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Therapeutic Effect of Sildenafil in Patients With Coronary Vasospasm

NCT00454714 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2017-04-12

No results posted yet for this study

Summary

This will be a prospective, phase IIIb, double-blind and randomized trial testing the effect of single dose sildenafil application in patients with coronary vasospasm compared to placebo application.

The target variable to be tested is the degree of coronary vasoconstriction in response to intracoronary ACh application (in addition to clinical chest pain) which will be imaged by coronary angiography and measured using quantitative coronary angiography software.

Main objective: Has sildenafil the potency to inhibit the induction of coronary vasospasm by intracoronary ACh-application in patients with proven coronary artery spasm?

Secondary objective: Which degree of coronary vasospasm inhibition can be achieved with sildenafil?

Conditions

  • Coronary Vasospasm

Interventions

DRUG

single dose Sildenafil

Application of a single dose Sildenafil

DRUG

Single dose placebo

Application of a single dose placebo

Sponsors & Collaborators

  • Udo Sechtem

    lead OTHER

Principal Investigators

  • Udo Sechtem, MD · Robert Bosch-Krankenhaus Stuttgart

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-01
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00454714 on ClinicalTrials.gov