Status:
COMPLETED
The Efficacy and Safety of Qianweitai (Silodosin Capsule) Versus Tamsulosin in the Treatment of BPH
Lead Sponsor:
Shanghai Huilun Pharmaceutical Co., Ltd.
Conditions:
BPH (Benign Prostatic Hyperplasia)
Eligibility:
MALE
60-80 years
Phase:
PHASE4
Brief 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...
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 screen...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
July 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 9 2024
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT07134907
Start Date
July 18 2022
End Date
July 9 2024
Last Update
August 21 2025
Active Locations (6)
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1
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
2
Wuhan Center Hospital
Wuhan, Hubei, China
3
Wuhan No.1 Hospital
Wuhan, Hubei, China
4
The Second Affiliated Hospital of Suzhou University
Suzhou, Jiangsu, China