Trial · NCT01894022
A Open Label Study to Assess the Long-term Safety, Tolerability and Efficacy of Ambrisentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
NCT01894022, Phase 3, Terminated, GlaxoSmithKline; results first posted 2017-06-08
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Open Label Study to Assess the Long-term Safety, Tolerability and Efficacy of Ambrisentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH). Trials, record NCT01894022. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01894022
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Open Label Study to Assess the Long-term Safety, Tolerability and Efficacy of Ambrisentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
- NCT number
- NCT01894022
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 19 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Hypertension
- Interventions
- Ambrisentan 5 mg
- First posted
- 2013-07-09
- Last updated
- 2017-09-11
- Results first posted
- 2017-06-08
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious Adverse Event (SAE) is 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/incapacity, is a congenital anomaly/birth defect. Refer to the general AE/SAE module for a list of AEs and SAEs. Participant's final visit in Study AMB115811 was used as the entry visit of this open-label extension study. Safety (Extension) Population: all participants who enrolled and took at least one dose of study treatment during the extension study. |
| 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) | Hematology parameters were assessed at Entry visit of the extension study, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, and end of study. Change from study AMB115811 Baseline in basophils, eosinophils, lymphocytes, monocytes, total neutrophils (ANC), platelet count, and WBC count are summarized. AMB115811 Baseline is the last value recorded on or prior to start of study treatment in that study. Change from AMB115811 Baseline was calculated as the value at the indicated visit minus the Baseline value. Participant's final visit in Study AMB115811 was used as the entry visit of this open-label extension study. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA indicates that data were not available. |
| 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) | Hematology parameters were assessed at Entry visit of the extension study, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, and end of study. Change from study AMB115811 Baseline in hemoglobin and MCHC is summarized. AMB115811 Baseline is the last value recorded on or prior to start of study treatment in that study. Change from AMB115811 Baseline was calculated as the value at the indicated visit minus the Baseline value. Participant's final visit in Study AMB115811 was used as the entry visit of this open-label extension study. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA indicates that data were not available. |
| 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) | Hematology parameters were assessed at Entry visit of the extension study, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, and end of study. Change from study AMB115811 Baseline in hematocrit is summarized. AMB115811 Baseline is the last value recorded on or prior to start of study treatment in that study. Change from AMB115811 Baseline was calculated as the value at the indicated visit minus the Baseline value. Participant's final visit in study AMB115811 was used as the entry visit of this open-label extension study. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA indicates that data were not available. |
| 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) | Hematology parameters were assessed at Entry visit of the extension study, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, and end of study. Change from study AMB115811 Baseline in mean corpuscle volume is summarized. AMB115811 Baseline is the last value recorded on or prior to start of study treatment in that study. Change from AMB115811 Baseline was calculated as the value at the indicated visit minus the Baseline value. Participant's final visit in study AMB115811 was used as the entry visit of this open-label extension study. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA indicates that data were not available. |
| 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) | Hematology parameters were assessed at Entry visit of the extension study, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, and end of study. Change from study AMB115811 Baseline in red blood cell count and reticulocytes is summarized. AMB115811 Baseline is the last value recorded on or prior to start of study treatment in that study. Change from AMB115811 Baseline was calculated as the value at the indicated visit minus the Baseline value. Participant's final visit in study AMB115811 was used as the entry visit of this open-label extension study. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA indicates that data were not available. |
| 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) | Blood samples were collected post Entry visit of the extension study and up to end of study for evaluation of the clinical chemistry parameters of alanine amino transferase (ALT), aspartate amino transferase (AST), gamma glutamyl transferase (GGT), and total bilirubin. The clinical chemistry parameters of potential clinical concern high were defined as follows: ALT, AST, GGT \>=3 times upper limit of normal (ULN); total bilirubin \>=2 times ULN. Participants with both normal and high values were counted once under their worst case (high). Participant's final visit in study AMB115811 was used as the entry visit of this open-label extension study. |
| 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) | Blood samples were collected at Entry visit of the extension study, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, and end of study plus any unscheduled lab tests for creatinine. A creatinine value of potential clinical concern high was defined as \>=176.8 micromoles per Liter. Participants with both normal and high values were counted once under their worst case (high). Participant's final visit in study AMB115811 was used as the entry visit of this open-label extension study. |
| 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) | Vital signs including SBP and DBP were assessed at Entry visit of the extension study, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, and end of study. Change from study AMB115811 Baseline in SBP and DBP is summarized. AMB115811 Baseline is the last value recorded on or prior to start of study treatment in that study. Change from AMB115811 Baseline was calculated as the value at the indicated visit minus the Baseline value. Participant's final visit in study AMB115811 was used as the entry visit of this open-label extension study. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA indicates that data were not available. |
| 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) | Vital signs including heart rate were assessed at Entry visit of the extension study, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, and end of study. Change from study AMB115811 Baseline in heart rate is summarized. AMB115811 Baseline is the last value recorded on or prior to start of study treatment in that study. Change from AMB115811 Baseline was calculated as the value at the indicated visit minus the Baseline value. Participant's final visit in study AMB115811 was used as the entry visit of this open-label extension study. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA indicates that data were not available |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
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 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 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group504
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 Any Adverse Event (AE) or Serious Adverse Event (SAE) | Previous Placebo | Any AE | 8 | Participants | |
| Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) | Previous Ambrisentan | Any AE | 6 | Participants | |
| Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) | Previous Placebo | Any SAE | 3 | Participants | |
| Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) | Previous Ambrisentan | Any SAE | 0 | Participants | |
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 | Previous Placebo | Basophils, Entry visit, n=9, 10 | -0.010 | Inter-Quartile Range -0.020 to 0.000 | Giga per Liter (GI/L) |
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 | Previous Ambrisentan | Basophils, Entry visit, n=9, 10 | 0.000 | Inter-Quartile Range -0.010 to 0.010 | Giga per Liter (GI/L) |
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 | Previous Placebo | Basophils, Month 1, n=7, 10 | -0.010 | Inter-Quartile Range -0.010 to 0.000 | Giga per Liter (GI/L) |
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 | Previous Ambrisentan | Basophils, Month 1, n=7, 10 | 0.000 | Inter-Quartile Range -0.020 to 0.000 | Giga per Liter (GI/L) |
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 | Previous Placebo | Basophils, Month 3, n=7, 8 | -0.010 | Inter-Quartile Range -0.020 to 0.010 | Giga per Liter (GI/L) |
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 | Previous Ambrisentan | Basophils, Month 3, n=7, 8 | 0.000 | Inter-Quartile Range -0.010 to 0.020 | Giga per Liter (GI/L) |
1 to 10 of 504Source ClinicalTrials.gov
See all 504 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Previous Placebo | 9 | |
| Overall Study | STARTED | Previous Ambrisentan | 10 | |
| Overall Study | COMPLETED | Previous Placebo | 0 | |
| Overall Study | COMPLETED | Previous Ambrisentan | 0 | |
| Overall Study | NOT COMPLETED | Previous Placebo | 9 | |
| Overall Study | NOT COMPLETED | Previous Ambrisentan | 10 |
Source ClinicalTrials.gov
Adverse events102
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 | Anaemia | Blood and lymphatic system disorders | Previous Placebo | 1 | 9 | |
| other | Anaemia | Blood and lymphatic system disorders | Previous Ambrisentan | 0 | 10 | |
| other | Cyanosis | Cardiac disorders | Previous Placebo | 1 | 9 | |
| other | Cyanosis | Cardiac disorders | Previous Ambrisentan | 0 | 10 | |
| other | Tachycardia | Cardiac disorders | Previous Placebo | 1 | 9 | |
| other | Tachycardia | Cardiac disorders | Previous Ambrisentan | 0 | 10 | |
| other | Diarrhoea | Gastrointestinal disorders | Previous Placebo | 2 | 9 | |
| other | Diarrhoea | Gastrointestinal disorders | Previous Ambrisentan | 1 | 10 | |
| other | Hiatus hernia | Gastrointestinal disorders | Previous Placebo | 1 | 9 | |
| other | Hiatus hernia | Gastrointestinal disorders | Previous Ambrisentan | 0 | 10 |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Previous Placebo | ||
| Total, all-cause mortality | Previous Ambrisentan | ||
| Total, other adverse events | Previous Placebo | 8 | 9 |
| Total, other adverse events | Previous Ambrisentan | 6 | 10 |
| Total, serious adverse events | Previous Placebo | 3 | 9 |
| Total, serious adverse events | Previous Ambrisentan | 0 | 10 |
Source ClinicalTrials.gov
Papers0
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Previous Ambrisentan vs Previous Placebo: Number of Participants With Creatinine Values of Potential Clinical Concern at Any Time Post Entry Visit | Trial comparisons |
| Previous Ambrisentan vs Previous Placebo: Number of Participants With Clinical Worsening of Chronic Thromboembolic Pulmonary Hypertension (CTEPH) | Trial comparisons |
| Previous Ambrisentan vs Previous Placebo: 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/NCT01894022
GET https://conductscience.org/api/trials/v1/NCT01894022/registered?page=2