Ignite Creation Date:
2024-05-06 @ 1:44 AM
Last Modification Date:
2024-10-26 @ 11:09 AM
Study NCT ID:
NCT01885988
Status:
UNKNOWN
Last Update Posted:
2013-06-25
First Post:
2013-06-14
Brief Title:
Nebivolol Effects on Endothelial Function and Erectile Function
Sponsor:
Martin M Miner MD
Organization:
The Miriam Hospital
Study Overview
Official Title:
Nebivolol Effects on Endothelial Function and Erectile Function in Non-smoking Pre-hypertensive and Newly Diagnosed Stage 1 Hypertensive Men With Erectile Dysfunction
Status:
UNKNOWN
Status Verified Date:
2013-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NEB-ED
Brief Summary:
The study will take part at The Mens Health Center It will involve men who have a diagnosis of erectile dysfunction and also have high blood pressure
High blood pressure can affect the lining of the arteries and cause stiffness in the arteries The arteries and veins throughout the body have a lining called the endothelium which gives them the ability to stretch If the lining of the penile arteries becomes impaired it can decrease the stretching of the artery and decrease blood flow Decreased blood flow in the penile arteries can cause problems obtaining an erection
The study medication Nebivolol controls blood pressure by relaxing smooth muscle around the lining of the arteries thereby improving stretch and blood flow
The primary objective is to determine if treatment with nebivolol improves endothelial function and erectile function in men with pre-hypertension and stage 1 hypertension
70 men will be enrolled into the study Half of the subjects will receive active medication and half will receive a placebo All men will receive educational informational handouts about blood pressure and behavior modifications to improve blood pressure The study will last for 3 months for each subject The expected recruitment time is one year with a 2 year study completion goal Subjects will have approximately 5 study visits
Subjects will have initialfinal blood work a Rigiscan test a take home penile erection test two EndoPat tests to assess endothelium function 3 SphygmoCor tests to assess central blood pressure 2 sexual health questionnaires at 2 visits Vital signs will be monitored at each visit to assess safety and effectiveness of the study medication
High blood pressure can affect the lining of the arteries and cause stiffness in the arteries The arteries and veins throughout the body have a lining called the endothelium which gives them the ability to stretch If the lining of the penile arteries becomes impaired it can decrease the stretching of the artery and decrease blood flow Decreased blood flow in the penile arteries can cause problems obtaining an erection
The study medication Nebivolol controls blood pressure by relaxing smooth muscle around the lining of the arteries thereby improving stretch and blood flow
The primary objective is to determine if treatment with nebivolol improves endothelial function and erectile function in men with pre-hypertension and stage 1 hypertension
70 men will be enrolled into the study Half of the subjects will receive active medication and half will receive a placebo All men will receive educational informational handouts about blood pressure and behavior modifications to improve blood pressure The study will last for 3 months for each subject The expected recruitment time is one year with a 2 year study completion goal Subjects will have approximately 5 study visits
Subjects will have initialfinal blood work a Rigiscan test a take home penile erection test two EndoPat tests to assess endothelium function 3 SphygmoCor tests to assess central blood pressure 2 sexual health questionnaires at 2 visits Vital signs will be monitored at each visit to assess safety and effectiveness of the study medication
Detailed Description:
Randomized double-blind placebo-controlled study of 70 non-smoking pre-hypertensive men BP 120-139 80-89 or with newly diagnosed stage 1 hypertension BP 140 but 159 90-99 with erectile dysfunction receiving nebivolol 5-20mg or placebo along with lifestyle modifications daily for 3 months to titrate BP to 12080 or less
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None