Trial · NCT00517933
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 30
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in 6-minute Walk Distance From Enrollment to Week 12 (≥ 20% Improvement) | Measured at Week 12 | 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. |
| Secondary | 6-minute Walk Distance (6MWT) | Baseline, 6 week, 12 week | The 6MWT measures the distance that a participant can walk in a period of 6 minutes. |
| Secondary | Estimated Change From Baseline to 12 Weeks in 6-minute Walk Distance | Baseline, week 12 | The 6MWT measures the distance that a participant can walk in a period of 6 minutes. 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. |
| Secondary | Desaturation During 6-minute Walk Test (6MWT) | Week 12 | The 6MWT was stopped when the pulse oximetry (SpO2) dropped to below 80% for six consecutive seconds. The estimates are based on the Kaplan-Meier event curves with minutes walked as the x-axis. |
| Secondary | Change in Dyspnea | Measured from enrollment to 12 weeks (phase I) | The University of California at San Diego Shortness of Breath Questionnaire (SOBQ) uses a 6-point scale (0 = "not at all" to 5 = "maximal or unable to do because of breathlessness") to rate 24 items. The final score ranges from 0 to 120 -- lower scores are better. |
| Secondary | University of California at San Diego (UCSD) Shortness of Breath Questionnaire Total | Baseline, 6 weeks, 12 weeks | The University of California at San Diego Shortness of Breath Questionnaire (SOBQ) uses a 6-point scale (0 = "not at all" to 5 = "maximal or unable to do because of breathlessness") to rate 24 items. The final score ranges from 0 to 120 -- lower scores are better. (Raw scores) Values adjusted 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. |
| Secondary | Change in Forced Vital Capacity (FVC) Adjusted Values | Baseline, Week 12 | Change in FVC (liters) from baseline (time 0) to week 12 comparing the sildenafil and placebo groups. Values adjusted 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. |
| Secondary | Forced Vital Capacity (FVC) | Baseline, Week 6, Week 12 | Raw scores of FVC (liters) from baseline (time 0) to week 6 and 12 comparing the sildenafil and placebo groups |
| Secondary | Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) Adjusted Values | Baseline, Week 12 | Change in DLCO (% predicted) measured at baseline (time 0), and week 12 comparing the sildenafil and placebo groups. 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. |
| Secondary | Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) | Baseline, Week 6, Week 12 | Raw scores of DLCO (% predicted) measured at baseline (time 0), week 6, and week 12 comparing the sildenafil and placebo groups |
| Secondary | Change in Borg Dyspnea Index (BDI) After 6 Minute Walk Test (Adjusted Values) | Baseline, 12 week | The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum) and indicates the degree of breathlessness after completion of the 6-minute walk test. Values adjusted 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. |
| Secondary | Borg Dyspnea Index (BDI) After 6 Minute Walk Test (Raw Scores) | Baseline, 6 week, 12 week | The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum) and indicates the degree of breathlessness after completion of the 6-minute walk test. |
| Secondary | Change in St. George's Respiratory Questionnaire (Total Score) (Adjusted Values) | Baseline, 12 week | The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment.) Values adjusted 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. |
| Secondary | St. George's Respiratory Questionnaire (Total Score) | Baseline, 6 weeks, 12 weeks | Mean raw scores of the St. George's Respiratory Questionnaire. The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment.) |
| Secondary | Change in St. George's Respiratory Questionnaire (Symptoms Score) Adjusted Value | Baseline, 12 weeks | The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Values adjusted 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. |
| Secondary | St. George's Respiratory Questionnaire (Symptoms Score) | Baseline, 6 weeks, 12 weeks | The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Mean raw scores of the St. George's Respiratory Questionnaire. Mean raw scores of the St. George's Respiratory Questionnaire. |
| Secondary | Change in St. George's Respiratory Questionnaire (Activity Score) Adjusted Value | Baseline, 12 weeks | The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Values adjusted 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. |
| Secondary | St. George's Respiratory Questionnaire (Activity Score) | Baseline, 6 weeks, 12 weeks | The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Mean raw scores of the St. George's Respiratory Questionnaire. |
| Secondary | Change in St. George's Respiratory Questionnaire (Impacts Score) Adjusted Value | Baseline, 12 weeks | The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Values adjusted 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. |
| Secondary | St. George's Respiratory Questionnaire (Impacts Score) | Baseline, 6 weeks, 12 weeks | The St. George's Respiratory Questionnaire asks patients how breathing problems impair their life and is scored from 0 (no impairment) to 100 (maximum impairment). Mean raw scores of the St. George's Respiratory Questionnaire. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT00517933/registered