Tadalafil for Sarcoidosis Associated Pulmonary Hypertension

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01324999
• Date of registration: 24/03/2011
• Prospective Registration: No
• Primary sponsor: University of North Carolina, Chapel Hill
• Public title: Tadalafil for Sarcoidosis Associated Pulmonary Hypertension SAPH
• Scientific title: Tadalafil for Sarcoidosis Associated Pulmonary Hypertension
• Date of first enrolment: March 2011
• Target sample size: 12
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01324999
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2/Phase 3

Countries of recruitment

United States

Contacts

• Name: Hubert J Ford, M.D.
• Affiliation: University of North Carolina, Chapel Hill

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Hypertension

Intervention(s)

Drug: Tadalafil

Primary Outcome(s)

6 Minute Walk Distance [Time Frame: Baseline, Week 8, Week 16, Week 24]

Secondary Outcome(s)

Number of Participants With Change in WHO Functional Class (WHO FC) [Time Frame: Baseline, Week 24]

Resting Oxygen Saturation [Time Frame: Baseline, Week 24]

Oxygen Desaturation During 6 Minute Walk Test [Time Frame: Baseline, Week 24]

Maximum Borg Dyspnea Score During 6 Minute Walk Test [Time Frame: Baseline, Week 8, Week 16, Week 24]

Short Form-36 Global Score [Time Frame: Baseline, Week 8, Week 16, Week 24]

Brain Natriuretic Peptide Level [Time Frame: Baseline, Week 8, Week 16, Week 24]

St. George's Respiratory Questionnaire (SGRQ) Score [Time Frame: Baseline, Week 8, Week 16, Week 24]

Secondary ID(s)

09-2326

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Eli Lilly and Company

United Therapeutics

University of Cincinnati

Results

• Results available: Yes
• Date Posted: 24/07/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01324999