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Phase 2 Completed N=29 Randomized Quadruple-blind Treatment

Sildenafil Study to Treat Idiopathic Pulmonary Fibrosis

Alveolitis, Fibrosing · Fibrosis, Pulmonary · Hypertension, Pulmonary
Source: ClinicalTrials.gov NCT00359736 ↗
Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcomePrimary: Change in 6-minute Walk Test — -26; -7 meters

Summary

Medicines that decrease blood pressure in the lungs may help idiopathic pulmonary fibrosis (IPF) patients function better. This study will test whether sildenafil improves the ability to exercise in patients with pulmonary fibrosis of unknown cause.

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in 6-minute Walk Test
-26; -7
SECONDARY
Dyspnea Score (Borg Scale)
0.86; 0.38; 0.89; 0.15

Eligibility Criteria

Inclusion Criteria

  • Clinical diagnosis of IPF
  • 40-85 years of age
  • 6-minute walk distance 150-500 m
  • FVC 40-90% predicted
  • DLCO 30-90% predicted

Exclusion Criteria

  • Severe pulmonary hypertension
  • Severe heart failure
  • FEV1/FVC < 0.7
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00359736). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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