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Tadalafil for Sarcoidosis Associated Pulmonary Hypertension (SAPH)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01324999
First Posted: March 29, 2011
Last Update Posted: July 24, 2017
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.
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
Results First Submitted: March 21, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Pulmonary Hypertension
Intervention: Drug: Tadalafil

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Tadalafil 40 mg daily

Participant Flow:   Overall Study
    Tadalafil
STARTED   12 
COMPLETED   7 
NOT COMPLETED   5 
Adverse Event                3 
Withdrawal by Subject                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Tadalafil 40 mg daily

Baseline Measures
   Tadalafil 
Overall Participants Analyzed 
[Units: Participants]
 12 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.5  (9.48) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      8  66.7% 
Male      4  33.3% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
 
Black or African American   9 
White   3 
Region of Enrollment 
[Units: Participants]
 
United States   12 
FEV1 
[Units: Percent predicted]
Mean (Standard Deviation)
 58.0  (14.7) 
FVC 
[Units: Percent predicted]
Mean (Standard Deviation)
 65.9  (13.4) 
DLCO 
[Units: Percent predicted]
Mean (Standard Deviation)
 60.3  (25.0) 
Right Atrial Pressure 
[Units: Mm Hg]
Mean (Standard Deviation)
 6.2  (4.0) 
Mean Pulmonary Artery Pressure 
[Units: Mm Hg]
Mean (Standard Deviation)
 34.8  (7.1) 
Pulmonary Artery Wedge Pressure 
[Units: Mm Hg]
Mean (Standard Deviation)
 10.3  (3.6) 
Cardiac Index 
[Units: L/min/m²]
Mean (Standard Deviation)
 2.4  (0.6) 
Pulmonary Vascular Resistance 
[Units: Wood Units]
Mean (Standard Deviation)
 6.2  (3.6) 


  Outcome Measures
  Show All Outcome Measures

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

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

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

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

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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Since this was a proof of concept study evaluating safety and tolerability of the intervention in this population, it was not powered to achieve statistical significance in changes observed from baseline to week 24 in any of the endpoints.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: H. James Ford, MD
Organization: University of North Carolina at Chapel Hill
phone: (919) 966-2531
e-mail: hjford@med.unc.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: H. James Ford, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01324999     History of Changes
Other Study ID Numbers: 09-2326
First Submitted: March 24, 2011
First Posted: March 29, 2011
Results First Submitted: March 21, 2017
Results First Posted: July 24, 2017
Last Update Posted: July 24, 2017