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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 8 August 2016
Main ID:  NCT00352482
Date of registration: 13/07/2006
Prospective Registration: No
Primary sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Public title: Sildenafil to Increase Exercise Capacity in Individuals With Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension
Scientific title: Sildenafil Treatment in Patients With Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension - a Pilot Cross-over Study
Date of first enrolment: November 2004
Target sample size: 20
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
United States
Name:     David A. Zisman, MD
Affiliation:  University of California, Los Angeles
Key inclusion & exclusion criteria

Inclusion Criteria:

- IPF, diagnosed according to the American Thoracic Society (ATS) and European
Respiratory Society (ERS) consensus statement (with or without surgical lung biopsy)

- Pulmonary hypertension, defined as mean pulmonary artery pressure (MPAP) greater than
or equal to 25 mm Hg by right heart catheterization (RHC)

Exclusion Criteria:

- Interstitial lung disease due to conditions other than IPF

- Recent lung or upper respiratory tract infection within 4 weeks of study entry

- Acute or chronic impairment other than dyspnea (e.g., angina pectoris, intermittent
claudication) limiting the ability to comply with study requirements (e.g., 6-minute
walk test)

- Known hypersensitivity to sildenafil

- Known or suspected coronary artery disease (CAD)

- Unstable angina

- Nitrate use

- Known or suspected aortic stenosis (AS)

- Known or suspected heart attack, stroke, or life-threatening arrythmias within 1
month of study entry

- Severe chronic heart failure, defined as New York Heart Association (NYHA) class
III/IV and/or left ventricular ejection fraction less than 25%

- Known penile deformities

- Known kidney or liver dysfunction

- Uncontrolled diabetes (blood glucose less than 60 mg/dl or greater than 300 mg/dl)

- Severe serum sodium abnormalities (serum sodium less than 130 mEq/L or greater than
150 mEq/L)

- Condition that may predispose participant to priapism (e.g., sickle cell anemia,
multiple myeloma, leukemia)

- Retinitis pigmentosa

- Known or suspected idiopathic hypertrophic subaortic stenosis (IHSS)

- Low blood pressure (systolic blood pressure [SBP] less than 100 mm Hg or diastolic
blood pressure [DBP] less than 50 mm Hg)

- Uncontrolled systemic high blood pressure (SBP greater than 180 mm Hg or DBP greater
than 100 mm Hg)

- Cardiopulmonary rehabilitation program started within 8 weeks of study entry or
likely to start prior to the conclusion of the study

- Treatment with an endothelin receptor antagonist, iloprost, epoprostenol, inhibitors
of CYP3A4 (e.g., cimetidine, erythromycin, ketoconazole, itraconazole, mibefradil),
protease inhibitors (e.g., amprenavir, indinavir, or ritonavir), rifampin,
alpha-blockers (e.g., doxazosin), or other phosphodiesterase-5 inhibitors

- Current use of alcohol, grapefruit juice, or St. John's wort

- Pregnant or breastfeeding

Age minimum: 19 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Hypertension, Pulmonary
Pulmonary Fibrosis
Drug: Sildenafil (50 mg)
Primary Outcome(s)
6-minute walk distance (measured at Week 3)
Secondary Outcome(s)
Desaturation index (measured by the 6-minute walk distance multiplied by the SpO2 mean value)
Level of breathlessness (measured by Borg dyspnea index questionnaire) (all measured at Week 3)
Lowest SpO2 with exertion (measured during 6-minute walk test)
Mean SpO2 and area under the curve (measured during 6-minute walk test)
Oxygen saturation (SpO2) at rest
Recovery time (measured during 6-minute walk test)
Total duration of SpO2 below 89% with exertion (measured during 6-minute walk test)
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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