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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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13 October 2020 |
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Main ID: |
EUCTR2006-004705-26-GB |
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Date of registration:
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17/04/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Safety and Tolerability of Sildenafil in Patients with Eisenmenger Physiology
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Scientific title:
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Safety and Tolerability of Sildenafil in Patients with Eisenmenger Physiology |
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Date of first enrolment:
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10/05/2007 |
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Target sample size:
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12 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-004705-26 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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United Kingdom
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Key inclusion & exclusion criteria
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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
F.1.3.1 Number of subjects for this age range
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.
10. Patients taking phosphodiesterase inhibitors, nitrates or endothelin receptor antagonists
11. Patients with planned surgical intervention during the study period.
15. Pregnant patients
16. Patients treated with potent CYP3A4 inhibitors
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Eisenmenger Syndrome (pulmonary hypertension due to congenital heart disease)
MedDRA version: 8.1
Level: LLT
Classification code 10058554
Term: Eisenmenger's syndrome
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Intervention(s)
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Trade Name: Revatio ® 20 mg film-coated tablets
Product Name: Sildenafil
Pharmaceutical Form: Tablet
INN or Proposed INN: Sildenafil (REVATIO)
CAS Number: 139755832
Current Sponsor code: cro529
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
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Primary Outcome(s)
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Main Objective: To examine safety and tolerability of oral sildenafil in patients with Eisenmenger physiology.
Primary endpoint:
Effects of sildenafil on systemic oxygen saturation in patients with pulmonary arterial hypertension related to Eisenmenger physiology
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Primary end point(s): Effects of sildenafil on systemic oxygen saturation (%) in patients with pulmonary arterial hypertension related to Eisenmenger physiology.
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Secondary Objective: To evaluate the effects of sildenafil on
- WHO functional class
- 6 minute walk test
- Dyspnea (Borg Index)
- Pulmonary perfusion (using respiratory mass spectrometry)
- Quality of life
- Overall safety and tolerability
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 21/12/2006
Contact:
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