Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:41 AM
Ignite Modification Date:
2025-12-25 @ 12:41 AM
NCT ID:
NCT00730067
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00730067
Study Brief:
Protocol Section:
NCT00730067