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Clinical Trials/EUCTR2006-004705-26-GB
EUCTR2006-004705-26-GB
Active, not recruiting
Phase 1

Safety and Tolerability of Sildenafil in Patients with Eisenmenger Physiology

Imperial College London0 sites12 target enrollmentApril 17, 2007
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ConditionsEisenmenger Syndrome (pulmonary hypertension due to congenital heart disease)MedDRA version: 8.1Level: LLTClassification code 10058554Term: Eisenmenger's syndrome
DrugsRevatio ® 20 mg film-coated tablets

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Eisenmenger Syndrome (pulmonary hypertension due to congenital heart disease)
Sponsor
Imperial College London
Enrollment
12
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 17, 2007
End Date
February 27, 2009
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Patients \>18 years with a functional class III (1998 WHO classification).
  • •2\. Patients with pulmonary arterial hypertension related to Eisenmenger physiology
  • •3\. Patients with documented oxygen saturation \<90%, and \>70% (at rest, with room air).
  • •4\. Patients stable for at least 3 months prior to screening.
  • •5\. Patients providing written informed consent.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) no

Exclusion Criteria

  • •1\. Patients with left ventricular dysfunction (ejection fraction \<40%).
  • •2\. Patients with systolic blood pressure \< 85 mm Hg.
  • •3\. Patients with other conditions that may affect the ability to perform a 6\-minute walk test.
  • •4\. Patients unable to provide informed consent and comply with the patient protocol.
  • •5\. Patients with known coronary arterial disease.
  • •6\. Patients with serum creatinine \>125 µM/l.
  • •6\. Patients with hemoglobin or hematocrit that is more than 30% below the normal range (patients with secondary polycythemia are permitted).
  • •7\. Patients who have started or stopped treatment for PAH within one month of screening, excluding anticoagulation.
  • •8\. Patients who are receiving vasodilators including, but not limited to epoprostenol or prostacyclin analogues, or are expected to receive any of these drugs during the study.
  • •9\. Patients active on organ transplant lists.

Outcomes

Primary Outcomes

Not specified

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