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Chapel Hill, North Carolina 27599


Purpose:

This study is designed to assess the efficacy and safety of tadalafil in patients with Sarcoidosis Associated Pulmonary Hypertension. Hypothesis: Tadalafil is safe and effective in treating pulmonary hypertension in patients with Sarcoidosis


Criteria:

Inclusion Criteria: - Biopsy proven sarcoidosis - Mean pulmonary artery pressure > 25 mmHg at rest or greater than 30 mmHg with exercise by right heart catheterization within 1 year prior to entry into study - Pulmonary capillary wedge pressure ≤ 15 mmHg - PVR values ≥ 3.0 Woods units - Forced vital capacity (FVC) > 40% predicted - Forced expiratory volume in 1 second (FEV1) > 40% predicted - WHO functional class II or III - Stable sarcoidosis treatment regimen for three months prior to entry into study - 6 minute walk distance between 150-450 meters - Stable dose of antihypertensive medications - On no other medication to treat PAH (sildenafil, vardenafil, treprostinil, epoprostenol, iloprost, bosentan, ambrisentan) within one month prior to enrollment and during duration of the study - Non-pregnant females Exclusion Criteria: - Exercise limitation related to a non-cardiopulmonary reason (e.g. arthritis) - Severe systemic hypertension > 170/95 - Severe systemic hypotension < 90/50 - History of priapism - Patients with congestive heart failure (left ventricular dysfunction) LVEF < 45% by echocardiogram - Anticipation by the investigator for escalation in sarcoidosis treatment during the course of the study - Pulmonary hypertension related to etiology other than sarcoidosis (i.e. HIV, scleroderma, chronic thromboemboli) - Use within 1 month of an sildenafil or vardenafil - WHO functional class IV status - Patients with severe other organ disease felt by investigators to impact on survival during the course of the study - Subjects with liver function abnormalities (ALT or AST > 3 times the upper limit of normal at screening or at baseline) or chronic liver disease - Advanced kidney failure (GFR < 30 ml/min at screening or at baseline) - History of hypersensitivity reaction or adverse effect related to tadalafil - Pregnant or lactating women - Concomitant use of nitrates (any form) either regularly or intermittently - Concomitant use of potent CYP3A inhibitors (eg, ritonavir, ketoconazole, itraconazole) - Any additional contraindications and precautions specified in the package inserts for Tadalafil (Adcirca) not listed above


NCT ID:

NCT01324999


Primary Contact:

Principal Investigator
Hubert J Ford, M.D.
University of North Carolina, Chapel Hill


Backup Contact:

N/A


Location Contact:

Chapel Hill, North Carolina 27599
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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