Trial · NCT01884675
Outcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Six Minutes Walking Distance (6MWD) at Week 16 | Baseline (Week 0); Weeks 4, 8, 12 and 16/Early Withdrawal | Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized. | Meters | MEDIAN |
| SECONDARY | Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 16 | Baseline (Week 0) and Week 16 | ITT Population. Only those participants with available data at Baseline and the specified timepoint were analysed. | Dynes*second/centimeter^5 | MEDIAN |
| SECONDARY | Change From Baseline in WHO Functional Class (FC) at Weeks 4, 8, 12 and 16/Early Withdrawal | Baseline (Week 0); Weeks 4, 8, 12 and 16/Early Withdrawal | Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized. | Scores on a scale | MEDIAN |
| SECONDARY | Change From Baseline in Borg CR10 Scale (BCR10S) Immediately Following Exercise at Weeks 4, 8, 12 and 16/Early Withdrawal | Baseline (Week 0); Weeks 4, 8, 12 and 16/Early Withdrawal | Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized. | Scores on a scale | MEDIAN |
| SECONDARY | Number of Participants With Clinical Worsening of Chronic Thromboembolic Pulmonary Hypertension (CTEPH) | From randomization to Week 16/Follow up visit (21 weeks) | ITT Population | Participants | NUMBER |
| SECONDARY | Change From Baseline in Mean Right Atrial Pressure (mRAP) and Mean Pulmonary Artery Pressure (mPAP) at Week 16 | Baseline (Week 0) and Week 16 | Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized. | Millimeter of mercury (mmHg) | MEDIAN |
| SECONDARY | Change From Baseline in Cardiac Index at Week 16 | Baseline (Week 0) and Week 16 | Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint were summarized. | Litre per minute per meter squared | MEDIAN |
| SECONDARY | Percent Change From Baseline in Plasma N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) | Baseline (Week 0); Weeks 4, 8, 12 and 16/Early Withdrawal | Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized. | Percent change | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in Quality of Life as Measured by Short Form 36 Health Survey (SF-36) | Baseline and up to Week 16/Early Withdrawal | ITT Population | ||
| SECONDARY | Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | From the start of study treatment and until follow up (Week 16/Follow up) | ITT Population | Participants | NUMBER |
| SECONDARY | Change From Baseline in Haemoglobin Levels at Weeks 4, 8, 12, and 16/Early Withdrawal | Baseline (Week 0); Weeks 4, 8, 12, and 16/Early Withdrawal | Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized. | Grams per liter | MEDIAN |
| SECONDARY | Change From Baseline in Haematocrit Levels at Weeks 4, 8, 12, and 16/Early Withdrawal | Baseline (Week 0); Weeks 4, 8, 12, and 16/Early Withdrawal | Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized. | Proportion of 1 | MEDIAN |
| SECONDARY | Number of Participants With Significant Liver Events at Weeks 4, 8, 12, and 16/Early Withdrawal | Weeks 4, 8, 12, and 16/Early Withdrawal | ITT Population | Participants | NUMBER |
| SECONDARY | Change From Baseline in Supine Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Assessed at Weeks 4, 8, 12, and 16/Early Withdrawal | Baseline (Week 0); Weeks 4, 8, 12, and 16/Early Withdrawal | Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized. | millimeter of mercury (mmHg) | MEDIAN |
| SECONDARY | Change From Baseline in Heart Rate Assessed at Weeks 4, 8, 12, and 16/Early Withdrawal | Baseline (Week 0); Weeks 4, 8, 12, and 16/Early Withdrawal | Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized. | beats per minute | MEDIAN |
| SECONDARY | Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern Any Time Post Baseline | Baseline (Week 0), Weeks 4, 8, 12 and 16/early withdrawal, | ITT Population | Participants | NUMBER |
| SECONDARY | Number of Participants With Hematology Parameters of Potential Clinical Concern Any Time Post Baseline | Baseline (Week 0), Weeks 4, 8, 12 and 16/early withdrawal | Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized. | Participants | NUMBER |
| SECONDARY | Number of Participants With Testicular Function (Males Only) of Potential Clinical Concern Any Time Post Baseline | Baseline, Weeks 4 and 16/early withdrawal | ITT Population |
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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT01884675/outcomes