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Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Fibrosis And Treatment With Sildenafil

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by University of California, Los Angeles.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Pfizer
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00625079
First received: February 19, 2008
Last updated: NA
Last verified: February 2008
History: No changes posted

February 19, 2008
February 19, 2008
February 2007
June 2009   (final data collection date for primary outcome measure)
6 minute walk distance [ Time Frame: monthly until date of lung transplantation ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Right heart catheterization hemodynamics [ Time Frame: initial right heart catheterization compared to catheterization done on day of lung transplantation ] [ Designated as safety issue: No ]
  • chemokine analysis on peripheral blood [ Time Frame: monthly ] [ Designated as safety issue: No ]
  • quality of life assessment [ Time Frame: monthly ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Fibrosis And Treatment With Sildenafil
Randomized Placebo-Controlled Study of Sildenafil For The Treatment of Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Fibrosis: A Pilot Study

Pulmonary Arterial Hypertension (PAH) in the setting of Idiopathic Pulmonary Fibrosis(IPF)is a risk factor for morbidity and mortality in the peri-lung transplant(LT) setting. Currently there is no significant data to support the use of pulmonary vasodilators for PAH in the setting of interstitial lung disease such as IPF. The majority of IPF patients have PAH either at rest or during exercise. The study hypothesis is that sildenafil may improve morbidity and mortality in the peri-LT setting in both IPF cohorts with either resting or exercise PAH.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Pulmonary Arterial Hypertension
  • Idiopathic Pulmonary Fibrosis
  • Interstitial Lung Disease
  • Pulmonary Hypertension
  • Drug: sildenafil
    sildenafil 20mg three times per day (orally)
    Other Name: Revatio
  • Drug: sildenafil
    sildenafil (placebo) 20mg three times per day (orally)
  • Placebo Comparator: 1
    There are two placebo comparators.... one for the group of patients with resting PAH and another for the group of patients with exercise PAH
    Intervention: Drug: sildenafil
  • Active Comparator: 2
    There are two active comparators, one group with resting PAH and another with exercise PAH, both receiving drug
    Intervention: Drug: sildenafil
  • No Intervention: 3
    this group of patients has no evidence for either resting or exercise PAH but will be followed without specific drug intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with Idiopathic Pulmonary Fibrosis referred for lung transplantation at our medical center
  • Minimal 6 minute walk distance of 50 meters; must be able to conduct supine exercise during heart catheterization

Exclusion Criteria:

  • Non ambulatory
  • Prior adverse reaction/allergy to sildenafil or other PDE-5 Inhibitors
  • Any other pulmonary vasodilator within one month of enrollment
Both
Not Provided
No
Contact: Rajan Saggar, MD 310-825-5635 rsaggar@mednet.ucla.edu
Contact: Michaela Dyke 310-825-5635 mdyke@mednet.ucla.edu
United States
 
NCT00625079
IPF/PH
Yes
Rajan Saggar, David Geffen School of Medicine UCLA
University of California, Los Angeles
Pfizer
Study Director: Rajan Saggar, MD David Geffen School of Medicine, UCLA
University of California, Los Angeles
February 2008

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