Tadalafil for Sarcoidosis Associated Pulmonary Hypertension (SAPH)

This study has been completed.
Sponsor:
Collaborators:
Eli Lilly and Company
United Therapeutics
University of Cincinnati
Information provided by (Responsible Party):
H. James Ford, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01324999
First received: March 24, 2011
Last updated: April 29, 2014
Last verified: April 2014

March 24, 2011
April 29, 2014
March 2011
July 2013   (final data collection date for primary outcome measure)
Change in 6 minute walk distance [ Time Frame: 5 months of therapy ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01324999 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Tadalafil for Sarcoidosis Associated Pulmonary Hypertension
Tadalafil for Sarcoidosis Associated Pulmonary Hypertension

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

Not Provided
Interventional
Phase 2
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Pulmonary Hypertension
Drug: Tadalafil
20mg/day for one month then 40mg/day for additional 4 months
Experimental: Sarcoidosis Associated Pulmonary Hypertension
Sarcoidosis Associated Pulmonary Hypertension
Intervention: Drug: Tadalafil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
October 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01324999
09-2326
Yes
H. James Ford, MD, University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
  • Eli Lilly and Company
  • United Therapeutics
  • University of Cincinnati
Principal Investigator: Hubert J Ford, M.D. University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP