NCT01894022 (AMBER II) is a Phase 3 clinical trial of Ambrisentan 5 mg in Hypertension, sponsored by GlaxoSmithKline.

Who is sponsoring NCT01894022?

NCT01894022 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT01894022?

Interventions in NCT01894022: Ambrisentan 5 mg.

What condition does NCT01894022 study?

NCT01894022 studies Hypertension.

Is NCT01894022 still recruiting?

NCT01894022 is currently terminated. Last updated 11 September 2017.

Are results published for NCT01894022?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-09-11 · How we verify

NCT01894022: AMBER II

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Open Label Study to Assess the Long-term Safety, Tolerability and Efficacy of Ambrisentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

Terminated Phase 3 Results posted Last updated 11 September 2017

What this trial tests

Phase 3 trial testing Ambrisentan 5 mg in Hypertension in 19 participants. Terminated before completion.

Timeline

23 January 2014

Primary endpoint
18 November 2015

18 November 2015

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	19
Start date	23 January 2014
Primary completion	18 November 2015
Estimated completion	18 November 2015
Sites	50 locations across Japan, Netherlands, Russia, Austria, Saudi Arabia, United Kingdom, Germany, Israel

Drugs / interventions tested

Ambrisentan 5 mg — full drug profile →

Conditions studied

Hypertension — all drugs for Hypertension →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 80, any sex, with Hypertension. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) Primary · 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 en

Any AE

Group	Value	95% CI
Previous Placebo	8
Previous Ambrisentan	6

Any SAE

Group	Value	95% CI
Previous Placebo	3
Previous Ambrisentan	0

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 Primary · 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 op

Basophils, Entry visit, n=9, 10

Group	Value	95% CI
Previous Placebo	-0.010	-0.020 – 0.000
Previous Ambrisentan	0.000	-0.010 – 0.010

Basophils, Month 1, n=7, 10

Group	Value	95% CI
Previous Placebo	-0.010	-0.010 – 0.000
Previous Ambrisentan	0.000	-0.020 – 0.000

Basophils, Month 3, n=7, 8

Group	Value	95% CI
Previous Placebo	-0.010	-0.020 – 0.010
Previous Ambrisentan	0.000	-0.010 – 0.020

Basophils, Month 6, n=5, 6

Group	Value	95% CI
Previous Placebo	0.000	-0.020 – 0.000
Previous Ambrisentan	0.000	-0.010 – 0.030

Basophils, Month 9, n=2, 5

Group	Value	95% CI
Previous Placebo	-0.025	-0.040 – -0.010
Previous Ambrisentan	-0.010	-0.020 – -0.010

Basophils, Month 12, n=1, 3

Group	Value	95% CI
Previous Placebo	-0.020	-0.020 – -0.020
Previous Ambrisentan	0.000	-0.020 – 0.010

Basophils, Month 15, n=0, 1

Group	Value	95% CI
Previous Placebo	NA	NA – NA
Previous Ambrisentan	-0.010	-0.010 – -0.010

Basophils, End of study, n=8, 9

Group	Value	95% CI
Previous Placebo	-0.005	-0.025 – 0.015
Previous Ambrisentan	0.000	0.000 – 0.000

Change From Study AMB115811 Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at the Indicated Time Points Primary · 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 po

Hemoglobin, Entry visit, n=9, 10

Group	Value	95% CI
Previous Placebo	-5.0	-10 – 2
Previous Ambrisentan	-5.5	-9 – -3

Hemoglobin, Month 1, n=7, 10

Group	Value	95% CI
Previous Placebo	-3.0	-7 – 1
Previous Ambrisentan	-6.5	-9 – -4

Hemoglobin, Month 3, n=7, 8

Group	Value	95% CI
Previous Placebo	-7.0	-25.0 – 8.0
Previous Ambrisentan	-10.5	-14.5 – -1.0

Hemoglobin, Month 6, n=5, 6

Group	Value	95% CI
Previous Placebo	-10.0	-18.0 – 0.0
Previous Ambrisentan	-6.5	-12.0 – -3.0

Hemoglobin, Month 9, n=2, 5

Group	Value	95% CI
Previous Placebo	-25.0	-31.0 – -19.0
Previous Ambrisentan	-6.0	-6.0 – -4.0

Hemoglobin, Month 12, n=1, 3

Group	Value	95% CI
Previous Placebo	21.0	21.0 – 21.0
Previous Ambrisentan	-6.0	-9.0 – -2.0

Hemoglobin, Month 15, n=0, 1

Group	Value	95% CI
Previous Placebo	NA	NA – NA
Previous Ambrisentan	-11.0	-11.0 – -11.0

Hemoglobin, End of study, n=8, 9

Group	Value	95% CI
Previous Placebo	-10.0	-15.5 – -2.0
Previous Ambrisentan	-8.0	-11.0 – -2.0

Change From Study AMB115811 Baseline in Hematocrit at the Indicated Time Points Primary · 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

Hematocrit, Entry visit, n=9, 10

Group	Value	95% CI
Previous Placebo	-0.007	-0.031 – 0.004
Previous Ambrisentan	-0.018	-0.043 – -0.005

Hematocrit, Month 1, n=7, 10

Group	Value	95% CI
Previous Placebo	-0.018	-0.028 – 0.011
Previous Ambrisentan	-0.024	-0.035 – -0.005

Hematocrit, Month 3, n=7, 8

Group	Value	95% CI
Previous Placebo	-0.027	-0.084 – 0.023
Previous Ambrisentan	-0.034	-0.052 – -0.006

Hematocrit, Month 6, n=5, 6

Group	Value	95% CI
Previous Placebo	-0.033	-0.057 – 0.005
Previous Ambrisentan	-0.019	-0.030 – -0.012

Hematocrit, Month 9, n=2, 5

Group	Value	95% CI
Previous Placebo	-0.083	-0.107 – -0.058
Previous Ambrisentan	-0.016	-0.021 – -0.011

Hematocrit, Month 12, n=1, 3

Group	Value	95% CI
Previous Placebo	0.058	0.058 – 0.058
Previous Ambrisentan	-0.009	-0.036 – 0.001

Hematocrit, Month 15, n=0, 1

Group	Value	95% CI
Previous Placebo	NA	NA – NA
Previous Ambrisentan	-0.034	-0.034 – -0.034

Hematocrit, End of study, n=8, 9

Group	Value	95% CI
Previous Placebo	-0.033	-0.049 – 0.004
Previous Ambrisentan	-0.015	-0.024 – -0.001

Change From Study AMB115811 Baseline in Mean Corpuscle Volume at the Indicated Time Points Primary · 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

Mean corpuscle volume, Entry visit, n=9, 10

Group	Value	95% CI
Previous Placebo	-2.0	-4.0 – -1.0
Ambrisentan 5 mg	-0.5	-2.0 – 0.0

Mean corpuscle volume, Month 1, n=7, 10

Group	Value	95% CI
Previous Placebo	-2.0	-4.0 – 1.0
Ambrisentan 5 mg	-0.5	-3.0 – 1.0

Mean corpuscle volume, Month 3, n=7, 8

Group	Value	95% CI
Previous Placebo	-2.0	-6.0 – 1.0
Ambrisentan 5 mg	-1.0	-4.0 – -0.5

Mean corpuscle volume, Month 6, n=5, 6

Group	Value	95% CI
Previous Placebo	-3.0	-3.0 – 0.0
Ambrisentan 5 mg	-0.5	-2.0 – 0.0

Mean corpuscle volume, Month 9, n=2, 5

Group	Value	95% CI
Previous Placebo	-7.0	-11.0 – -3.0
Ambrisentan 5 mg	0.0	0.0 – 1.0

Mean corpuscle volume, Month 12, n=1, 3

Group	Value	95% CI
Previous Placebo	-2.0	-2.0 – -2.0
Ambrisentan 5 mg	2.0	-1.0 – 2.0

Mean corpuscle volume, Month 15, n=0, 1

Group	Value	95% CI
Previous Placebo	NA	NA – NA
Ambrisentan 5 mg	1.0	1.0 – 1.0

Mean corpuscle volume, End of study, n=8, 9

Group	Value	95% CI
Previous Placebo	-2.5	-3.5 – 0.5
Ambrisentan 5 mg	0.0	0.0 – 2.0

Change From Study AMB115811 Baseline in Red Blood Cell Count and Reticulocytes at the Indicated Time Points Primary · 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 th

Red blood cell count, Entry visit , n=9, 10

Group	Value	95% CI
Previous Placebo	-0.20	-0.30 – 0.20
Previous Ambrisentan	-0.15	-0.40 – -0.10

Red blood cell count, Month 1, n=7, 10

Group	Value	95% CI
Previous Placebo	0.00	-0.50 – 0.20
Previous Ambrisentan	-0.25	-0.30 – -0.10

Red blood cell count, Month 3, n=7, 8

Group	Value	95% CI
Previous Placebo	0.00	-0.70 – 0.40
Previous Ambrisentan	-0.25	-0.45 – -0.05

Red blood cell count, Month 6, n=5, 6

Group	Value	95% CI
Previous Placebo	-0.30	-0.70 – 0.10
Previous Ambrisentan	-0.15	-0.30 – 0.00

Red blood cell count, Month 9, n=2, 5

Group	Value	95% CI
Previous Placebo	-0.55	-0.60 – -0.50
Previous Ambrisentan	-0.20	-0.20 – -0.10

Red blood cell count, Month 12, n=1, 3

Group	Value	95% CI
Previous Placebo	0.70	0.70 – 0.70
Previous Ambrisentan	-0.20	-0.30 – -0.10

Red blood cell count, Month 15, n=0, 1

Group	Value	95% CI
Previous Placebo	NA	NA – NA
Previous Ambrisentan	-0.40	-0.40 – -0.40

Red blood cell count, End of study, n=8, 9

Group	Value	95% CI
Previous Placebo	-0.15	-0.40 – 0.00
Previous Ambrisentan	-0.20	-0.40 – 0.10

Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern at Any Time Post Entry Visit Primary · 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 a

ALT, >clinical concern high

Group	Value	95% CI
Previous Placebo	0
Previous Ambrisentan	0

AST, >clinical concern high

Group	Value	95% CI
Previous Placebo	0
Previous Ambrisentan	0

GGT, >clinical concern high

Group	Value	95% CI
Previous Placebo	1
Previous Ambrisentan	0

Total bilirubin, >clinical concern high

Group	Value	95% CI
Previous Placebo	0
Previous Ambrisentan	0

Number of Participants With Creatinine Values of Potential Clinical Concern at Any Time Post Entry Visit Primary · 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.

Group	Value	95% CI
Previous Placebo	1
Previous Ambrisentan	0

Change From Study AMB115811 Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Assessed at the Indicated Time Points Primary · 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 tim

Systolic blood pressure, Entry visit, n=9, 10

Group	Value	95% CI
Previous Placebo	-6.0	-11.0 – 3.0
Previous Ambrisentan	-3.0	-8.0 – 11.0

Systolic blood pressure, Month 1, n=8, 10

Group	Value	95% CI
Previous Placebo	-0.5	-21.0 – 4.5
Previous Ambrisentan	-5.5	-7.0 – 3.0

Systolic blood pressure, Month 3, n=8, 8

Group	Value	95% CI
Previous Placebo	-4.0	-13.5 – 14.5
Previous Ambrisentan	-4.0	-8.0 – 0.0

Systolic blood pressure, Month 6, n=5, 6

Group	Value	95% CI
Previous Placebo	-10.0	-30.0 – -9.0
Previous Ambrisentan	-5.0	-14.0 – 0.0

Systolic blood pressure, Month 9, n=3, 5

Group	Value	95% CI
Previous Placebo	-1.0	-14.0 – 14.0
Previous Ambrisentan	-2.0	-6.0 – 4.0

Systolic blood pressure, Month 12, n=1, 4

Group	Value	95% CI
Previous Placebo	15.0	15.0 – 15.0
Previous Ambrisentan	-8.5	-15.5 – 6.5

Systolic blood pressure, Month 15, n=0, 1

Group	Value	95% CI
Previous Placebo	NA	NA – NA
Previous Ambrisentan	-2.0	-2.0 – -2.0

Systolic blood pressure, End of study, n=8, 10

Group	Value	95% CI
Previous Placebo	2.5	-14.0 – 12.5
Previous Ambrisentan	1.0	-5.0 – 5.0

Change From Study AMB115811 Baseline in Heart Rate at the Indicated Time Points Primary · 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

Heart rate, Entry visit, n=9, 10

Group	Value	95% CI
Previous Placebo	-2.0	-17.0 – 5.0
Previous Ambrisentan	-7.0	-17.0 – 1.0

Heart rate, Month 1, n=8, 10

Group	Value	95% CI
Previous Placebo	-12.0	-19.5 – 4.0
Previous Ambrisentan	-2.0	-7.0 – 3.0

Heart rate, Month 3, n=8, 8

Group	Value	95% CI
Previous Placebo	-8.5	-19.0 – 1.5
Previous Ambrisentan	-1.0	-11.0 – 4.5

Heart rate, Month 6, n=5, 6

Group	Value	95% CI
Previous Placebo	-19.0	-24.0 – -14.0
Previous Ambrisentan	-3.5	-6.0 – -1.0

Heart rate, Month 9, n=3, 5

Group	Value	95% CI
Previous Placebo	-12.0	-12.0 – -11.0
Previous Ambrisentan	-6.0	-7.0 – -2.0

Heart rate, Month 12, n=1, 4

Group	Value	95% CI
Previous Placebo	-12.0	-12.0 – -12.0
Previous Ambrisentan	-12.5	-16.5 – -4.5

Heart rate, Month 15, n=0, 1

Group	Value	95% CI
Previous Placebo	NA	NA – NA
Previous Ambrisentan	-11.0	-11.0 – -11.0

Heart rate, End of study, n=8, 10

Group	Value	95% CI
Previous Placebo	-10.5	-15.0 – 1.0
Previous Ambrisentan	0.5	-5.0 – 4.0

Change From Study AMB115811 Baseline in Weight at the Indicated Time Points Primary · 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)

Weight was measured at Entry visit of the extension study, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, and at end of study. Change from study AMB115811 Baseline in weight 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 (repres

Weight, Entry visit, n=9, 10

Group	Value	95% CI
Previous Placebo	-1.00	-1.50 – 1.40
Previous Ambrisentan	-1.00	-2.80 – 0.50

Weight, Month 1, n=8, 10

Group	Value	95% CI
Previous Placebo	0.00	-1.50 – 0.60
Previous Ambrisentan	-0.50	-2.20 – 0.50

Weight, Month 3, n=8, 8

Group	Value	95% CI
Previous Placebo	-0.50	-2.00 – 0.55
Previous Ambrisentan	-2.00	-4.45 – 0.50

Weight, Month 6, n=5, 6

Group	Value	95% CI
Previous Placebo	0.00	-10.00 – 1.10
Previous Ambrisentan	-3.10	-5.00 – -0.50

Weight, Month 9, n=3, 5

Group	Value	95% CI
Previous Placebo	0.00	-19.70 – 1.60
Previous Ambrisentan	-3.50	-5.50 – 1.00

Weight, Month 12, n=1, 4

Group	Value	95% CI
Previous Placebo	0.00	0.00 – 0.00
Previous Ambrisentan	-1.15	-3.25 – 1.00

Weight, Month 15, n=0, 1

Group	Value	95% CI
Previous Placebo	NA	NA – NA
Previous Ambrisentan	-2.50	-2.50 – -2.50

Weight, End of study, n=8, 10

Group	Value	95% CI
Previous Placebo	0.00	-1.00 – 0.85
Previous Ambrisentan	-0.05	-2.00 – 1.80

Change From Study AMB115811 Baseline in the 6 Minutes Walking Distance (6MWD) at the Indicated Time Points Secondary · 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)

The 6-minute walk test was conducted according to the American Thoracic Society guidelines in accordance with local standard operating procedures. 6MWD was measured by a 6-minute walk test. This test measures the distance that a par. can walk in a period of 6 minutes. AMB115811 Baseline was the Week 0 value in that study. Change from study AMB115811 Baseline was calculated as the value at the indicated visit minus the Baseline value. Par.'s final visit in study AMB115811 was used as the entry visit of this extension study. For the Extension study, the visit schedule (Months 1, 3, 6, 9, 12 and

(AMB115811) Month 1, n=15, 17

Group	Value	95% CI
Previous Placebo	5.00	-1.50 – 16.50
Previous Ambrisentan	14.00	1.00 – 42.50

Month 2, n=14, 16

Group	Value	95% CI
Previous Placebo	7.50	-14.50 – 22.50
Previous Ambrisentan	26.25	3.25 – 61.25

Month 3, n=13, 15

Group	Value	95% CI
Previous Placebo	5.50	-23.00 – 39.50
Previous Ambrisentan	20.50	4.00 – 68.00

Month 4, n=13, 15

Group	Value	95% CI
Previous Placebo	-10.00	-32.50 – 20.00
Previous Ambrisentan	25.00	12.00 – 49.00

EW (AMB115811) visit, n=3, 2

Group	Value	95% CI
Previous Placebo	7.50	-46.50 – 43.50
Previous Ambrisentan	41.25	0.00 – 82.50

(Extension study) Month 5, n=7, 9

Group	Value	95% CI
Previous Placebo	0.00	-15.50 – 40.00
Previous Ambrisentan	51.50	19.00 – 80.50

Month 7, n=7, 8

Group	Value	95% CI
Previous Placebo	-8.00	-22.50 – 55.00
Previous Ambrisentan	57.50	23.50 – 88.75

Month 10, n=5, 6

Group	Value	95% CI
Previous Placebo	55.00	-10.50 – 65.00
Previous Ambrisentan	52.25	21.00 – 100.00

Adverse events — posted to ClinicalTrials.gov

Time frame: Treatment-emergent adverse events (TEAEs) will include AEs up to 30 days after their last dose, assessed up to approximately 16 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Previous Placebo

Serious: 3/9 (33%)

Deaths: —

Previous Ambrisentan

Serious: 0/10 (0%)

Deaths: —

Serious adverse events (12 terms)

Reaction	System	Previous Placebo	Previous Ambrisentan
Cardiac failure	Cardiac disorders	—	—
Atrial fibrillation	Cardiac disorders	—	—
Bradyarrhythmia	Cardiac disorders	—	—
Right ventricular failure	Cardiac disorders	—	—
Ventricular tachycardia	Cardiac disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Implant site extravasation	General disorders	—	—
Oedema peripheral	General disorders	—	—
Gastroenteritis	Infections and infestations	—	—
Electrocardiogram repolarisation abnormality	Investigations	—	—
Oxygen saturation decreased	Investigations	—	—
Aortic stenosis	Vascular disorders	—	—

Other adverse events (39 terms — click to expand)

Reaction	System	Previous Placebo	Previous Ambrisentan
Oedema peripheral	General disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Nasopharyngitis	Infections and infestations	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Cyanosis	Cardiac disorders	—	—
Tachycardia	Cardiac disorders	—	—
Hiatus hernia	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Asthenia	General disorders	—	—
Fatigue	General disorders	—	—
Hyperthermia	General disorders	—	—
Influenza like illness	General disorders	—	—
Non-cardiac chest pain	General disorders	—	—
Oedema	General disorders	—	—
Bacteriuria	Infections and infestations	—	—
Bronchitis bacterial	Infections and infestations	—	—
Erysipelas	Infections and infestations	—	—
Respiratory tract infection	Infections and infestations	—	—
Tonsillitis	Infections and infestations	—	—
Tracheitis	Infections and infestations	—	—
Foot fracture	Injury, poisoning and procedural complications	—	—
Alanine aminotransferase increased	Investigations	—	—
Aspartate aminotransferase increased	Investigations	—	—
Blood creatinine increased	Investigations	—	—
Blood potassium decreased	Investigations	—	—
Iron deficiency	Metabolism and nutrition disorders	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Tendonitis	Musculoskeletal and connective tissue disorders	—	—
Dizziness	Nervous system disorders	—	—
Headache	Nervous system disorders	—	—
Migraine	Nervous system disorders	—	—
Renal failure	Renal and urinary disorders	—	—
Renal impairment	Renal and urinary disorders	—	—
Asthma	Respiratory, thoracic and mediastinal disorders	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—
Haemoptysis	Respiratory, thoracic and mediastinal disorders	—	—
Productive cough	Respiratory, thoracic and mediastinal disorders	—	—

Most-reported serious reactions: Cardiac failure, Atrial fibrillation, Bradyarrhythmia, Right ventricular failure, Ventricular tachycardia, Vomiting, Implant site extravasation, Oedema peripheral.

Data from ClinicalTrials.gov NCT01894022 adverse events section.

Sponsor's own description

This is an open label, long term extension to Study AMB115811. All subjects may remain in the extension study for a minimum of 18 months. Beyond the 18-month period, subjects may continue in the extension study until one of the following: the product is approved locally for use in inoperable CTEPH patients; development for use in the CTEPH population is discontinued or product is not approved by the local regulatory authorities; or the investigator decides to discontinue the subject or subject decides to discontinue from the study. The primary purpose of this study is to provide clinically relevant information on the long term safety of ambrisentan in subjects with inoperable CTEPH.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Medical management of chronic thromboembolic pulmonary hypertension.
Pepke-Zaba J, Ghofrani HA, Hoeper MM. · · 2017 · cited 45× · PMID 28356404 · DOI 10.1183/16000617.0107-2016
Ambrisentan for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH).
Escribano-Subias P, Bendjenana H, Curtis PS, Lang I, et al · · 2019 · cited 19× · PMID 30957635 · DOI 10.1177/2045894019846433

Verify or expand the search:

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Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01894022 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 11 September 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01894022.

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