Tadalafil for Sarcoidosis Associated Pulmonary Hypertension

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Eli Lilly and Company; United Therapeutics; University of Cincinnati
• Treatments: Tadalafil

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