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Trial · NCT00796666

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYTime to Clinical Worsening (TTCW)Baseline, Weeks 12, 24 or Early Termination (ET)Intent-to-Treat population (ITT): all participants who were randomizedDaysMEDIAN
SECONDARYChange From Baseline in the Total Distance Walked During 6 Minute Walk Distance (6MWD)Baseline to Weeks 12 and 24ITT; N=number of participants analyzed; Missing values at Weeks 12 and 24 imputed with the last non-missing 6MWD based on the last observation carried forward (LOCF) methodmeters (m)MEAN
SECONDARYChange From Baseline in World Health Organization (WHO) Functional Class in Participants With PAH at Weeks 12, 24, 48Baseline, Weeks 12, 24 or ETITTparticipantNUMBER
SECONDARYChange in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Physical Functioning DomainBaseline, Weeks 12, 24 and ETITT; N=number of participants analyzedunits on a scaleMEAN
SECONDARYChange in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Role Limitations Due to Physical Health Problems DomainBaseline, Weeks 12, 24 or ETITT; N=number of participants analyzedunits on a scaleMEAN
SECONDARYChange in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Bodily Pain DomainBaseline, Weeks 12, 24 or ETITT; N=number of participants analyzedunits on a scaleMEAN
SECONDARYChange in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - General Health DomainBaseline, Weeks 12, 24 or ETITT; N=number of participants analyzedunits on a scaleMEAN
SECONDARYChange in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Vitality DomainBaseline, Weeks 12, 24 or ETITT; N=number of participants analyzedunits on a scaleMEAN
SECONDARYChange in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Social Functioning DomainBaseline, Weeks 12, 24 or ETITT; N=number of participants analyzedunits on a scaleMEAN
SECONDARYChange in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Role Limitation Due to Emotional Problems DomainBaseline, Weeks 12, 24 or ETITT; N=number of participants analyzedunits on a scaleMEAN
SECONDARYChange in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Mental Health DomainBaseline, Weeks 12, 24 or ETITT; N=number of participants analyzedunits on a scaleMEAN
SECONDARYChange in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Composite Mental HealthBaseline, Weeks 12, 24 or ETITT; N=number of participants analyzedunits on a scaleMEAN
SECONDARYChange in 36-Item Short-Form Health Survey (SF-36) From Baseline at Weeks 12, 24 and 48 - Composite Physical HealthBaseline, Weeks 12, 24 or ETITT; N=number of participants analyzedunits on a scaleMEAN

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.

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