Tadalafil for Sarcoidosis Associated Pulmonary Hypertension

Pulmonary Hypertension Clinical Trial

— SAPH  

Official title:

Tadalafil for Sarcoidosis Associated Pulmonary Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01324999
• Other study ID #: 09-2326
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 24, 2011
• Last updated: April 29, 2014
• Start date: March 2011
• Est. completion date: October 2013

Study information

• Verified date: April 2014
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: October 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension
• Sarcoidosis

Intervention

Drug:
• Tadalafil
20mg/day for one month then 40mg/day for additional 4 months

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (4)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Eli Lilly and Company, United Therapeutics, University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 6 minute walk distance		5 months of therapy	No