Tadalafil for Sarcoidosis Associated Pulmonary Hypertension

Completed · Phase 2/Phase 3

Conditions studied: Pulmonary Hypertension

In brief

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 with Sarcoidosis

Key facts

Study ID

NCT01324999

Run by

University of North Carolina, Chapel Hill

People needed

12

Starts

2011-03-01

Expected to finish

2013-10-01

Last updated by the study team

2017-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• University of Cincinnati — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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