Nebivolol Effects on Endothelial Function and Erectile Function
NCT ID: NCT01885988
Last Updated: 2013-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
70 participants
INTERVENTIONAL
2013-03-31
2014-06-30
Brief Summary
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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 initial/final 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Nebivolol
Nebivolol 5, 10 or 20 mg tablet, oral, daily for 3 months. Nebivolol dosage will be titrated per blood pressure results.
Nebivolol
Nebivolol 5, 10 or 20 mg tablet, oral, daily for 3 months. Nebivolol dosage will be titrated per blood pressure results.
Sugar pill
Sugar pill 5, 10 or 20 mg tablet, orally, daily. Sugar pill dosage will be titrated per blood pressure results.
Sugar Pill
Sugar pill 5, 10 or 20mg taken by mouth, daily. Sugar pill dosage will be titrated per blood pressure results.
Interventions
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Nebivolol
Nebivolol 5, 10 or 20 mg tablet, oral, daily for 3 months. Nebivolol dosage will be titrated per blood pressure results.
Sugar Pill
Sugar pill 5, 10 or 20mg taken by mouth, daily. Sugar pill dosage will be titrated per blood pressure results.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male Patients with ED (IIEF-5 ) Score \> 13 and \< 21
o If a subject is using PDE5's( phosphodiesterase type 5 inhibitors), there must be a two week washout of PDE5 use, then in two weeks without PDE5 use; 4 attempts at sexual activity and an IIEF score \< 21 on at least 2 of the four efforts
* Treatment naïve patients with Pre-hypertension (BP 120-139/80-89) or
* Stage 1 hypertension (BP \> 140 but \< 159/ 90-99)
* Patients in a stable, monogamous relationship
* Patients are able to comprehend and satisfactorily comply with protocol requirements
* Eugonadal Men : Total Testosterone 300 ng/dL-1000 ng/dL or greater, as well as men who are eugonadal with treatment.
* Non-smoker
Exclusion Criteria
* Normal RigiScan at Baseline
* Concomitant use of ACE/ ARB (angiotensin receptor blocker)/ Beta-blocking agents/CCB (calcium channel blocker) / alpha-blocker
* Concomitant use of PDE5'S
* Currently Smoking
* Patients who have a medical condition that, in the Investigator's opinion, would expose them to an increased risk of a significant adverse event or interfere with assessments of safety and efficacy during the course of the trial.
* Patients with any current malignancy, or any clinically significant hematological, endocrine, cardiovascular, renal, hepatic, gastrointestinal or neurological disease. If there is a history of such disease but the condition has been stable for at least the past year and is judged by the investigator not to interfere with the patient's participation in the study, the patient may be included.
* Patients who are unable to speak, read, and understand English or are judged by the investigator to be unable or unlikely to follow the study protocol and complete all scheduled visits.
25 Years
65 Years
MALE
No
Sponsors
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Forest Laboratories
INDUSTRY
Martin M. Miner, MD
OTHER
Responsible Party
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Martin M. Miner, MD
Co-Director Men's Health Center
Principal Investigators
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Martin M Miner, MD
Role: PRINCIPAL_INVESTIGATOR
The Miriam Hospital, a Lifespan partner
Locations
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University Medicine
Providence, Rhode Island, United States
Miriam Cardiology
Providence, Rhode Island, United States
The Miriam Hospital / The Men's Health Center
Providence, Rhode Island, United States
Countries
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Central Contacts
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Facility Contacts
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Tony Wu, MD
Role: primary
Other Identifiers
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BYS-IT-74
Identifier Type: -
Identifier Source: org_study_id
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