Observational Study to Evaluate Effect of Thrupas® Capsule on Cardiovascular System

Benign Prostatic Hyperplasia Clinical Trial

— CV  

Official title:

Observational Study to Evaluate Effect of Thrupas® Capsule on Cardiovascular System in Patients With Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02029560
• Other study ID #: JWP-SDS-405
• Status: Completed
• Phase: N/A
• First received: November 25, 2013
• Last updated: March 6, 2018
• Start date: November 2013
• Est. completion date: November 2014

Study information

• Verified date: March 2018
• Source: JW Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Description:

BPH and hypertension are chronic senile diseases that increase in prevalence with age. It is reported that 25% of men over 60 years old suffer from both BPH and hypertension. Though these two diseases differ in nature, there is a hypothesis advanced from recent studies that for both diseases, increase in sympathetic tone plays an important role in pathophysiology.

As a medical treatment of BPH, α-blockers are widely selected in clinical studies as a first line treatment in patients with LUTS, for its non-invasiveness and superior clinical efficacy [1, 5]. Such α-blockers increases urine flow and decreases residual urine by controlling excitement of the sympathetic nervous system distributed around smooth muscle of prostate and bladder neck. Through this, α-blockers improve conditions of clinical symptoms of patients suffering from LUTS due to BPH, and decrease need for invasive surgery related to BPH, and also have medical action to decrease morbidity rate of secondary complications of BPH such as acute retention of urine, deterioration of renal function, bladder stone and urinary tract infection.

However, in the case of patients who are on hypertension medication, when considering concomitant administration with α-blockers, adverse events such as orthostatic hypotension and dizziness due to drop in blood pressure is most concerned. In this regard, silodosin, as an alpha 1A adrenoceptor antagonist, has been proven have low occurrence of adverse events related to cardiovascular system and have little effect on blood pressure compared to other α-blockers.

Thus, in this study, we aim to see the effect on cardiovascular system(blood pressure) Thrupas® capsule is administered every day for 12 weeks in patients with LUTS suggestive of BPH.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Lower Urinary Tract Symptoms
• Prostatic Hyperplasia

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
JW Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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