This study is designed to assess safety and efficacy of tadalafil in patients with
Sarcoidosis Associated Pulmonary Hypertension.
Hypothesis: Tadalafil is safe and effective in treating pulmonary hypertension in patients
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Locations near you
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Full eligibility criteria for NCT01324999
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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
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
All locations for NCT01324999
United States (2)
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Trial results for NCT01324999
Participant Flow: Overall Study
7 / 12
Completed / Started
Serious Adverse Events
0 / 24
Affected / At Risk
Other Adverse Events
5 / 12
Affected / At Risk
View full eligibility
Tris trial is registered with FDA with number: NCT01324999. The sponsor of the trial is University of North Carolina, Chapel Hill and it is looking for 12 volunteers for the current phase.
Official trial title: Tadalafil for Sarcoidosis Associated Pulmonary Hypertension
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