Study of Ambrisentan in Participants With Pulmonary Hypertension (ABS-LT)

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ClinicalTrials.gov Identifier: NCT00777920

Recruitment Status : Completed

First Posted : October 22, 2008

Results First Posted : September 30, 2020

Last Update Posted : September 30, 2020

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Gilead Sciences

Study Type	Interventional
Study Design	Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Pulmonary Hypertension
Intervention	Drug: Ambrisentan
Enrollment	140

Participant Flow

Recruitment Details	Participants were enrolled at study sites in Argentina, Australia, Brazil, Canada, Chile, Mexico, Russia, Ukraine, and United States. The first participant was screened on 17 November 2008. The last study observation occurred on 11 September 2019.
Pre-assignment Details	140 participants were screened.


Arm/Group Title	Ambrisentan
Arm/Group Description	Participants received ambrisentan 2...
Arm/Group Description	Participants received ambrisentan 2.5 mg, 5 mg or 10 mg tablet orally once daily until such time as the investigator or participant chose to stop ambrisentan treatment, ambrisentan became commercially available, or the sponsor stopped the study.
Period Title: Overall Study
Started	140
Completed	90
Not Completed	50
Reason Not Completed
Adverse Event	39
Withdrawal of Consent	4
Lost to Follow-up	1
Investigator's discretion	1
Clinical status did not improve	1
Other, not specified	4

Baseline Characteristics

Arm/Group Title		Ambrisentan
Arm/Group Description		Participants received ambrisentan 2...
Arm/Group Description		Participants received ambrisentan 2.5 mg, 5 mg or 10 mg tablet orally once daily until such time as the investigator or participant chose to stop ambrisentan treatment, ambrisentan became commercially available, or the sponsor stopped the study.
Overall Number of Baseline Participants		140
Baseline Analysis Population Description		...
Baseline Analysis Population Description		The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	140 participants
		53 (15.9)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	140 participants
	Female	110
	Male	30
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	140 participants
	Hispanic or Latino	61
	Not Hispanic or Latino	79
	Unknown or Not Reported	0
Race/Ethnicity, Customized Measure Type: Count of Participants Unit of measure: Participants
Race	Number Analyzed	140 participants
	American Indian or Alaska Native	1
	Asian	4
	Black or African American	5
	White	126
	Other	4
Region of Enrollment Measure Type: Number Unit of measure: Participants	Number Analyzed	140 participants
Argentina		18
Australia		31
Brazil		19
Canada		2
Chile		13
Mexico		12
Russia		14
Ukraine		2
United States		29

Outcome Measures

1.Primary Outcome


Title	Percentage of Participants With Adverse Events (AEs) Associated With Long-Term Exposure to Ambrisentan
Description	[Not Specified]
Description	[Not Specified]
Time Frame	First dose date of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks)

Outcome Measure Data

Analysis Population Description

The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.


Arm/Group Title	Ambrisentan
Arm/Group Description:	Participants received ambrisentan 2...
Arm/Group Description:	Participants received ambrisentan 2.5 mg, 5 mg or 10 mg tablet orally once daily until such time as the investigator or participant chose to stop ambrisentan treatment, ambrisentan became commercially available, or the sponsor stopped the study.
Overall Number of Participants Analyzed	140
Measure Type: Number Unit of Measure: percentage of participants
	90.7

Adverse Events

Time Frame	Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
Adverse Event Reporting Description	The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.

Arm/Group Title	Ambrisentan
Arm/Group Description	Participants received ambrisentan 2...
Arm/Group Description	Participants received ambrisentan 2.5 mg, 5 mg or 10 mg tablet orally once daily until such time as the investigator or participant chose to stop ambrisentan treatment, ambrisentan became commercially available, or the sponsor stopped the study.
All-Cause Mortality
	Ambrisentan
	Affected / at Risk (%)
Total	39/140 (27.86%)
Serious Adverse Events Serious Adverse Events
	Ambrisentan
	Affected / at Risk (%)
Total	80/140 (57.14%)
Blood and lymphatic system disorders
Anaemia ^† 1	4/140 (2.86%)
Febrile neutropenia ^† 1	1/140 (0.71%)
Iron deficiency anaemia ^† 1	1/140 (0.71%)
Neutropenia ^† 1	1/140 (0.71%)
Pancytopenia ^† 1	1/140 (0.71%)
Cardiac disorders
Atrial fibrillation ^† 1	6/140 (4.29%)
Atrial flutter ^† 1	4/140 (2.86%)
Bradycardia ^† 1	1/140 (0.71%)
Cardiac arrest ^† 1	3/140 (2.14%)
Cardiac failure ^† 1	1/140 (0.71%)
Cardiac failure congestive ^† 1	5/140 (3.57%)
Cardiogenic shock ^† 1	2/140 (1.43%)
Cardiopulmonary failure ^† 1	2/140 (1.43%)
Cor pulmonale ^† 1	1/140 (0.71%)
Myocardial infarction ^† 1	2/140 (1.43%)
Palpitations ^† 1	1/140 (0.71%)
Pericardial effusion ^† 1	1/140 (0.71%)
Pericarditis ^† 1	1/140 (0.71%)
Right ventricular dysfunction ^† 1	1/140 (0.71%)
Right ventricular failure ^† 1	13/140 (9.29%)
Ear and labyrinth disorders
Deafness unilateral ^† 1	1/140 (0.71%)
Hypoacusis ^† 1	1/140 (0.71%)
Gastrointestinal disorders
Ascites ^† 1	1/140 (0.71%)
Gastrointestinal haemorrhage ^† 1	1/140 (0.71%)
Gastrooesophageal reflux disease ^† 1	1/140 (0.71%)
Incarcerated umbilical hernia ^† 1	1/140 (0.71%)
Inguinal hernia ^† 1	1/140 (0.71%)
Intestinal ischaemia ^† 1	1/140 (0.71%)
Intra-abdominal haemorrhage ^† 1	2/140 (1.43%)
Small intestinal obstruction ^† 1	1/140 (0.71%)
General disorders
Chest discomfort ^† 1	1/140 (0.71%)
Chest pain ^† 1	1/140 (0.71%)
Multiple organ dysfunction syndrome ^† 1	1/140 (0.71%)
Pyrexia ^† 1	3/140 (2.14%)
Strangulated hernia ^† 1	1/140 (0.71%)
Sudden death ^† 1	1/140 (0.71%)
Hepatobiliary disorders
Cholecystitis ^† 1	1/140 (0.71%)
Infections and infestations
Abdominal infection ^† 1	1/140 (0.71%)
Appendicitis ^† 1	1/140 (0.71%)
Breast cellulitis ^† 1	1/140 (0.71%)
Cellulitis ^† 1	1/140 (0.71%)
Dengue fever ^† 1	1/140 (0.71%)
Device related infection ^† 1	1/140 (0.71%)
Device related sepsis ^† 1	1/140 (0.71%)
Infected fistula ^† 1	1/140 (0.71%)
Infection ^† 1	1/140 (0.71%)
Infective exacerbation of chronic obstructive airways disease ^† 1	1/140 (0.71%)
Lower respiratory tract infection ^† 1	3/140 (2.14%)
Pertussis ^† 1	1/140 (0.71%)
Pneumonia ^† 1	12/140 (8.57%)
Respiratory tract infection ^† 1	2/140 (1.43%)
Salmonellosis ^† 1	1/140 (0.71%)
Sepsis ^† 1	4/140 (2.86%)
Streptococcal sepsis ^† 1	1/140 (0.71%)
Tracheobronchitis ^† 1	1/140 (0.71%)
Upper respiratory tract infection ^† 1	1/140 (0.71%)
Urinary tract infection ^† 1	1/140 (0.71%)
Vascular device infection ^† 1	2/140 (1.43%)
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis ^† 1	1/140 (0.71%)
Burns first degree ^† 1	1/140 (0.71%)
Foot fracture ^† 1	1/140 (0.71%)
Post procedural haematoma ^† 1	1/140 (0.71%)
Subdural haematoma ^† 1	1/140 (0.71%)
Investigations
Alanine aminotransferase increased ^† 1	2/140 (1.43%)
Aspartate aminotransferase increased ^† 1	2/140 (1.43%)
International normalised ratio increased ^† 1	1/140 (0.71%)
Liver function test increased ^† 1	1/140 (0.71%)
Platelet count decreased ^† 1	1/140 (0.71%)
Staphylococcus test positive ^† 1	1/140 (0.71%)
Metabolism and nutrition disorders
Fluid overload ^† 1	1/140 (0.71%)
Fluid retention ^† 1	2/140 (1.43%)
Gout ^† 1	1/140 (0.71%)
Hyperkalaemia ^† 1	1/140 (0.71%)
Hypokalaemia ^† 1	1/140 (0.71%)
Hyponatraemia ^† 1	1/140 (0.71%)
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	1/140 (0.71%)
Haematoma muscle ^† 1	1/140 (0.71%)
Muscular weakness ^† 1	1/140 (0.71%)
Osteoarthritis ^† 1	1/140 (0.71%)
Osteonecrosis ^† 1	1/140 (0.71%)
Pain in extremity ^† 1	1/140 (0.71%)
Systemic lupus erythematosus ^† 1	1/140 (0.71%)
Tenosynovitis ^† 1	1/140 (0.71%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer ^† 1	1/140 (0.71%)
Cervix carcinoma stage III ^† 1	1/140 (0.71%)
Colon cancer ^† 1	1/140 (0.71%)
Hepatic cancer ^† 1	1/140 (0.71%)
Intraductal proliferative breast lesion ^† 1	1/140 (0.71%)
Neuroendocrine carcinoma ^† 1	1/140 (0.71%)
Oesophageal carcinoma ^† 1	1/140 (0.71%)
Rectal adenoma ^† 1	1/140 (0.71%)
Squamous cell carcinoma ^† 1	1/140 (0.71%)
Uterine leiomyoma ^† 1	1/140 (0.71%)
Nervous system disorders
Carotid artery occlusion ^† 1	1/140 (0.71%)
Cerebrovascular accident ^† 1	2/140 (1.43%)
Dizziness ^† 1	1/140 (0.71%)
Headache ^† 1	1/140 (0.71%)
Sciatica ^† 1	1/140 (0.71%)
Syncope ^† 1	3/140 (2.14%)
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous ^† 1	1/140 (0.71%)
Product Issues
Device dislocation ^† 1	1/140 (0.71%)
Device malfunction ^† 1	1/140 (0.71%)
Renal and urinary disorders
Acute kidney injury ^† 1	1/140 (0.71%)
Chronic kidney disease ^† 1	2/140 (1.43%)
Renal impairment ^† 1	1/140 (0.71%)
Urinary bladder polyp ^† 1	1/140 (0.71%)
Reproductive system and breast disorders
Benign prostatic hyperplasia ^† 1	1/140 (0.71%)
Endometriosis ^† 1	1/140 (0.71%)
Menorrhagia ^† 1	1/140 (0.71%)
Metrorrhagia ^† 1	1/140 (0.71%)
Ovarian cyst ^† 1	1/140 (0.71%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure ^† 1	2/140 (1.43%)
Chronic obstructive pulmonary disease ^† 1	6/140 (4.29%)
Dyspnoea ^† 1	3/140 (2.14%)
Dyspnoea exertional ^† 1	1/140 (0.71%)
Epistaxis ^† 1	1/140 (0.71%)
Haemoptysis ^† 1	4/140 (2.86%)
Hypoxia ^† 1	3/140 (2.14%)
Pleural effusion ^† 1	1/140 (0.71%)
Pneumothorax ^† 1	1/140 (0.71%)
Pneumothorax spontaneous ^† 1	1/140 (0.71%)
Productive cough ^† 1	1/140 (0.71%)
Pulmonary arterial hypertension ^† 1	5/140 (3.57%)
Pulmonary fibrosis ^† 1	4/140 (2.86%)
Pulmonary hypertension ^† 1	12/140 (8.57%)
Respiratory failure ^† 1	4/140 (2.86%)
Skin and subcutaneous tissue disorders
Skin ulcer ^† 1	1/140 (0.71%)
Vascular disorders
Aortic stenosis ^† 1	1/140 (0.71%)
Haematoma ^† 1	1/140 (0.71%)
Hypotension ^† 1	3/140 (2.14%)
Peripheral artery occlusion ^† 1	1/140 (0.71%)
Peripheral artery thrombosis ^† 1	1/140 (0.71%)
Peripheral ischaemia ^† 1	2/140 (1.43%)
Venous thrombosis limb ^† 1	1/140 (0.71%)
1 Term from vocabulary, MedDRA 23.0 † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Ambrisentan
	Affected / at Risk (%)
Total	112/140 (80.00%)
Blood and lymphatic system disorders
Anaemia ^† 1	12/140 (8.57%)
Iron deficiency anaemia ^† 1	11/140 (7.86%)
Cardiac disorders
Atrial fibrillation ^† 1	9/140 (6.43%)
Palpitations ^† 1	19/140 (13.57%)
Right ventricular failure ^† 1	7/140 (5.00%)
Endocrine disorders
Hypothyroidism ^† 1	8/140 (5.71%)
Eye disorders
Cataract ^† 1	7/140 (5.00%)
Gastrointestinal disorders
Abdominal pain ^† 1	8/140 (5.71%)
Constipation ^† 1	9/140 (6.43%)
Diarrhoea ^† 1	16/140 (11.43%)
Gastrooesophageal reflux disease ^† 1	13/140 (9.29%)
Nausea ^† 1	13/140 (9.29%)
Vomiting ^† 1	9/140 (6.43%)
General disorders
Chest pain ^† 1	9/140 (6.43%)
Fatigue ^† 1	16/140 (11.43%)
Oedema peripheral ^† 1	41/140 (29.29%)
Infections and infestations
Bronchitis ^† 1	7/140 (5.00%)
Cellulitis ^† 1	7/140 (5.00%)
Lower respiratory tract infection ^† 1	7/140 (5.00%)
Pharyngitis ^† 1	10/140 (7.14%)
Pneumonia ^† 1	7/140 (5.00%)
Respiratory tract infection ^† 1	9/140 (6.43%)
Sinusitis ^† 1	13/140 (9.29%)
Upper respiratory tract infection ^† 1	32/140 (22.86%)
Urinary tract infection ^† 1	12/140 (8.57%)
Investigations
Blood creatinine increased ^† 1	7/140 (5.00%)
Gamma-glutamyltransferase increased ^† 1	10/140 (7.14%)
Heart sounds abnormal ^† 1	10/140 (7.14%)
International normalised ratio increased ^† 1	7/140 (5.00%)
Metabolism and nutrition disorders
Gout ^† 1	7/140 (5.00%)
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	12/140 (8.57%)
Back pain ^† 1	9/140 (6.43%)
Pain in extremity ^† 1	9/140 (6.43%)
Nervous system disorders
Dizziness ^† 1	19/140 (13.57%)
Headache ^† 1	25/140 (17.86%)
Syncope ^† 1	8/140 (5.71%)
Psychiatric disorders
Anxiety ^† 1	12/140 (8.57%)
Depression ^† 1	15/140 (10.71%)
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	15/140 (10.71%)
Dyspnoea ^† 1	26/140 (18.57%)
Dyspnoea exertional ^† 1	7/140 (5.00%)
Epistaxis ^† 1	8/140 (5.71%)
Nasal congestion ^† 1	14/140 (10.00%)
1 Term from vocabulary, MedDRA 23.0 † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
The study has been completed at all study sites for at least 2 years

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Gilead Clinical Study Information Center
Organization:	Gilead Sciences
Phone:	1-833-445-3230 (GILEAD-0)
EMail:	GileadClinicalTrials@gilead.com

Layout table for additonal information

Responsible Party:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT00777920
Other Study ID Numbers:	GS-US-300-0124
First Submitted:	July 1, 2008
First Posted:	October 22, 2008
Results First Submitted:	September 8, 2020
Results First Posted:	September 30, 2020
Last Update Posted:	September 30, 2020

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