Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00317421
Status:
COMPLETED
Last Update Posted:
2006-04-24
First Post:
2006-04-20
Brief Title:
Effect of Regular Sildenafil on Blood Pressure and Arterial Function in Hypertension
Sponsor:
University of Edinburgh
Organization:
University of Edinburgh
Study Overview
Official Title:
Effects of Regular Treatment With Sildenafil on Blood Pressure and Endothelial Function in Untreated Hypertensives
Status:
COMPLETED
Status Verified Date:
2004-02
Last Known Status:
None
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:
None
Brief Summary:
The purpose of the study is to investigate if regular treatment with sildenafil reduces blood pressure and improves blood vessel function in patients with hypertension high blood pressure
Detailed Description:
Inhibitors of phosphodiesterase type 5 PDE5 such as sildenafil relax blood vessels In the penis this facilitates erection and sildenafil has proved a very effective treatment for male erectile dysfunction
To date most work on the effects of sildenafil on blood pressure have mainly been investigated in single dose studies These have shown that sildenafil causes a modest reduction in blood pressure even when taken with other blood pressure-lowering drugs providing reassurance on safety when taken as a single dose for erectile dysfunction However these studies do not offer any insight into the potential of PDE5 inhibition in the long-term treatment of hypertension We will address this question by investigating the effects of regular administration of sildenafil on blood pressure It may also be postulated that because of its mechanism of action sildenafil will also improve the function of the endothelium the single layer of cells that lines all blood vessels Therefore the effect of regular sildenafil on endothelial function in hypertension will also be investigated in the study
The study will be performed in a randomised placebo-controlled double blind 2-way crossover manner Sildenafil and matched placebo will each will taken three times daily for 2 weeks with a washout of at least 6 days between treatments Measurements will be made acutely before and 1 hour after oral sildenafil of heart rate blood pressure pulse wave analysis a measure of wave reflection in arteries pulse wave velocity a measure of arterial stiffness and flow-mediated dilatation a measure of endothelial function These measurements will be repeated 2 weeks later again just before and 1 hour after oral sildenafil In addition ambulatory blood pressure will be recorded after 2 weeks of treatment baseline ambulatory BP will be taken as the recording made at diagnosis
To date most work on the effects of sildenafil on blood pressure have mainly been investigated in single dose studies These have shown that sildenafil causes a modest reduction in blood pressure even when taken with other blood pressure-lowering drugs providing reassurance on safety when taken as a single dose for erectile dysfunction However these studies do not offer any insight into the potential of PDE5 inhibition in the long-term treatment of hypertension We will address this question by investigating the effects of regular administration of sildenafil on blood pressure It may also be postulated that because of its mechanism of action sildenafil will also improve the function of the endothelium the single layer of cells that lines all blood vessels Therefore the effect of regular sildenafil on endothelial function in hypertension will also be investigated in the study
The study will be performed in a randomised placebo-controlled double blind 2-way crossover manner Sildenafil and matched placebo will each will taken three times daily for 2 weeks with a washout of at least 6 days between treatments Measurements will be made acutely before and 1 hour after oral sildenafil of heart rate blood pressure pulse wave analysis a measure of wave reflection in arteries pulse wave velocity a measure of arterial stiffness and flow-mediated dilatation a measure of endothelial function These measurements will be repeated 2 weeks later again just before and 1 hour after oral sildenafil In addition ambulatory blood pressure will be recorded after 2 weeks of treatment baseline ambulatory BP will be taken as the recording made at diagnosis
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