Benign Prostatic Hyperplasia Clinical Trial
— CVOfficial title:
Observational Study to Evaluate Effect of Thrupas® Capsule on Cardiovascular System in Patients With Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia
Verified date | March 2018 |
Source | JW Pharmaceutical |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
To evaluate effect on cardiovascular system(blood pressure) when Thrupas® capsule is administered every day for 12 weeks in patients with Lower Urinary Tract Symptoms suggestive of Benign Prostatic Hyperplasia
Status | Completed |
Enrollment | 400 |
Est. completion date | November 2014 |
Est. primary completion date | November 2014 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria: Patients who have been diagnosed with BPH by digital rectal exam or ultrasonographic findings and meet the following criteria. 1. Male, 50 years or older 2. Patients with a total I-PSS score = 8 3. Patients with a QoL score = 3 4. Patients who voluntarily decided to participate and have filled out consent form Exclusion Criteria: 1. Patients with an allergy to a-blockers 2. Patients with history of severe arrhythmia, cardiac failure, cardiac infarction, unstable angina, cerebral infarction within 6 months 3. Patients with severe hepatic disorders (hepatic insufficiency, cirrhosis, jaundice, hepatoma) 4. Patients with renal dysfunction 5. Has PSA value = 10ng/ml or has been diagnosed with tumor by biopsy even if PSA value is lower than 10ng/ml, 6. Patients with history of prostate surgery 7. Patients previously administered with 5a-reductase inhibitor within 3 months 8. Patients previously administered with a1-adrenoceptor antagonist within 1 month 9. Patients who are taking the following drugs at the start of study or those who have to take during the 12 weeks of the study: aß-adrenoceptor antagonist, a-adrenoceptor agonist, anticholinergic (tolterodine, oxybutynin, etc.) 10. Patients with a history of intrapelvic radiation therapy or prostatic hyperthermia |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Hallym University Sacred Heart Hospital | Anyang-si | Gyeonggi-do |
Korea, Republic of | Asan Medical Center | Seoul | |
Korea, Republic of | Gangam Severance Hospital | Seoul | |
Korea, Republic of | Seoul St. Mary's Hospital of the Catholic University of Korea | Seoul |
Lead Sponsor | Collaborator |
---|---|
JW Pharmaceutical |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in blood pressure (systolic, diastolic) before and after administration | 3 months | ||
Secondary | Change in IPSS total score before and after administration* | 3 months | ||
Secondary | Change in QoL score before and after administration | 3 months | ||
Secondary | Change in IPSS subscore before and after administration | 3 months | ||
Secondary | Evaluation of BSW after administration | 3 months | ||
Secondary | Change in Qmax before and after administration | 3 months | ||
Secondary | Adverse events | 3 months |
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