Trial · NCT01342952
Long-term Ambrisentan Extension Study for Pediatric Patients Who Participated in AMB112529
NCT01342952, Phase 2, Completed, GlaxoSmithKline; results first posted 2022-12-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Long-term Ambrisentan Extension Study for Pediatric Patients Who Participated in AMB112529. Trials, record NCT01342952. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01342952
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-term Ambrisentan Extension Study for Pediatric Patients Who Participated in AMB112529
- NCT number
- NCT01342952
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 38 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Hypertension, Pulmonary
- Interventions
- Ambrisentan
- First posted
- 2011-04-27
- Last updated
- 2022-12-30
- Other registries' IDs
- eudract:2010-021572-29
- Results first posted
- 2022-12-30
Source ClinicalTrials.gov
Registered outcomes56
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Non-serious Treatment-emergent Adverse Events (Non-STEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) | Up to 10 years and 11 months | AE was defined as any untoward medical occurrence in participant or clinical investigation participant,temporally associated with use of medicinal product, whether or not considered related to medicinal product.SAE was 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 congenital anomaly or birth defect, important medical events that may not immediately life threatening or result in death or hospitalization but may jeopardize participant or may require medical or surgical intervention as per medical or scientific judgement or associated with drug-induced liver injury.TEAE is any event that was not present prior to initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. TEAEs which were not serious TEAEs were considered as non serious TEAEs. |
| Primary | Change From Baseline in Liver Function Parameters: Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Total Bilirubin | Baseline (Day 1) and up to 10 years and 11 months | Blood samples were collected from participants for analysis of following clinical chemistry parameters: ALT, AST, GGT, total bilirubin. Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting the Baseline value from the end of study post-dose visit value. |
| Primary | Change From Baseline in Chemistry Parameters: Calcium, Chloride, Carbon Dioxide (CO2) Content, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Blood Urea Nitrogen (BUN) | Baseline (Day 1) and up to 10 years and 11 months | Blood samples were collected from participants for analysis of following clinical chemistry parameters: Calcium, chloride, CO2 content, glucose, potassium, magnesium, sodium, phosphorus inorganic, and BUN. Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting the Baseline value from the end of study post-dose visit value. |
| Primary | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Creatine Kinase (CK), Lactate Dehydrogenase (LDH) | Baseline (Day 1) and up to 10 years and 11 months | Blood samples were collected from participants for analysis of following clinical chemistry parameters: ALP, CK, LDH. Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting the Baseline value from the end of study post-dose visit value. |
| Primary | Change From Baseline in Chemistry Parameters: Creatinine, Uric Acid | Baseline (Day 1) and up to 10 years and 11 months | Blood samples were collected from participants for analysis of following clinical chemistry parameters: Creatinine, uric acid. Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting the Baseline value from the end of study post-dose visit value. |
| Primary | Change From Baseline in Chemistry Parameters: Albumin, Total Protein | Baseline (Day 1) and up to 10 years and 11 months | Blood samples were collected from participants for analysis of following clinical chemistry parameters: Albumin, total protein. Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting the Baseline value from the end of study post-dose visit value. |
| Primary | Change From Baseline in Hematology Parameters: Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Baseline (Day 1) and up to 10 years and 11 months | Blood samples were collected from participants for analysis of following hematology parameters: Hemoglobin and MCHC. Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting the Baseline value from the end of study post-dose visit value. |
| Primary | Change From Baseline in Hematology Parameters: Hematocrit | Baseline (Day 1) and up to 10 years and 11 months | Blood samples were collected from participants for analysis of following hematology parameters: Hematocrit. Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting the Baseline value from the end of study post-dose visit value. |
| Primary | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC), Platelet Count | Baseline (Day 1) and up to 10 years and 11 months | Blood samples were collected from participants for analysis of following hematology parameters: Basophils, eosinophils, lymphocytes, monocytes, total neutrophils, WBC, platelet count. Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting the Baseline value from the end of study post-dose visit value. |
| Primary | Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin | Baseline (Day 1) and up to 10 years and 11 months | Blood samples were collected from participants for analysis of following hematology parameter: Mean Corpuscle Hemoglobin. Baseline was the last value recorded prior to start of study treatment from AMB112529. Change from Baseline was calculated by subtracting the Baseline value from the end of study post-dose visit value. |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 registered outcomesOutcomes56
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 Non-serious Treatment-emergent Adverse Events (Non-STEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) | Up to 10 years and 11 months | Safety Population consisted of all participants who received at least 1 dose of study drug. Participants were considered as belonging to the treatment group according to the highest dose received in the extension study (AMB114588) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in Liver Function Parameters: Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Total Bilirubin | Baseline (Day 1) and up to 10 years and 11 months | Safety Population. Only those participants with available data at the specified time points were analyzed. | Millimoles per liter | MEAN |
| PRIMARY | Change From Baseline in Chemistry Parameters: Calcium, Chloride, Carbon Dioxide (CO2) Content, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Blood Urea Nitrogen (BUN) | Baseline (Day 1) and up to 10 years and 11 months | Safety Population. Only those participants with available data at the specified time points were analyzed. | Millimoles per liter | MEAN |
| PRIMARY | Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Creatine Kinase (CK), Lactate Dehydrogenase (LDH) | Baseline (Day 1) and up to 10 years and 11 months | Safety Population. Only those participants with available data at the specified time points were analyzed. | International units per Liter | MEAN |
| PRIMARY | Change From Baseline in Chemistry Parameters: Creatinine, Uric Acid | Baseline (Day 1) and up to 10 years and 11 months | Safety Population. Only those participants with available data at the specified time points were analyzed. | Micromoles per liter | MEAN |
| PRIMARY | Change From Baseline in Chemistry Parameters: Albumin, Total Protein | Baseline (Day 1) and up to 10 years and 11 months | Safety Population. Only those participants with available data at the specified time points were analyzed. | Grams per liter | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameters: Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Baseline (Day 1) and up to 10 years and 11 months | Safety Population. Only those participants with available data at the specified time points were analyzed. | Grams per Liter | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameters: Hematocrit | Baseline (Day 1) and up to 10 years and 11 months | Safety Population. Only those participants with available data at the specified time points were analyzed. | Proportion of red blood cells in blood | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, White Blood Cells (WBC), Platelet Count | Baseline (Day 1) and up to 10 years and 11 months | Safety Population. Only those participants with available data at the specified time points were analyzed. | Giga cells per Liter | MEAN |
| PRIMARY | Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin | Baseline (Day 1) and up to 10 years and 11 months | Safety Population. Only those participants with available data at the specified time points were analyzed. | Picograms | MEAN |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 outcomesResults by group373
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 Non-serious Treatment-emergent Adverse Events (Non-STEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) | Ambrisentan 2.5 mg (Safety) | Non-STEAEs | 3 | Participants | |
| Number of Participants With Non-serious Treatment-emergent Adverse Events (Non-STEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) | Ambrisentan 5 mg (Safety) | Non-STEAEs | 13 | Participants | |
| Number of Participants With Non-serious Treatment-emergent Adverse Events (Non-STEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) | Ambrisentan 7.5 mg (Safety) | Non-STEAEs | 5 | Participants | |
| Number of Participants With Non-serious Treatment-emergent Adverse Events (Non-STEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) | Ambrisentan 10 mg (Safety) | Non-STEAEs | 10 | Participants | |
| Number of Participants With Non-serious Treatment-emergent Adverse Events (Non-STEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) | Ambrisentan 2.5 mg (Safety) | STEAEs | 2 | Participants | |
| Number of Participants With Non-serious Treatment-emergent Adverse Events (Non-STEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) | Ambrisentan 5 mg (Safety) | STEAEs | 7 | Participants | |
| Number of Participants With Non-serious Treatment-emergent Adverse Events (Non-STEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) | Ambrisentan 7.5 mg (Safety) | STEAEs | 4 | Participants | |
| Number of Participants With Non-serious Treatment-emergent Adverse Events (Non-STEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) | Ambrisentan 10 mg (Safety) | STEAEs | 8 | Participants | |
| Change From Baseline in Liver Function Parameters: Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Total Bilirubin | Ambrisentan 2.5 mg (Safety) | ALT | -7.5 | Standard Deviation 12.56 | Millimoles per liter |
| Change From Baseline in Liver Function Parameters: Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT), Total Bilirubin | Ambrisentan 5 mg (Safety) | ALT | -1.0 | Standard Deviation 8.64 | Millimoles per liter |
1 to 10 of 373Source ClinicalTrials.gov
See all 373 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ambrisentan 2.5 mg (ITT) | 9 | |
| Overall Study | STARTED | Ambrisentan 5 mg (ITT) | 19 | |
| Overall Study | STARTED | Ambrisentan 7.5 mg (ITT) | 5 | |
| Overall Study | STARTED | Ambrisentan 10 mg (ITT) | 5 | |
| Overall Study | Intent-to-Treat Population | Ambrisentan 2.5 mg (ITT) | 9 | |
| Overall Study | Intent-to-Treat Population | Ambrisentan 5 mg (ITT) | 19 | |
| Overall Study | Intent-to-Treat Population | Ambrisentan 7.5 mg (ITT) | 5 | |
| Overall Study | Intent-to-Treat Population | Ambrisentan 10 mg (ITT) | 5 | |
| Overall Study | Safety Population | Ambrisentan 2.5 mg (ITT) | 4 | |
| Overall Study | Safety Population | Ambrisentan 5 mg (ITT) | 16 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events900
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 | Iron deficiency anaemia | Blood and lymphatic system disorders | Ambrisentan 2.5 mg (Safety) | 0 | 4 | 0 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Ambrisentan 5 mg (Safety) | 3 | 16 | 3 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Ambrisentan 7.5 mg (Safety) | 0 | 6 | 0 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Ambrisentan 10 mg (Safety) | 0 | 12 | 0 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Ambrisentan 2.5 mg (Safety) | 0 | 4 | 0 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Ambrisentan 5 mg (Safety) | 0 | 16 | 0 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Ambrisentan 7.5 mg (Safety) | 1 | 6 | 1 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Ambrisentan 10 mg (Safety) | 0 | 12 | 0 |
| other | Lymphoid tissue hyperplasia | Blood and lymphatic system disorders | Ambrisentan 2.5 mg (Safety) | 0 | 4 | 0 |
| other | Lymphoid tissue hyperplasia | Blood and lymphatic system disorders | Ambrisentan 5 mg (Safety) | 1 | 16 | 1 |
1 to 10 of 900Source ClinicalTrials.gov
See all 900 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ambrisentan 2.5 mg (Safety) | 0 | 4 |
| Total, all-cause mortality | Ambrisentan 5 mg (Safety) | 4 | 16 |
| Total, all-cause mortality | Ambrisentan 7.5 mg (Safety) | 1 | 6 |
| Total, all-cause mortality | Ambrisentan 10 mg (Safety) | 2 | 12 |
| Total, other adverse events | Ambrisentan 2.5 mg (Safety) | 3 | 4 |
| Total, other adverse events | Ambrisentan 5 mg (Safety) | 13 | 16 |
| Total, other adverse events | Ambrisentan 7.5 mg (Safety) | 5 | 6 |
| Total, other adverse events | Ambrisentan 10 mg (Safety) | 10 | 12 |
| Total, serious adverse events | Ambrisentan 2.5 mg (Safety) | 2 | 4 |
| Total, serious adverse events | Ambrisentan 5 mg (Safety) | 7 | 16 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01342952
GET https://conductscience.org/api/trials/v1/NCT01342952/registered?page=2