Status:
WITHDRAWN
Sildenafil for Chronic Obstructive Pulmonary Disease (COPD) Associated Pulmonary Hypertension
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Aarhus University Hospital
Conditions:
COPD
Pulmonary Hypertension
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Chronic obstructive pulmonary disease (COPD)can be complicated by an increased pressure in the pulmonary circulation. This worsens the prognosis, but so far it is unknown whether treatment of the incr...
Eligibility Criteria
Inclusion
- A mean pulmonary arterial pressure of 25 mmHg measured by right heart catheterization.
- A diagnosis of COPD-associated pulmonary hypertension, implicating that no other potential cause of pulmonary hypertension is present.
- Stable COPD, defined by no subjective alterations of symptoms or use of short acting beta-antagonists for minimally six weeks. Any exacerbation resulting in admission to hospital or other contacts to a physician must have ceased for at least 6 weeks before entering the study.
- Age \> 18
- Informed written consent.
- Reliable anticonception for fertile women.
Exclusion
- Rheumatic disease limiting walking capacity.
- Exacerbation in COPD during the study.
- Age\>80 years
- FEV1 \< 25 % of predicted.
- Allergy towards contents of sildenafil or placebo tablets.
- Fall in blood pressure of \> 30 mmHg systolic or \>20 mmHg diastolic after intake of the first dose of trial medication.
- Fall in peripheral saturation of \> 5% after intake of the first dose of trial medication.
- Treatment with nitrous vasodilators or aminophyllamines.
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00730067
Start Date
June 1 2012
End Date
December 1 2012
Last Update
August 23 2012
Active Locations (2)
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1
Department of Pulmonary Diseases, Århus Sygehus
Aarhus, Denmark, Dk-8000
2
Department of Cardiology, Skejby sygehus
Århus N, Denmark, DK_8200