NCT00479908

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 29, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 30, 2007

Completed
Last Updated

May 30, 2007

Status Verified

May 1, 2007

First QC Date

May 29, 2007

Last Update Submit

May 29, 2007

Conditions

Angina Pectoris

Keywords

Blood pressureAnginaSildenafilPhosphodiesterase type 5Organic nitrateGlyceryl trinitrateDrug interaction

Outcome Measures

Primary Outcomes (1)

  • Effect of combined sildenafil and GTN on mean maximum reduction in blood pressure

Interventions

Sildenafil citrateDRUG
Glyceryl trinitrateDRUG

Eligibility Criteria

Age30 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male
  • Stable angina with one of:
  • Classical history of exertional angina pectoris
  • Previous diagnostic exercise test
  • Angiographic evidence of CAD
  • Aged 30 to 80 years
  • Weight between 60 and 100 Kg

You may not qualify if:

  • Regular treatment with long-acting nitrates or nicorandil where these cannot be withdrawn 72 hours prior to the study
  • Myocardial infarction, unstable angina, stroke or transient cerebral ischaemia within 3 months
  • Systolic BP \> 170 mmHg or diastolic BP \> 100 mmHg
  • Systolic BP \< 100 mmHg or diastolic BP \< 60 mmHg
  • Orthostatic hypotension (\> 20 mmHg fall in systolic BP on standing)
  • Diabetes treated with oral hypoglycaemic agents or insulin
  • Any clinically significant disease other than stable angina, excepting other cardiovascular disease risk factors, e.g. smoking, hypercholesterolaemia and diet-controlled diabetes
  • Taking any drug that interacts with sildenafil
  • Evidence of drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Edinburgh

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

MeSH Terms

Conditions

Angina Pectoris

Interventions

Sildenafil CitrateNitroglycerin

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingNitro Compounds

Study Officials

  • James J Oliver, MBChB

    University of Edinburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 29, 2007

First Posted

May 30, 2007

Study Start

January 1, 2004

Study Completion

September 1, 2005

Last Updated

May 30, 2007

Record last verified: 2007-05

Locations

GB(1)