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Comparison · NCT00517933-56f65bed

Sildenafil vs Placebo: Change in 6-minute Walk Distance From Enrollment to Week 12 (≥ 20% Improvement)

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Sildenafil vs Placebo: Change in 6-minute Walk Distance From Enrollment to Week 12 (≥ 20% Improvement). Trial comparisons, record NCT00517933-56f65bed. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00517933-56f65bed

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.1010.05410.181wilson
Risk in group 20.06590.03060.136wilson
Risk difference, group 1 minus group 20.0352-0.04960.123newcombe hybrid score
Risk ratio, group 1 over group 21.530.5694.13log
Odds ratio, group 1 over group 21.590.5434.68log
Number needed to treat, for one more participant with the outcome on Sildenafil than on Placebo28.4from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Sildenafil20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.989OG000
Group 2Placebo20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks691OG001

Outcome

Type
PRIMARY
Title
Change in 6-minute Walk Distance From Enrollment to Week 12 (≥ 20% Improvement)
Description
This is a binary score (1 or 0) with 1 being better than 0. All models adjust for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.
Time frame
Measured at Week 12
Population

Source ClinicalTrials.gov

Trial

Title
Sildenafil Trial of Exercise Performance in Idiopathic Pulmonary Fibrosis
NCT number
NCT00517933
Phases
PHASE3
Conditions
Pulmonary Fibrosis, Hypertension, Pulmonary
Interventions
Sildenafil Citrate, Placebo
Lead sponsor
Duke University
Results first posted
2013-08-23

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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