Trial · NCT01894022
Outcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) | From entry visit of the extension study up to approximately 16 months | Safety (Extension) Population | Participants | NUMBER |
| PRIMARY | Change From Study AMB115811 Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Absolute Neutrophil Count [ANC]), Platelet Count, and White Blood Cell (WBC) Count at the Indicated Time Points | Baseline from study AMB115811; Entry visit of the extension study; Months 1, 3, 6, 9, 12, 15; and End of Study (assessed up to approximately 16 months) | Safety (Extension) Population | Giga per Liter (GI/L) | MEDIAN |
| PRIMARY | Change From Study AMB115811 Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at the Indicated Time Points | Baseline from study AMB115811; Entry visit of the extension study; Months 1, 3, 6, 9, 12, 15; and End of Study (assessed up to approximately 16 months) | Safety (Extension) Population | Grams per Liter (g/L) | MEDIAN |
| PRIMARY | Change From Study AMB115811 Baseline in Hematocrit at the Indicated Time Points | Baseline from study AMB115811; Entry visit of the extension study; Months 1, 3, 6, 9, 12, 15; and End of Study (assessed up to approximately 16 months) | Safety (Extension) Population | Ratio | MEDIAN |
| PRIMARY | Change From Study AMB115811 Baseline in Mean Corpuscle Volume at the Indicated Time Points | Baseline from study AMB115811; Entry visit of the extension study; Months 1, 3, 6, 9, 12, 15; and End of Study (assessed up to approximately 16 months) | Safety (Extension) Population | Femtoliter (fL) | MEDIAN |
| PRIMARY | Change From Study AMB115811 Baseline in Red Blood Cell Count and Reticulocytes at the Indicated Time Points | Baseline from study AMB115811; Entry visit of the extension study; Months 1, 3, 6, 9, 12, 15; and End of Study (assessed up to approximately 16 months) | Safety (Extension) Population | Tera per Liter (TI/L) | MEDIAN |
| PRIMARY | Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern at Any Time Post Entry Visit | Post entry visit of the extension study and up to End of Study (assessed up to approximately 16 months) | Safety (Extension) Population | Participants | NUMBER |
| PRIMARY | Number of Participants With Creatinine Values of Potential Clinical Concern at Any Time Post Entry Visit | Entry visit of the extension study; Months 1, 3, 6, 9, 12, 15; and End of Study plus any unscheduled lab tests (assessed up to approximately 16 months) | Safety (Extension) Population | Participants | NUMBER |
| PRIMARY | Change From Study AMB115811 Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Assessed at the Indicated Time Points | Baseline from study AMB115811; Entry visit of the extension study; Months 1, 3, 6, 9, 12, 15; and End of Study (assessed up to approximately 16 months) | Safety (Extension) Population | millimeter of mercury (mmHg) | MEDIAN |
| PRIMARY | Change From Study AMB115811 Baseline in Heart Rate at the Indicated Time Points | Baseline from study AMB115811; Entry visit of the extension study; Months 1, 3, 6, 9, 12, 15; and End of Study (assessed up to approximately 16 months) | Safety (Extension) Population | beats per minute | MEDIAN |
| PRIMARY | Change From Study AMB115811 Baseline in Weight at the Indicated Time Points | Baseline from study AMB115811; Entry visit of the extension study; Months 1, 3, 6, 9, 12, 15; and End of Study (assessed up to approximately 16 months) | Safety (Extension) Population | kilogram (kg) | MEDIAN |
| PRIMARY | Time to First Change in Dose of Open-label Ambrisentan Due to Tolerability Issues in Any Participant | From the Entry visit of the extension study up to approximately 16 months | Safety (Extension) Population | ||
| SECONDARY | Change From Study AMB115811 Baseline in the 6 Minutes Walking Distance (6MWD) at the Indicated Time Points | During Study AMB115811: Months 0 (Baseline), 1, 2, 3, 4, Early Withdrawal (EW); During Extension Study: Months 1, 3, 6, 9, 12, 15 and at End of Study (assessed up to approximately 20 months) | ITT Population | Meters | MEDIAN |
| SECONDARY | Change From Study AMB115811 Baseline (BL) in World Health Organization (WHO) Functional Class (FC) at the Indicated Time Points | During Study AMB115811: Months (M) 0 (Baseline), 1, 2, 3, 4, Early Withdrawal (EW); During Extension (ext) Study: Months 1, 3, 6, 9, 12, 15 and at End of Study (assessed up to approximately 20 months) | ITT Population | Scores on a scale | MEDIAN |
| SECONDARY | Change From Study AMB115811 Baseline in Borg CR10 Scale (BCR10S) Immediately Following Exercise at the Indicated Time Points | During Study AMB115811: Months (M) 0 (Baseline), 1, 2, 3, 4, Early Withdrawal (EW); During Extension (Ext) Study: Months 1, 3, 6, 9, 12, 15 and at End of Study (assessed up to approximately 20 months) | ITT Population | Scores on a scale | MEDIAN |
| SECONDARY | Number of Participants With Clinical Worsening of Chronic Thromboembolic Pulmonary Hypertension (CTEPH) | From randomization up to End of Study for the extension study (assessed up to approximately 20 months) | ITT Population | Participants | NUMBER |
| SECONDARY | Change From Study AMB115811 Baseline in Quality of Life as Measured by Short Form 36 Health Survey (SF-36) | Baseline from study AMB115811 up to End of Study for the extension study (assessed up to approximately 20 months) | ITT Population | ||
| SECONDARY | Percent Change From Study AMB115811 Baseline in Plasma N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) | During Study AMB115811: Months 0 (Baseline), 1, 2, 3, 4, Early Withdrawal (EW); During Extension Study: Months 1, 3, 6, 9, 12, 15 and at End of Study (assessed up to approximately 20 months) | ITT Population | Percent change | GEOMETRIC_MEAN |
| SECONDARY | Change From Start of Ambrisentan Treatment in 6 Minutes Walking Distance at the Indicated Time Points | Previous Placebo: Months 0 (Entry visit of the extension), 1, 3, 6, 9, 12; Previous Ambrisentan: Month 0 (Baseline of study AMB115811), 1, 2, 3, 4, Early Withdrawal (EW) (AMB115811), 5, 7, 10, 13, 16, 19; and at End of Study | ITT Population. Placebo arm: includes par. who received ambrisentan treatment during extension study | Meters | MEDIAN |
| SECONDARY | Change From Start of Ambrisentan Treatment in World Health Organization (WHO) Functional Class (FC) at the Indicated Time Points | Previous Placebo: Months 0 (Entry visit of the extension), 1, 3, 6, 9, 12; Previous Ambrisentan: Month 0 (Baseline of study AMB115811), 1, 2, 3, 4, Early Withdrawal (EW) (AMB115811), 5, 7, 10, 13, 16, 19; and at End of Study | ITT Population. Placebo arm: includes par. who received ambrisentan treatment during extension study | Scores on a scale | MEDIAN |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01894022/outcomes