Trial · NCT01332331
Efficacy and Safety of Ambrisentan in Children 8-18yrs
NCT01332331, Phase 2, Terminated, GlaxoSmithKline; results first posted 2019-10-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Ambrisentan in Children 8-18yrs. Trials, record NCT01332331. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01332331
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Ambrisentan in Children 8-18yrs
- NCT number
- NCT01332331
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 41 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Hypertension, Pulmonary
- Interventions
- Ambrisentan - low dose, Ambrisentan - high dose
- First posted
- 2011-04-11
- Last updated
- 2019-10-08
- Other registries' IDs
- eudract:2010-019547-19
- Results first posted
- 2019-10-08
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Treatment-emergent Adverse Events (SAEs) | Up to 24 Weeks | AEs defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAEs defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect, medical events that may not immediately life threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention as per medical or scientific judgement and events of drug-induced liver injury with hyperbilirubinaemia. Safety population comprised of all randomized participants who received at least 1 dose of study drug. |
| 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 | Blood samples were collected from participants for analysis of following clinical chemistry parameters: ALT, AST, GGT, total bilirubin and creatinine. PCI ranges were \<3 times the upper limit of normal (ULN), \<34.2 Micromoles per liter (UMOL/L) for total bilirubin and \<176.8 (UMOL/L) for creatinine. Only those parameters having any time post-Baseline PCI values were presented. Day 1 was considered as Baseline. |
| Primary | Number of Participants With Post Baseline PCI Value for Hematology Parameter: Hemoglobin | Up to 24 Weeks | Blood samples were collected from participants for analysis of following hematology parameters: hemoglobin. PCI ranges were Males: 98 to180 grams per liter (G/L), Females: 91 to 161 (G/L) for hemoglobin. Only those parameters having any time post-Baseline PCI values were presented. Day 1 was considered as Baseline. |
| Primary | Number of Participants With Post Baseline PCI Value for Hematology Parameter: Hematocrit | Up to 24 Weeks | Blood samples were collected from participants for analysis of following hematology parameter: hematocrit. PCI ranges were males: \<0.32 to \>0.54, females: \<0.29 to \>0.506 proportion of red blood cells in blood for hematocrit. Only those parameters having any time post-Baseline PCI values were presented. Day 1 was considered as Baseline. |
| Primary | Number of Participants With Post Baseline PCI Value for Hematology Parameter: Platelet Count | Up to 24 Weeks | Blood samples were collected from participants for analysis of following hematology parameter: platelet count. PCI ranges were 100 to 400 for Giga cells per liter platelet count. Only those parameters having any time post-Baseline PCI values were presented. Day 1 was considered as Baseline. |
| Primary | Number of Participants With Abnormal Value for Physical Examination Parameter: Liver Size | Week 12 and 24 | Physical examination included measurement of liver size. Any abnormal enlargement or reduction in the size of the liver is reported. |
| Primary | Number of Participants With Abnormal Value for Physical Examination Parameter: Jugular Venous Pressure | Week 12 and 24 | Physical examination of participants jugular venous pressure is measured. |
| Primary | Number of Participants With Abnormal Value for Physical Examination Parameter: Peripheral Edema | Week 12 and 24 | Physical examination of paricipants peripheral edema is measured. Day 1 was considered as Baseline. |
| Primary | Number of Participants With Abnormal Value for Physical Examination Parameter: Ascites | Week 12 and 24 | Physcial examination of paricipants ascites was measured. Day 1 was considered as Baseline. |
| Primary | Percentage of Physical Examination Parameter: Saturated Oxygen Level | Week 12 and 24 | Physical examination of participants saturated oxygen level was measured. Day 1 was considered as Baseline. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group176
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Treatment-emergent Adverse Events (SAEs) | Low Dose Ambrisentan | Any AEs | 16 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Treatment-emergent Adverse Events (SAEs) | High Dose Ambrisentan | Any AEs | 16 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Treatment-emergent Adverse Events (SAEs) | Low Dose Ambrisentan | Any SAEs | 6 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Treatment-emergent Adverse Events (SAEs) | High Dose Ambrisentan | Any SAEs | 2 | Participants | |
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 | Low Dose Ambrisentan | ALT | 0 | Participants | |
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 | High Dose Ambrisentan | ALT | 0 | Participants | |
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 | Low Dose Ambrisentan | AST | 0 | Participants | |
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 | High Dose Ambrisentan | AST | 0 | Participants | |
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 | Low Dose Ambrisentan | GGT | 0 | Participants | |
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 | High Dose Ambrisentan | GGT | 0 | Participants |
1 to 10 of 176Source ClinicalTrials.gov
See all 176 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Low Dose Ambrisentan | 21 | |
| Overall Study | STARTED | High Dose Ambrisentan | 20 | |
| Overall Study | COMPLETED | Low Dose Ambrisentan | 19 | |
| Overall Study | COMPLETED | High Dose Ambrisentan | 18 | |
| Overall Study | NOT COMPLETED | Low Dose Ambrisentan | 2 | |
| Overall Study | NOT COMPLETED | High Dose Ambrisentan | 2 |
Source ClinicalTrials.gov
Adverse events108
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Heparin-induced thrombocytopenia | Blood and lymphatic system disorders | Low Dose Ambrisentan | 0 | 21 | 0 |
| other | Heparin-induced thrombocytopenia | Blood and lymphatic system disorders | High Dose Ambrisentan | 1 | 20 | 1 |
| other | Lymphopenia | Blood and lymphatic system disorders | Low Dose Ambrisentan | 0 | 21 | 0 |
| other | Lymphopenia | Blood and lymphatic system disorders | High Dose Ambrisentan | 1 | 20 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | Low Dose Ambrisentan | 1 | 21 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | High Dose Ambrisentan | 1 | 20 | 1 |
| other | Cyanosis | Cardiac disorders | Low Dose Ambrisentan | 0 | 21 | 0 |
| other | Cyanosis | Cardiac disorders | High Dose Ambrisentan | 1 | 20 | 1 |
| other | Palpitations | Cardiac disorders | Low Dose Ambrisentan | 1 | 21 | 1 |
| other | Palpitations | Cardiac disorders | High Dose Ambrisentan | 1 | 20 | 1 |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Low Dose Ambrisentan | 1 | 21 |
| Total, all-cause mortality | High Dose Ambrisentan | 0 | 20 |
| Total, other adverse events | Low Dose Ambrisentan | 16 | 21 |
| Total, other adverse events | High Dose Ambrisentan | 16 | 20 |
| Total, serious adverse events | Low Dose Ambrisentan | 6 | 21 |
| Total, serious adverse events | High Dose Ambrisentan | 2 | 20 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Low Dose Ambrisentan vs High Dose Ambrisentan: deaths from any cause | Trial comparisons |
| Low Dose Ambrisentan vs High Dose Ambrisentan: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01332331
GET https://conductscience.org/api/trials/v1/NCT01332331/registered?page=2