Phase 3
Completed N=12
Tadalafil for Sarcoidosis Associated Pulmonary Hypertension
Source: ClinicalTrials.gov NCT01324999 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcomePrimary: 6 Minute Walk Distance — 419.1; 418.1; 436.5; 377.1 meters — p=0.68
◆ Published Evidence
Established
42citations · ~4 / year
Tadalafil therapy for sarcoidosis-associated pulmonary hypertension.
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
Linked Publications
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Tadalafil therapy for sarcoidosis-associated pulmonary hypertension.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 6 Minute Walk Distance |
419.1; 418.1; 436.5; 377.1 | 0.68 |
| SECONDARY Resting Oxygen Saturation |
96.5; 95.2 | 0.34 |
| SECONDARY Oxygen Desaturation During 6 Minute Walk Test |
9; 9 | 0.99 |
| SECONDARY Maximum Borg Dyspnea Score During 6 Minute Walk Test |
4.8; 5.0; 5.3; 6.3 | 0.19 |
| SECONDARY Brain Natriuretic Peptide Level |
58.8; 32.3; 37.5; 42.6 | 0.68 |
| SECONDARY Short Form-36 Global Score |
38.5; 37.7; 39.2; 38.9 | 0.92 |
| SECONDARY St. George's Respiratory Questionnaire (SGRQ) Score |
64.5; 65.1; 64.3; 71.1 | 0.44 |
| SECONDARY Number of Participants With Change in WHO Functional Class (WHO FC) |
1; 0; 0 | — |
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT01324999) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.