Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Tadalafil for Sarcoidosis Associated Pulmonary Hypertension (SAPH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01324999
Recruitment Status : Completed
First Posted : March 29, 2011
Results First Posted : July 24, 2017
Last Update Posted : July 24, 2017
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

Tracking Information
First Submitted Date  ICMJE March 24, 2011
First Posted Date  ICMJE March 29, 2011
Results First Submitted Date  ICMJE March 21, 2017
Results First Posted Date  ICMJE July 24, 2017
Last Update Posted Date July 24, 2017
Study Start Date  ICMJE March 2011
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2017)
6 Minute Walk Distance [ Time Frame: Baseline, Week 8, Week 16, Week 24 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 28, 2011)
Change in 6 minute walk distance [ Time Frame: 5 months of therapy ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2017)
  • Resting Oxygen Saturation [ Time Frame: Baseline, Week 24 ]
    Percent oxygen saturation of hemoglobin as measured by pulse oximetry in the resting state.
  • Oxygen Desaturation During 6 Minute Walk Test [ Time Frame: Baseline, Week 24 ]
    Change (decrease) in oxygen saturation from start of 6 minute walk to nadir during the 6 minute walk test
  • Maximum Borg Dyspnea Score During 6 Minute Walk Test [ Time Frame: Baseline, Week 8, Week 16, Week 24 ]
    The modified Borg scale consists of a vertical scale labelled 0 to10 with corresponding verbal expressions of progressively increasing sensation (shortness of breath) intensity. 0 represents no dyspnea, and 10 is the highest level of perceived dyspnea.
  • Brain Natriuretic Peptide Level [ Time Frame: Baseline, Week 8, Week 16, Week 24 ]
  • Short Form-36 Global Score [ Time Frame: Baseline, Week 8, Week 16, Week 24 ]
    SF- 36 investigates the standard of quality of life through a general health assessment and not specific to a particular disease, age or treatment group. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. The global score is determined by taking an average of the individual domain scores. The global score range is from 0 (worst) to 100 (best).
  • St. George's Respiratory Questionnaire (SGRQ) Score [ Time Frame: Baseline, Week 8, Week 16, Week 24 ]
    The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life)
  • Number of Participants With Change in WHO Functional Class (WHO FC) [ Time Frame: Baseline, Week 24 ]
    The WHO functional classification ranges from I (patient's disease does not affect daily activities) to IV (patient's disease causes severe impairment). Higher scores indicate more severe impairment.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tadalafil for Sarcoidosis Associated Pulmonary Hypertension
Official Title  ICMJE Tadalafil for Sarcoidosis Associated Pulmonary Hypertension
Brief 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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Hypertension
Intervention  ICMJE Drug: Tadalafil
20mg/day for one month then 40mg/day for additional 4 months
Study Arms  ICMJE Experimental: Sarcoid Associated Pulm. Hypertension
Single-arm open-label proof of concept study of tadalafil in patients with sarcoidosis associated pulmonary hypertension.
Intervention: Drug: Tadalafil
Publications * Ford HJ, Baughman RP, Aris R, Engel P, Donohue JF. Tadalafil therapy for sarcoidosis-associated pulmonary hypertension. Pulm Circ. 2016 Dec;6(4):557-562. doi: 10.1086/688775.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 25, 2017)
12
Original Estimated Enrollment  ICMJE
 (submitted: March 28, 2011)
20
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01324999
Other Study ID Numbers  ICMJE 09-2326
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party H. James Ford, MD, University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE
  • Eli Lilly and Company
  • United Therapeutics
  • University of Cincinnati
Investigators  ICMJE
Principal Investigator: Hubert J Ford, M.D. University of North Carolina, Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date June 2017

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