Tadalafil for Sarcoidosis Associated Pulmonary Hypertension (SAPH)
This study is currently recruiting participants.
Verified April 2013 by University of North Carolina, Chapel Hill
Sponsor:
University of North Carolina, Chapel Hill
Collaborators:
Eli Lilly and Company
United Therapeutics
Information provided by (Responsible Party):
Hubert M. Ford, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01324999
First received: March 24, 2011
Last updated: April 9, 2013
Last verified: April 2013
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Hypertension |
Drug: Tadalafil |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Tadalafil for Sarcoidosis Associated Pulmonary Hypertension |
Resource links provided by NLM:
Further study details as provided by University of North Carolina, Chapel Hill:
Primary Outcome Measures:
- Change in 6 minute walk distance [ Time Frame: 5 months of therapy ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | March 2011 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Sarcoidosis Associated Pulmonary Hypertension
Sarcoidosis Associated Pulmonary Hypertension
|
Drug: Tadalafil
20mg/day for one month then 40mg/day for additional 4 months
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01324999
Contacts
| Contact: Hubert J Ford, MD | 919-966-2531 | hjford@med.unc.edu |
| Contact: Sharikia J Burt, MS | 919-966-2531 | sburt99@med.unc.edu |
Locations
| United States, North Carolina | |
| University of North Carolina at Chapel Hill | Recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
| Principal Investigator: Hubert J Ford, MD | |
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Eli Lilly and Company
United Therapeutics
Investigators
| Principal Investigator: | Hubert J Ford, M.D. | University of North Carolina, Chapel Hill |
More Information
No publications provided
| Responsible Party: | Hubert M. Ford, MD, Assistant Professor of Medicine, University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT01324999 History of Changes |
| Other Study ID Numbers: | 09-2326 |
| Study First Received: | March 24, 2011 |
| Last Updated: | April 9, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of North Carolina, Chapel Hill:
|
Sarcoidosis Associated Pulmonary Hypertension |
Additional relevant MeSH terms:
|
Hypertension, Pulmonary Hypertension Sarcoidosis Vascular Diseases Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases Lymphoproliferative Disorders Lymphatic Diseases |
Tadalafil Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Vasodilator Agents Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 13, 2013