Trial · NCT01332331
Outcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Treatment-emergent Adverse Events (SAEs) | Up to 24 Weeks | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Post Baseline Potential Clinical Importance (PCI) Value for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT), Total Bilirubin and Creatinine | Up to 24 Weeks | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Post Baseline PCI Value for Hematology Parameter: Hemoglobin | Up to 24 Weeks | Safety population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Post Baseline PCI Value for Hematology Parameter: Hematocrit | Up to 24 Weeks | Safety population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Post Baseline PCI Value for Hematology Parameter: Platelet Count | Up to 24 Weeks | Safety population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Value for Physical Examination Parameter: Liver Size | Week 12 and 24 | Safety population. Only those participants with available data at the specified time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Value for Physical Examination Parameter: Jugular Venous Pressure | Week 12 and 24 | Safety population. Only those participants with available data at the specified time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Value for Physical Examination Parameter: Peripheral Edema | Week 12 and 24 | Safety population. Only those participants with available data at the specified time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Value for Physical Examination Parameter: Ascites | Week 12 and 24 | Safety population. Only those participants with available data at the specified time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percentage of Physical Examination Parameter: Saturated Oxygen Level | Week 12 and 24 | Safety population. Only those participants with available data at the specified time points were analyzed. | Percentage of oxygen saturation | MEAN |
| PRIMARY | Number of Participants With Post Baseline PCI Value for Vital Signs Parameter: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Up to 24 Weeks | Safety population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Post Baseline PCI Value for Vital Signs Parameter: Heart Rate | Up to 24 Weeks | Safety population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Post Baseline PCI Value for Vital Signs Parameter: Weight | Up to 24 Weeks | Safety population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline of Pubertal Development: Men- Testicular Volume (TV) at Weeks 12 and 24 | Baseline, Week 12 and 24 | Safety population. Only those male participants with available data at the specified time points were analyzed. | Milliliter | MEAN |
| PRIMARY | Change From Baseline in Plasma Endocrine Parameter - Female : Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) at Weeks 12 and 24 | Baseline, Week 12 and 24 | Safety population. Only those female participants with available data at the specified time points were analyzed. | International unit per Liter | MEAN |
| PRIMARY | Change From Baseline in Plasma Endocrine Parameter - Female : Inhibin B at Weeks 12 and 24 | Baseline, Week 12 and 24 | Safety population. Only those female participants with available data at the specified time points were analyzed. | Nanogram per liter | MEAN |
| PRIMARY | Change From Baseline in Plasma Endocrine Parameter - Female : Sex Hormone Binding Globulin at Weeks 12 and 24 | Baseline, Week 12 and 24 | Safety population. Only those female participants with available data at the specified time points were analyzed. | Milliliter | MEAN |
| SECONDARY | Change From Baseline in the 6 Minutes Walking Distance (6MWD) Test | Baseline, Weeks 4, 8, 12, 16, 20 and 24 | Intent-to-treat population. Only those participants with available data at the specified time points were analyzed. | Meters | MEAN |
| SECONDARY | Time to the First Clinical Worsening of Pulmonary Arterial Hypertension (PAH) | Up to Week 24 | Intent-to-treat population. Only those participants with available data at the specified time points were analyzed. | Days | MEAN |
| SECONDARY | Change From Baseline in Subject Global Assessment to Week 24 Using the SF-10 Health Survey for Children | Baseline and Week 24 | Intent-to-treat population. Only those participants with available data at the specified time points were analyzed. | Scores on a scale | 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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01332331/outcomes