Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00479908
Status:
COMPLETED
Last Update Posted:
2007-05-30
First Post:
2007-05-29
Brief Title:
Blood Pressure Interaction Between Sildenafil and Sublingual Glyceryl Trinitrate GTN in Men With Angina
Sponsor:
University of Edinburgh
Organization:
University of Edinburgh
Study Overview
Official Title:
Investigation of the Time Course of the Interaction of the Hypotensive Effects of Sildenafil Citrate and Sublingual Glyceryl Trinitrate GTN in Men With Stable Angina Pectoris
Status:
COMPLETED
Status Verified Date:
2007-05
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 determine for how long sildenafil potentiates the blood pressure reduction that occurs with glyceryl trinitrate in men with angina
Detailed Description:
By producing a mediator known as cGMP nitric oxide NO potently dilates blood vessels Nitrates such as glyceryl trinitrate GTN are drugs that release NO NO donors and are widely used in the treatment and prevention of angina Sildenafil is an effective treatment for male penile erectile dysfunction that inhibits the breakdown cGMP When given alone it causes modest reductions in BP in healthy people and patients with cardiovascular disease By their synergistic actions co-administration of NO donors with sildenafil can result in large reductions in BP in patients with angina a population at increased risk of developing erectile dysfunction As a result it is recommended that the two drugs not be co-administered within 24 hours of one another
Previous studies have defined the effect of nitrates at 60 min after administration of sildenafil the time of likely maximum interaction However emergency medicine physicians would value evidence of a balance of risks from which to make a personal clinical judgement about when they might consider giving GTN in a patient presenting with a severe episode of angina who has recently received sildenafil Evidence on which to base such a judgement is currently not available However we have recently completed a study showing that the interaction of GTN 04 mg spray after sildenafil 100 mg lasts less than 4 hours in healthy subjects Whilst the findings would probably be similar for patients with angina this question now needs to be investigated directly in order to ensure the generalisability of this work and address an important unresolved clinical issue
Subjects will be asked to refrain from using short-acting nitrates for 24 hours and long acting nitrates for 72 hours before the start of the study On the morning of each study visit subjects will take their normal medications including anti-anginals as soon as they wake up at home They will also eat a light breakfast at home before coming to the research unit
Subjects will attend 4 study visits each separated by at least 5 days At study visit 1 GTN will be administered 4 and 8 hours after oral sildenafil or matched placebo At visit 2 GTN will be administered 4 and 8 hours after the alternative treatment sildenafil or placebo The order in which sildenafil and placebo are given will be randomised At study visit 3 GTN will be administered 1 and 6 hours after sildenafil or placebo Finally at visit 4 GTN will be administered 1 and 6 hours after the alternative treatment sildenafil or placebo As with visits 1 and 2 the order in which sildenafil and placebo are given will be randomised
Regular single measures of sitting and standing after 2 min standing BP and heart rate HR will be recorded at baseline and before and for 40 minutes after each GTN administration Venous blood samples 20 mL will be taken at baseline and immediately before and 40 min after each GTN administration for later determination of plasma concentrations of sildenafil and its active metabolite UK-103320
Previous studies have defined the effect of nitrates at 60 min after administration of sildenafil the time of likely maximum interaction However emergency medicine physicians would value evidence of a balance of risks from which to make a personal clinical judgement about when they might consider giving GTN in a patient presenting with a severe episode of angina who has recently received sildenafil Evidence on which to base such a judgement is currently not available However we have recently completed a study showing that the interaction of GTN 04 mg spray after sildenafil 100 mg lasts less than 4 hours in healthy subjects Whilst the findings would probably be similar for patients with angina this question now needs to be investigated directly in order to ensure the generalisability of this work and address an important unresolved clinical issue
Subjects will be asked to refrain from using short-acting nitrates for 24 hours and long acting nitrates for 72 hours before the start of the study On the morning of each study visit subjects will take their normal medications including anti-anginals as soon as they wake up at home They will also eat a light breakfast at home before coming to the research unit
Subjects will attend 4 study visits each separated by at least 5 days At study visit 1 GTN will be administered 4 and 8 hours after oral sildenafil or matched placebo At visit 2 GTN will be administered 4 and 8 hours after the alternative treatment sildenafil or placebo The order in which sildenafil and placebo are given will be randomised At study visit 3 GTN will be administered 1 and 6 hours after sildenafil or placebo Finally at visit 4 GTN will be administered 1 and 6 hours after the alternative treatment sildenafil or placebo As with visits 1 and 2 the order in which sildenafil and placebo are given will be randomised
Regular single measures of sitting and standing after 2 min standing BP and heart rate HR will be recorded at baseline and before and for 40 minutes after each GTN administration Venous blood samples 20 mL will be taken at baseline and immediately before and 40 min after each GTN administration for later determination of plasma concentrations of sildenafil and its active metabolite UK-103320
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