Prostate Symptom Score（IPSS）
Changes of IPSS scores at the 12th week of treatment compared with baseline scores.
Measured: week 12
Secondary outcomes (11)
International Prostate Symptom Score（IPSS） total score
Changes of IPSS scores at 1, 2, 4 and 8 weeks after treatment compared with baseline
Measured: 1, 2, 4 and 8 weeks
IPSS storage subscore
Changes of IPSS storage subscore at 1, 2, 4 and 8 weeks after treatment compared with baseline
Measured: 1, 2, 4 and 8 weeks
IPSS voiding subscore
Changes of IPSS voiding subscore at 1, 2, 4 and 8 weeks after treatment compared with baseline
Measured: 1, 2, 4 and 8 weeks
IPSS total score severity
Proportion of patients with IPSS total score severity decreased by at least one grade at 12 weeks. The scores of the scale were divided into three grades: mild (0-7), moderate (8-19) and severe (20-35).
Measured: week 12
Quality of life (QoL) score
Changes in scores at 4, 8 and 12 weeks of treatment compared with baseline.The scores of the scale ranged from 0 to 6. The higher the score, the more severe the symptoms are.
Measured: 4, 8 and 12 weeks
Maximum urinary flow rate (Qmax)
The change of Qmax at the 12th week of treatment compared with baseline.
Measured: week 12
Residual urine volume (PVR)
The change of PVR at the 12th week of treatment compared with baseline.
Measured: week 12
Prostate specific antigen (PSA)
The change of PSA at the 12th week of treatment compared with baseline.
Measured: week 12
Prostate volume (PV)
Changes of PV at 12 the 12th week of treatment compared with baseline.
Measured: week 12
Responder rate
Responder rate is defined as the proportion of patients whose IPSS total score decreased by ≥ 25% and Qmax increased by ≥ 30% compared with baseline value after treatment.
Measured: week 12
Proportion of patients with BPH clinical progression
Clinical progress is defined as the first occurrence of one of the following two conditions during the trial:
- Acute urinary retention (AUR);
- Clinical diagnosis requires surgical treatment of BPH.
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start18 Jul 2022
- Primary completion9 Jul 2024
- Study completion9 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPH (Benign Prostatic Hyperplasia)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Huilun Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shan Chen, Principal investigator, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07134907
- Sponsor's protocol ID
- NM-22-A-001-YJ-001
- Status last verified
- Aug 2025
- First submitted
- 14 Aug 2025
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Qianweitai (Silodosin Capsule) Compared to Tamsulosin in the Treatment of Benign Prostaic Hyperplasia (BPH) -A Multicenter, Prospecive, Randomized, Investigator-Blind, Positive-Controlled Study
- ClinicalTrials.gov ID
- NCT07134907
- Acronym / sponsor ID
- NM-22-A-001-YJ-001
- Conditions
- BPH (Benign Prostatic Hyperplasia)
- Keywords
- Benign Prostatic Hyperplasia, Qianweitai, Tamsulosin, Lower Urinary Tract Symptoms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Shanghai Huilun Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 9 Jul 2024 (actual)
- Study completion
- 9 Jul 2024 (actual)
- First posted
- 21 Aug 2025 (actual)
- 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 goal of this clinical trial is to learn if Qianweitai (QWT, silodosin capsule) works to treat BPH/LUTS in male adults. It will also learn the safety about QWT. The main questions it aims to answer are:
- Whether QWT is non inferior to tamsulosin in the reduction of IPSS total score？
- Dose QWT have other advantages in the improvement of LUTS?
Participants will:
- Orally take QWT twice daily or tamsulosin once daily for 12 weeks.
- Visit the clinic at week 1、 2、4、8 and 12 for checkups and tests.
Detailed description
This trial is designed as two stages: screening period, treatment and follow-up period.
Screening period (days -28 to 0): After signing the informed consent form, the subjects entered into the screening period, and made a 24-hour urination diary and screening examination.
Treatment and Follow-up period: eligible patients were randomly assigned to 2 groups according to 1: 1 and received Tamsulosin or Silodosin or for 12 weeks. During the treatment period, the subjects' diaries were recorded according to the requirements of the scheme, and they were followed up at 1 week (7±2 days), 2 weeks (14±3), 4 weeks (28±5 days), 8 weeks (56±7 days) and 12 weeks (84±10 days). During the visit, relevant scale scores and laboratory examinations were performed, and the occurrence of adverse events during the follow-up was recorded to evaluate the safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Qianweitai | Experimental | Drug: SilodosinPatients orally take Qianweitai (silodosin capsule), 4mg/capsule, 1 capsule/time, bid, after breakfast and dinner). |
| Tamsulosin | Active comparator | Drug: TamsolusinPatients orally take tamsulosin hydrochloride capsules (1 tablet each time, once daily). |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male Subjects aged 60 ～ 80 years, clinically diagnosed as benign prostatic hyperplasia.
- Has an IPSS score ≥ 8 points at Screening and Baseline.
- Has a 4 ≤ Qmax ≤ 15 ml/s when urination volume > 150 ml.
- Has a prostate volume (PV) ≥ 30 ml by ultrasound examination.
- Subjects who can read, understand, and complete the research questionnaire.
Key exclusion criteria (13 listed)
- Subjects with prostate cancer or other malignant tumors.
- Subjects have serum tPSA > 10ng/ml, or 4 ≤ tPSA ≤ 10ng/ml while fPSA/tPSA < 0.16 times.
- Subjects suffered from other diseases causing dysuria, such as bladder neck spasm, urethral stricture, neurogenic bladder dysfunction, etc.
- Subjects have suffered from acute urinary retention, or complicated with gross hematuria, urinary tract infection, bladder stones, secondary upper urinary tract hydronephrosis, urinary incontinence, renal insufficiency and other Subjects that researchers believe meet the surgical indications.
- Subjects have undergone prostate surgery, microwave therapy, urethral dilatation or acute urinary retention catheterization or other invasive procedures.
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 |
|---|---|---|
| SilodosinAlso: QianweitaiSilodosin is an α1A-adrenergic receptor antagonist which can relax the smooth muscle of bladder and prostate, relieve the dynamic obstruction of bladder outlet, and improve the lower urinary tract symptoms caused by BPH. The instruction of Silodosin Capsule (Qianweitai®) is 4mg/capsule，1 capsule/time, bid, after breakfast and dinner. | Drug | Qianweitai |
| TamsolusinAlso: HarnalTamsulosin is an α1A-adrenergic receptor blocker which has used in treatment of BPH for few years. The instruction of Tamsulosin Capsule is 1 tablet at a time, 1 time a day. | Drug | Tamsulosin |
Primary outcome
International Prostate Symptom Score（IPSS）
Time frame: week 12
Changes of IPSS scores at the 12th week of treatment compared with baseline scores.
11 secondary outcomes
International Prostate Symptom Score（IPSS） total score
Time frame: 1, 2, 4 and 8 weeks
IPSS storage subscore
Time frame: 1, 2, 4 and 8 weeks
IPSS voiding subscore
Time frame: 1, 2, 4 and 8 weeks
IPSS total score severity
Time frame: week 12
Quality of life (QoL) score
Time frame: 4, 8 and 12 weeks
Maximum urinary flow rate (Qmax)
Time frame: week 12
Residual urine volume (PVR)
Time frame: week 12
Prostate specific antigen (PSA)
Time frame: week 12
Prostate volume (PV)
Time frame: week 12
Responder rate
Time frame: week 12
Proportion of patients with BPH clinical progression
Time frame: week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
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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.
Shan Chen principal investigator
Beijing Tongren Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Silodosin and Tamsolusin in people with BPH (Benign Prostatic Hyperplasia), run by Shanghai Huilun Pharmaceutical Co., Ltd. at 6 sites in China.
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 6 inclusion and 13 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: finished, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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（IPSS） (time frame: week 12). 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 21 Aug 2025.