Benign Prostatic HyperplasiaCVNCT02029560
Observational Study to Evaluate Effect of Thrupas® Capsule on Cardiovascular System
An observational study of Benign Prostatic Hyperplasia, run by JW Pharmaceutical at 4 sites in South Korea.
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 Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- How many people
- 400 participants
- Where
- 4 sitesSouth Korea
- Study dates
- Nov 2013to Nov 2014
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: The number of study subjects was calculated based on safety end-point which was variable change in SBP measurement before and after the administration of Silodosin. In previous studies, the standard deviation in before and after administration of Silodosin was 12.81. Therefore, this study assumed the standard deviation in before and after administration to be 12.81. When the significance level was 0.05, the confidence interval was 1.41 and standard deviation of SBP measurement before and after the administration of Silodocsin was 12.81, the standard sample size will be 318 people and target number of study subject will be 400 as the expected drop rate is 20%.
Who may be able to join
- Patients who have been diagnosed with BPH by digital rectal exam or ultrasonographic findings and meet the following criteria.
- Male, 50 years or older
- Patients with a total I-PSS score ≥ 8
- Patients with a QoL score ≥ 3
- Patients who voluntarily decided to participate and have filled out consent form
Who cannot join
- Patients with an allergy to α-blockers
- Patients with history of severe arrhythmia, cardiac failure, cardiac infarction, unstable angina, cerebral infarction within 6 months
- Patients with severe hepatic disorders (hepatic insufficiency, cirrhosis, jaundice, hepatoma)
- Patients with renal dysfunction
- Has PSA value ≥ 10ng/ml or has been diagnosed with tumor by biopsy even if PSA value is lower than 10ng/ml,
- Patients with history of prostate surgery
Show all 10Show fewer
- Patients previously administered with 5α-reductase inhibitor within 3 months
- Patients previously administered with α1-adrenoceptor antagonist within 1 month
- 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: αβ-adrenoceptor antagonist, α-adrenoceptor agonist, anticholinergic (tolterodine, oxybutynin, etc.)
- Patients with a history of intrapelvic radiation therapy or prostatic hyperthermia
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, 431-796
Gangam Severance Hospital
Seoul, 135-720
Seoul St. Mary's Hospital of the Catholic University of Korea
Seoul, 137-701
Asan Medical Center
Seoul, 138-736
About this study
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
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
Read the detailed 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.
- Conditions
- Benign Prostatic Hyperplasia
- Medical subject headings
- Prostatic Hyperplasia
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood pressure (systolic, diastolic) before and after administration
Measured: 3 months
Secondary outcomes (6)
Change in IPSS total score before and after administration*
Measured: 3 months
Change in QoL score before and after administration
Measured: 3 months
Change in IPSS subscore before and after administration
Measured: 3 months
Evaluation of BSW after administration
Measured: 3 months
Change in Qmax before and after administration
Measured: 3 months
Adverse events
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startNov 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02029560
- Sponsor's protocol ID
- JWP-SDS-405
- Acronym
- CV
- Status last verified
- Mar 2018
- First submitted
- 25 Nov 2013
- Last updated
- 8 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02029560
- Acronym / sponsor ID
- CV / JWP-SDS-405
- Conditions
- Benign Prostatic Hyperplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Nov 2013 (actual)
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 8 Jan 2014 (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.
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
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The number of study subjects was calculated based on safety end-point which was variable change in SBP measurement before and after the administration of Silodosin. In previous studies, the standard deviation in before and after administration of Silodosin was 12.81. Therefore, this study assumed the standard deviation in before and after administration to be 12.81. When the significance level was 0.05, the confidence interval was 1.41 and standard deviation of SBP measurement before and after the administration of Silodocsin was 12.81, the standard sample size will be 318 people and target number of study subject will be 400 as the expected drop rate is 20%.
Key inclusion criteria (5 listed)
- Patients who have been diagnosed with BPH by digital rectal exam or ultrasonographic findings and meet the following criteria.
- Male, 50 years or older
- Patients with a total I-PSS score ≥ 8
- Patients with a QoL score ≥ 3
- Patients who voluntarily decided to participate and have filled out consent form
Key exclusion criteria (10 listed)
- Patients with an allergy to α-blockers
- Patients with history of severe arrhythmia, cardiac failure, cardiac infarction, unstable angina, cerebral infarction within 6 months
- Patients with severe hepatic disorders (hepatic insufficiency, cirrhosis, jaundice, hepatoma)
- Patients with renal dysfunction
- Has PSA value ≥ 10ng/ml or has been diagnosed with tumor by biopsy even if PSA value is lower than 10ng/ml,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in blood pressure (systolic, diastolic) before and after administration
Time frame: 3 months
6 secondary outcomes
Change in IPSS total score before and after administration*
Time frame: 3 months
Change in QoL score before and after administration
Time frame: 3 months
Change in IPSS subscore before and after administration
Time frame: 3 months
Evaluation of BSW after administration
Time frame: 3 months
Change in Qmax before and after administration
Time frame: 3 months
Adverse events
Time frame: 3 months
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 8 Mar 2018.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Prostatic Hyperplasia, run by JW Pharmaceutical at 4 sites in South Korea.
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: finished, as of the sponsor's last update on 8 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. 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.
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?
Change in blood pressure (systolic, diastolic) before and after administration (time frame: 3 months). 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 8 Mar 2018.