Trial · NCT01808313
Outcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in 6-minutes Walk Test (6MWT) at Week 12 | Baseline and Week 12 | Intent-to-Treat (ITT) Population: all participants who received at least one dose of study medication and had an efficacy assessment performed both at Baseline and after administration of the study medication | Meters | MEAN |
| SECONDARY | Change From Baseline in 6MWT at Week 24 | Baseline and Week 24 | ITT Population. | Meters | MEAN |
| SECONDARY | Number of Participants With a Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 12 and 24 | Baseline, Week 12 and Week 24 | ITT Population | Participants | NUMBER |
| SECONDARY | Change From Baseline in the Borg Dyspnea Index (BDI) at Weeks 12 and 24 | Baseline, Week 12 and Week 24 | ITT Population. | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in the N-Terminal Pro-B-Type Natriuretic Peptide at Weeks 12 and 24 | Baseline, Week 12 and Week 24 | ITT Population. Only those participants available at the specified time points were analyzed (represented by number of participants \[n\]=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflect everyone in the ITT Population. | log(ng/L) | MEAN |
| SECONDARY | Number of Participants With the Indicated Event, as an Assessment of Time to Clinical Worsening of Pulmonary Arterial Hypertension (PAH) up to Week 24, Assessed as the First Occurrence of a Particular Event | Baseline up to Week 24 | Safety Population: This population comprised of all participants who received at least one dose of study medication. | Participants | NUMBER |
| SECONDARY | Number of Participants With Any Adverse Events, Any Serious Adverse Events and Adverse Events Leading to Discontinuation | From the start of study treatment up to Week 24 | Safety Population | Participants | NUMBER |
| SECONDARY | Number of Participants With Physical Examination Findings | Baseline, Week 12 and Week 24 | Safety Population | Participants | NUMBER |
| SECONDARY | Change From Baseline in Electrocardiogram (ECG) Heart Rate Values at Weeks 12 and 24 | Baseline, Week 12 and Week 24 | Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population. | Beats per minute | MEAN |
| SECONDARY | Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Interval Corrected Bazett's Formula (QTcB) Values at Weeks 12 and 24 | Baseline, Week 12 and Week 24 | Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population. | Milliseconds | MEAN |
| SECONDARY | Change From Baseline in Systolic and Diastolic Blood Pressure at the Indicated Time Points up to Week 24 | Baseline up to Week 24 | Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population. | Millimeters of mercury (mmHg) | MEAN |
| SECONDARY | Change From Baseline in Heart Rate at the Indicated Time Points up to Week 24 | Baseline up to Week 24 | Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population. | Beats per minute | MEAN |
| SECONDARY | Oral Temperature | Baseline | Safety Population | Celsius | MEAN |
| SECONDARY | Number of Participants With Shift From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST) and Total Bilirubin (BILT) up to Week 24 | Baseline up to Week 24 | Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population. | Participants | NUMBER |
| SECONDARY | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell (WBC) Count at the Indicated Time Points up to Week 24 | Baseline up to Week 24 | Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population. | Giga cells per liter | MEAN |
| SECONDARY | Change From Baseline in Hemoglobin at the Indicated Time Points up to Week 24 | Baseline up to Week 24 | Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population. | Grams per liter | MEAN |
| SECONDARY | Change From Baseline in Hematocrit at the Indicated Time Points up to Week 24 | Baseline up to Week 24 | Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population. | Proportion of 1 | MEAN |
| SECONDARY | Change From Baseline in Mean Corpuscle Hemoglobin at the Indicated Time Points up to Week 24 | Baseline up to Week 24 | Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population. | Picogram | MEAN |
| SECONDARY | Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points up to Week 24 | Baseline up to Week 24 | Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population. | Femtoliters | MEAN |
| SECONDARY | Change From Baseline in Red Blood Cell (RBC) Count at the Indicated Time Points up to Week 24 | Baseline up to Week 24 | Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population. | Trillion cells per liter | MEAN |
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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