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Trial record 9 of 179 for:    DCLRE1C

(ARTEMIS-IPF) Randomized, Placebo-Controlled Study to Evaluate Safety and Effectiveness of Ambrisentan in IPF (ARTEMIS-IPF)

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ClinicalTrials.gov Identifier: NCT00768300
Recruitment Status : Terminated (Lack of efficacy)
First Posted : October 8, 2008
Results First Posted : April 8, 2014
Last Update Posted : April 8, 2014
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Idiopathic Pulmonary Fibrosis
Interventions Drug: Ambrisentan
Drug: Placebo
Enrollment 494
Recruitment Details Participants were enrolled in a total of 136 study sites in North and South America, Europe, and Australia. The first participant was screened on 10 December 2008. The last participant observation was on 28 February 2011.
Pre-assignment Details 494 participants were randomized; 492 participants were treated, and comprise the Safety Analysis Set and the Full Analysis Set.
Arm/Group Title Ambrisentan Placebo
Hide Arm/Group Description Ambrisentan (5 mg or 10 mg tablet) administered orally once daily Placebo to match ambrisentan administered orally once daily
Period Title: Overall Study
Started 330 164
Randomized and Treated 329 163
Completed 1 1
Not Completed 329 163
Reason Not Completed
Randomized but not treated             1             1
Adverse Event             10             2
Protocol Violation             6             1
Withdrawal by Subject             13             7
Physician Decision             2             3
Study discontinued by Sponsor             271             140
Death             21             5
Subject moved to pursue lung transplant             1             1
Screen failure following randomization             1             0
Received lung transplant             1             1
Lost to Follow-up             0             1
Began prohibited concomitant medication             0             1
Treated but never dosed with Study drug             1             0
Missing data             1             0
Arm/Group Title Ambrisentan Placebo Total
Hide Arm/Group Description Ambrisentan (5 mg or 10 mg tablet) administered orally once daily Placebo to match ambrisentan administered orally once daily Total of all reporting groups
Overall Number of Baseline Participants 329 163 492
Hide Baseline Analysis Population Description
Full Analysis Set: participants who were randomized and treated
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 329 participants 163 participants 492 participants
65.8  (7.4) 66.1  (7.1) 65.9  (7.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 329 participants 163 participants 492 participants
Female
85
  25.8%
52
  31.9%
137
  27.8%
Male
244
  74.2%
111
  68.1%
355
  72.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 329 participants 163 participants 492 participants
Black or African Heritage 1 0 1
White 293 145 438
Asian 4 1 5
American Indian or Alaskan Native 1 1 2
Other 27 16 43
Not Permitted 3 0 3
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 329 participants 163 participants 492 participants
United States 141 62 203
Canada 25 14 39
Australia 22 12 34
France 21 10 31
Germany 17 9 26
Brazil 18 6 24
Peru 12 6 18
Czech Republic 10 6 16
Israel 8 7 15
Italy 11 3 14
Belgium 7 6 13
Colombia 8 3 11
Mexico 5 4 9
United Kingdom 3 6 9
Spain 7 1 8
Poland 3 3 6
Switzerland 5 1 6
Austria 2 2 4
Chile 3 1 4
Argentina 1 2 3
Ireland 1 0 1
[1]
Measure Description: All participants who were randomized are presented in Region of Enrollment (ambrisentan = 330; placebo = 164)
Baseline Pulmonary Hypertension (PH) per interactive voice response system (IVRS)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 329 participants 163 participants 492 participants
No 293 145 438
Yes 36 18 54
Smoking status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 329 participants 163 participants 492 participants
Never 105 53 158
Current 7 5 12
Former 217 104 321
[1]
Measure Description: Smoking status data is missing for one participant randomized to placebo.
Surgical lung biopsy (SLB) to Confirm Diagnosis of IPF (per IVRS)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 329 participants 163 participants 492 participants
No 175 87 262
Yes 154 76 230
Disease duration  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 329 participants 163 participants 492 participants
1.13  (1.39) 0.91  (1.19) 1.06  (1.33)
Forced vital capacity (FVC) percent predicted  
Least Squares Mean (Standard Deviation)
Unit of measure:  Percentage of FVC % predicted
Number Analyzed 329 participants 163 participants 492 participants
68.74  (13.12) 69.86  (13.75) 69.11  (13.33)
Six mile walk test (6MWT)  
Mean (Standard Deviation)
Unit of measure:  Meters
Number Analyzed 329 participants 163 participants 492 participants
410.4  (118.7) 420.5  (121.4) 413.7  (119.6)
Hemoglobin Adjusted Diffusing lung capacity for carbon monoxide (DLCO) percent predicted  
Least Squares Mean (Standard Deviation)
Unit of measure:  Percentage of DLCO % predicted
Number Analyzed 329 participants 163 participants 492 participants
42.04  (13.77) 45.57  (13.25) 43.20  (13.69)
Prior IPF Medications   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 329 participants 163 participants 492 participants
No 205 97 302
Yes 124 65 189
[1]
Measure Description: Prior IPF Medications data is missing for one participant randomized to placebo.
N-acetylcysteine (NAC) Use   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 329 participants 163 participants 492 participants
No 310 153 463
Yes 19 8 27
[1]
Measure Description: NAC is a therapy commonly used in the treatment of IPF. NAC use data is missing for two participants randomized to placebo.
1.Primary Outcome
Title Time to Death or Disease (IPF) Progression.
Hide Description

The median time to death or disease progression was based on Kaplan-Meier (KM) estimates of pooling over strata, and was defined as the first occurrence of any of the following:

  • Either 1) a decrease of ≥ 10% in FVC (L) and a decrease of ≥ 5% in diffuse lung capacity for carbon monoxide (DLCO) (ml/min/mmHg), or 2) a decrease of ≥ 5% in FVC (L) and a decrease of ≥ 15% in DLCO (ml/min/mmHg); deterioration in FVC and DLCO must be confirmed at the subsequent visit within 28 (± 14) days
  • Respiratory hospitalization (hospitalization involving worsening of, or deterioration in respiratory symptoms, gas exchange/hypoxemia, or radiographic findings on chest x-ray or high-resolution computerised tomography (HRCT) scan
  • All-cause mortality
Time Frame Up to 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: participants who were randomized and treated
Arm/Group Title Ambrisentan Placebo
Hide Arm/Group Description:
Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
Placebo to match ambrisentan administered orally once daily
Overall Number of Participants Analyzed 329 163
Median (Inter-Quartile Range)
Unit of Measure: weeks
84.14 [1] 
(36.00 to NA)
NA [1] 
(60.00 to NA)
[1]
Insufficient data for estimation due to study termination
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ambrisentan, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments P-value was based on a stratified log-rank test with strata of baseline presence of pulmonary hypertension and whether a surgical lung biopsy was performed with definite or probable usual interstitial pneumonia (UIP) based on core pathology review.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.74
Confidence Interval (2-Sided) 95%
1.14 to 2.66
Estimation Comments The hazard ratio was based on a stratified Cox proportional hazards model with strata of baseline presence of pulmonary hypertension and whether a surgical lung biopsy was performed with definite or probable UIP based on core pathology review.
2.Secondary Outcome
Title Proportion of Participants With No Disease Progression or Death at 48 Weeks
Hide Description The proportion of participants with no disease progression or death is presented as a percentage using a Kaplan-Meier (KM) estimate of survival or not experiencing disease progression.
Time Frame Baseline and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Ambrisentan Placebo
Hide Arm/Group Description:
Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
Placebo to match ambrisentan administered orally once daily
Overall Number of Participants Analyzed 329 163
Measure Type: Number
Unit of Measure: percentage of participants
65 80
3.Secondary Outcome
Title Change in FVC % Predicted at Week 48
Hide Description FVC is defined as the volume of air (liters) that can forcibly be blown out after taking a full breath. FVC % predicted is defined as FVC % of the participant divided by the average FVC % in the population for any person of similar age, sex, and body composition.
Time Frame Baseline and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with evaluable change data were analyzed.
Arm/Group Title Ambrisentan Placebo
Hide Arm/Group Description:
Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
Placebo to match ambrisentan administered orally once daily
Overall Number of Participants Analyzed 163 80
Mean (Standard Deviation)
Unit of Measure: percent change in FVC % predicted
-10.24  (25.95) -5.28  (15.68)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ambrisentan, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.086
Comments P-value was calculated using the Van Elteren test with strata of baseline presence of PH and whether a SLB was performed with definite or probable UIP based on core pathology review.
Method Van Elteren test
Comments [Not Specified]
Method of Estimation Estimation Parameter Point estimate
Estimated Value 4.29
Confidence Interval (2-Sided) 95%
-0.805 to 9.376
Estimation Comments The point estimate and 95% confidence interval (CI) were based on the Hodges-Lehmann Estimate of treatment effect for percent change from baseline.
4.Secondary Outcome
Title Change in DLCO % Predicted at Week 48
Hide Description DLCO is the extent to which oxygen passes from the air sacs of the lungs into the blood. DLCO % predicted is defined as DLCO % of the participant divided by the average DLCO % in the population for any person of similar age, sex and body composition.
Time Frame Baseline and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with evaluable change data were analyzed.
Arm/Group Title Ambrisentan Placebo
Hide Arm/Group Description:
Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
Placebo to match ambrisentan administered orally once daily
Overall Number of Participants Analyzed 163 80
Mean (Standard Deviation)
Unit of Measure: percent change in DLCO % predicted
-2.68  (27.60) -11.28  (32.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ambrisentan, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.250
Comments P-value was calculated using the Van Elteren test with strata of baseline presence of PH and whether a SLB was performed with definite or probable UIP based on core pathology review.
Method Van Elteren test
Comments [Not Specified]
Method of Estimation Estimation Parameter Point estimate
Estimated Value 2.85
Confidence Interval (2-Sided) 95%
-2.20 to 7.90
Estimation Comments The point estimate and its 95% CI were based on the Hodges-Lehmann Estimate of treatment effect for percent change from baseline.
5.Secondary Outcome
Title Change in 6MWT at Week 48
Hide Description The 6MWT is a measure of exercise tolerance, and measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface.
Time Frame Baseline and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with evaluable change data were analyzed.
Arm/Group Title Ambrisentan Placebo
Hide Arm/Group Description:
Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
Placebo to match ambrisentan administered orally once daily
Overall Number of Participants Analyzed 162 80
Mean (Standard Deviation)
Unit of Measure: meters
-52.5  (148.7) -10.6  (89.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ambrisentan, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.150
Comments P-value was calculated using the Van Elteren test with strata of baseline presence of PH and whether a SLB was performed with definite or probable UIP based on core pathology review.
Method Van Elteren test
Comments [Not Specified]
Method of Estimation Estimation Parameter Point estimate
Estimated Value 16.00
Confidence Interval (2-Sided) 95%
-5.00 to 37.00
Estimation Comments The point estimate and 95% CI were based on the Hodges-Lehmann Estimate of treatment effect for percent change from baseline.
6.Secondary Outcome
Title Change in Quality of Life (QOL) Score at Week 48 as Assessed by the Short-Form 36® (SF-36)
Hide Description The range of each health domain score is 0-100, with 0 indicating a poorer health state and 100 indicating a better health state. An increase in score indicates an improvement in health state.
Time Frame Baseline and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with evaluable change data were analyzed.
Arm/Group Title Ambrisentan Placebo
Hide Arm/Group Description:
Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
Placebo to match ambrisentan administered orally once daily
Overall Number of Participants Analyzed 158 78
Mean (Standard Deviation)
Unit of Measure: units on a scale
Physical function -1.65  (10.86) -2.60  (7.25)
General Health -2.81  (9.77) -1.95  (8.63)
Vitality -1.67  (12.67) -0.12  (7.69)
7.Secondary Outcome
Title Change in Quality of Life (QOL) Score at Week 48 as Assessed by the St. George’s Respiratory Questionnaire (SGRQ)
Hide Description The SGRQ is designed to measure impact on overall health, daily life, and perceived well-being in participants with obstructive airways disease. The range of each score is 0-100, with 0 indicating fewer limitations and 100 indicating more limitations; an increase in score indicates an increase in limitations.
Time Frame Baseline and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with evaluable change data were analyzed.
Arm/Group Title Ambrisentan Placebo
Hide Arm/Group Description:
Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
Placebo to match ambrisentan administered orally once daily
Overall Number of Participants Analyzed 159 78
Mean (Standard Deviation)
Unit of Measure: units on a scale
Symptoms Score 3.30  (22.11) 2.84  (20.43)
Activity Score 5.54  (19.38) 2.05  (16.47)
Impacts Score 4.68  (24.07) 3.09  (15.80)
Total Score 4.70  (19.92) 3.04  (13.80)
8.Secondary Outcome
Title Change in Dyspnea Score at Week 48 as Assessed by the Transitional Dyspnea Index (TDI)
Hide Description The transitional focal score (-9 to 9) is the sum of relative change from baseline for the Functional Impairment, Magnitude of Task, and Magnitude of Effort scores (each -3 to 3 scale). A TDI score of -9 represents a maximum degradation of all three tests; a score of 9 represents a maximum improvement of all three tests.
Time Frame Baseline and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with evaluable change data were analyzed.
Arm/Group Title Ambrisentan Placebo
Hide Arm/Group Description:
Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
Placebo to match ambrisentan administered orally once daily
Overall Number of Participants Analyzed 163 80
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.23  (3.74) -0.84  (2.99)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ambrisentan, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.793
Comments The p-value was based on a Wilcoxon rank sum test stratified by baseline pulmonary hypertension (Yes/No) and surgical lung biopsy was performed with definite or probable UIP based on core pathology review (Yes/No).
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Point estimate
Estimated Value 0.50
Confidence Interval (2-Sided) 95%
0.00 to 1.00
Estimation Comments The point estimate and 95% confidence interval were based on the Hodges-Lehmann Estimate of treatment effect
9.Secondary Outcome
Title Percentage of Participants Who Developed PH on Study
Hide Description The percentage of participants known to have developed pulmonary hypertension on study documented by right heart catheterization (RHC) was analyzed. RHC was done at baseline and 48 weeks, or at the early termination visit.
Time Frame Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set without PH at baseline were analyzed.
Arm/Group Title Ambrisentan Placebo
Hide Arm/Group Description:
Ambrisentan (5 mg or 10 mg tablet) administered orally once daily
Placebo to match ambrisentan administered orally once daily
Overall Number of Participants Analyzed 293 145
Measure Type: Number
Unit of Measure: percentage of participants
0.7 2.1
Time Frame Up to 48 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ambrisentan Placebo
Hide Arm/Group Description Ambrisentan (5 mg or 10 mg tablet) administered orally once daily Placebo to match ambrisentan administered orally once daily
All-Cause Mortality
Ambrisentan Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ambrisentan Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   73/329 (22.19%)   25/163 (15.34%) 
Blood and lymphatic system disorders     
Anaemia  1  1/329 (0.30%)  0/163 (0.00%) 
Cardiac disorders     
Acute myocardial infarction  1  3/329 (0.91%)  0/163 (0.00%) 
Angina pectoris  1  1/329 (0.30%)  0/163 (0.00%) 
Angina unstable  1  1/329 (0.30%)  0/163 (0.00%) 
Atrial fibrillation  1  2/329 (0.61%)  0/163 (0.00%) 
Sinus tachycardia  1  1/329 (0.30%)  0/163 (0.00%) 
Cardiac failure congestive  1  4/329 (1.22%)  0/163 (0.00%) 
Cardiomegaly  1  1/329 (0.30%)  0/163 (0.00%) 
Dilatation atrial  1  1/329 (0.30%)  0/163 (0.00%) 
Tricuspid valve incompetence  1  1/329 (0.30%)  0/163 (0.00%) 
Palpitations  1  1/329 (0.30%)  0/163 (0.00%) 
Extrasystoles  1  1/329 (0.30%)  0/163 (0.00%) 
Electromechanical dissociation  1  1/329 (0.30%)  0/163 (0.00%) 
Cardiac ventricular disorder  1  1/329 (0.30%)  0/163 (0.00%) 
Ear and labyrinth disorders     
Acute vestibular syndrome  1  1/329 (0.30%)  0/163 (0.00%) 
Eye disorders     
Cataract  1  0/329 (0.00%)  1/163 (0.61%) 
Choroidal haemorrage  1  0/329 (0.00%)  1/163 (0.61%) 
Visual impairment  1  1/329 (0.30%)  0/163 (0.00%) 
Gastrointestinal disorders     
Constipation  1  4/329 (1.22%)  0/163 (0.00%) 
Gastrooesophageal reflux disease  1  2/329 (0.61%)  2/163 (1.23%) 
Diarrhoea  1  1/329 (0.30%)  1/163 (0.61%) 
Colitis  1  1/329 (0.30%)  1/163 (0.61%) 
Nausea  1  2/329 (0.61%)  0/163 (0.00%) 
Colonic polyp  1  1/329 (0.30%)  0/163 (0.00%) 
Small intestinal obstruction  1  1/329 (0.30%)  0/163 (0.00%) 
Abdominal pain upper  1  0/329 (0.00%)  1/163 (0.61%) 
Upper gastrointestinal haemorrhage  1  1/329 (0.30%)  0/163 (0.00%) 
Aptyalism  1  0/329 (0.00%)  1/163 (0.61%) 
General disorders     
Oedema peripheral  1  4/329 (1.22%)  1/163 (0.61%) 
Oedema  1  1/329 (0.30%)  0/163 (0.00%) 
Chest pain  1  2/329 (0.61%)  1/163 (0.61%) 
Pain  1  2/329 (0.61%)  0/163 (0.00%) 
Pyrexia  1  2/329 (0.61%)  0/163 (0.00%) 
Fatigue  1  2/329 (0.61%)  0/163 (0.00%) 
Catheter site haemorrhage  1  1/329 (0.30%)  0/163 (0.00%) 
Influenza like illness  1  1/329 (0.30%)  0/163 (0.00%) 
Hyperthermia  1  1/329 (0.30%)  0/163 (0.00%) 
Infections and infestations     
Nasopharyngitis  1  2/329 (0.61%)  2/163 (1.23%) 
Upper respiratory tract infection  1  1/329 (0.30%)  1/163 (0.61%) 
Pharyngitis  1  1/329 (0.30%)  0/163 (0.00%) 
Sinusitis  1  1/329 (0.30%)  0/163 (0.00%) 
Pneumonia  1  9/329 (2.74%)  2/163 (1.23%) 
Bronchitis  1  3/329 (0.91%)  0/163 (0.00%) 
Lobar pneumonia  1  1/329 (0.30%)  1/163 (0.61%) 
Bronchopneumonia  1  1/329 (0.30%)  0/163 (0.00%) 
Lower respiratory tract infection  1  0/329 (0.00%)  1/163 (0.61%) 
Respiratory tract infection  1  2/329 (0.61%)  1/163 (0.61%) 
Infection  1  1/329 (0.30%)  0/163 (0.00%) 
Cellulitis  1  2/329 (0.61%)  0/163 (0.00%) 
Endocarditis bacterial  1  1/329 (0.30%)  1/163 (0.61%) 
Sepsis  1  2/329 (0.61%)  0/163 (0.00%) 
Bacteraemia  1  0/329 (0.00%)  1/163 (0.61%) 
Appendicitis  1  0/329 (0.00%)  1/163 (0.61%) 
Influenza  1  2/329 (0.61%)  0/163 (0.00%) 
Urinary tract infection  1  1/329 (0.30%)  0/163 (0.00%) 
Oral candidiasis  1  1/329 (0.30%)  0/163 (0.00%) 
Conjunctivitis viral  1  1/329 (0.30%)  0/163 (0.00%) 
Injury, poisoning and procedural complications     
Road traffic accident  1  1/329 (0.30%)  0/163 (0.00%) 
Rib fracture  1  1/329 (0.30%)  0/163 (0.00%) 
Investigations     
Alanine aminotransferase increased  1  0/329 (0.00%)  2/163 (1.23%) 
Aspartate aminotransferase increased  1  0/329 (0.00%)  1/163 (0.61%) 
Hepatic enzyme increased  1  0/329 (0.00%)  1/163 (0.61%) 
Electrocardiogram ST-T segment abnormal  1  1/329 (0.30%)  0/163 (0.00%) 
Electrocardiogram T wave inversion  1  1/329 (0.30%)  0/163 (0.00%) 
Computerised tomogram thorax abnormal  1  1/329 (0.30%)  0/163 (0.00%) 
Metabolism and nutrition disorders     
Hyperkalaemia  1  4/329 (1.22%)  0/163 (0.00%) 
Hypokalaemia  1  2/329 (0.61%)  0/163 (0.00%) 
Hyperglycaemia  1  2/329 (0.61%)  0/163 (0.00%) 
Anorexia  1  1/329 (0.30%)  0/163 (0.00%) 
Diabetic ketoacidosis  1  1/329 (0.30%)  0/163 (0.00%) 
Hypophosphataemia  1  1/329 (0.30%)  0/163 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/329 (0.30%)  0/163 (0.00%) 
Musculoskeletal pain  1  1/329 (0.30%)  0/163 (0.00%) 
Osteoarthritis  1  2/329 (0.61%)  1/163 (0.61%) 
Clubbing  1  1/329 (0.30%)  0/163 (0.00%) 
Joint swelling  1  0/329 (0.00%)  1/163 (0.61%) 
Pain in jaw  1  1/329 (0.30%)  0/163 (0.00%) 
Myalgia  1  1/329 (0.30%)  0/163 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1  0/329 (0.00%)  1/163 (0.61%) 
Squamous cell carcinoma  1  1/329 (0.30%)  0/163 (0.00%) 
Prostate cancer  1  1/329 (0.30%)  0/163 (0.00%) 
Prostate cancer metastatic  1  1/329 (0.30%)  0/163 (0.00%) 
Lung neoplasm malignant  1  1/329 (0.30%)  0/163 (0.00%) 
Malignant melanoma  1  0/329 (0.00%)  1/163 (0.61%) 
Nervous system disorders     
Headache  1  5/329 (1.52%)  1/163 (0.61%) 
Cerebrovascular accident  1  1/329 (0.30%)  0/163 (0.00%) 
Ischaemic stroke  1  1/329 (0.30%)  0/163 (0.00%) 
Syncope  1  1/329 (0.30%)  1/163 (0.61%) 
Somnolence  1  1/329 (0.30%)  0/163 (0.00%) 
Carotid artery stenosis  1  1/329 (0.30%)  0/163 (0.00%) 
Coma  1  1/329 (0.30%)  0/163 (0.00%) 
Grand mal convulsion  1  1/329 (0.30%)  0/163 (0.00%) 
Nerve compression  1  1/329 (0.30%)  0/163 (0.00%) 
Hypoaesthesia  1  1/329 (0.30%)  0/163 (0.00%) 
Psychiatric disorders     
Anxiety  1  3/329 (0.91%)  0/163 (0.00%) 
Delirium  1  1/329 (0.30%)  0/163 (0.00%) 
Insomnia  1  1/329 (0.30%)  0/163 (0.00%) 
Renal and urinary disorders     
Renal failure acute  1  2/329 (0.61%)  0/163 (0.00%) 
Renal failure  1  1/329 (0.30%)  0/163 (0.00%) 
Reproductive system and breast disorders     
Prostatomegaly  1  0/329 (0.00%)  1/163 (0.61%) 
Benign prostatic hyperplasia  1  1/329 (0.30%)  0/163 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Idiopathic pulmonary fibrosis  1  20/329 (6.08%)  4/163 (2.45%) 
Emphysema  1  2/329 (0.61%)  0/163 (0.00%) 
Pulmonary fibrosis  1  2/329 (0.61%)  0/163 (0.00%) 
Pulmonary alveolar haemorrhage  1  1/329 (0.30%)  0/163 (0.00%) 
Dyspnoea  1  17/329 (5.17%)  2/163 (1.23%) 
Respiratory arrest  1  1/329 (0.30%)  0/163 (0.00%) 
Cough  1  4/329 (1.22%)  1/163 (0.61%) 
Haemoptysis  1  4/329 (1.22%)  0/163 (0.00%) 
Productive cough  1  1/329 (0.30%)  0/163 (0.00%) 
Acute respiratory failure  1  5/329 (1.52%)  1/163 (0.61%) 
Respiratory failure  1  4/329 (1.22%)  0/163 (0.00%) 
Nasal congestion  1  4/329 (1.22%)  0/163 (0.00%) 
Rhinitis allergic  1  1/329 (0.30%)  0/163 (0.00%) 
Choking  1  1/329 (0.30%)  0/163 (0.00%) 
Rhinorrhoea  1  1/329 (0.30%)  0/163 (0.00%) 
Hypoxia  1  1/329 (0.30%)  0/163 (0.00%) 
Pneumothorax  1  1/329 (0.30%)  0/163 (0.00%) 
Pneumonitis  1  1/329 (0.30%)  0/163 (0.00%) 
Hiccups  1  1/329 (0.30%)  0/163 (0.00%) 
Epistaxis  1  0/329 (0.00%)  1/163 (0.61%) 
Pleurisy  1  1/329 (0.30%)  0/163 (0.00%) 
Pulmonary embolism  1  0/329 (0.00%)  1/163 (0.61%) 
Skin and subcutaneous tissue disorders     
Rash  1  0/329 (0.00%)  1/163 (0.61%) 
Vascular disorders     
Hypotension  1  4/329 (1.22%)  1/163 (0.61%) 
Hypertension  1  3/329 (0.91%)  0/163 (0.00%) 
Subclavian vein thrombosis  1  1/329 (0.30%)  0/163 (0.00%) 
Flushing  1  1/329 (0.30%)  0/163 (0.00%) 
Hot flush  1  1/329 (0.30%)  0/163 (0.00%) 
Peripheral ischaemia  1  1/329 (0.30%)  0/163 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ambrisentan Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   227/329 (69.00%)   104/163 (63.80%) 
Gastrointestinal disorders     
Constipation  1  19/329 (5.78%)  10/163 (6.13%) 
Diarrhoea  1  20/329 (6.08%)  8/163 (4.91%) 
Nausea  1  15/329 (4.56%)  9/163 (5.52%) 
General disorders     
Oedema peripheral  1  73/329 (22.19%)  14/163 (8.59%) 
Fatigue  1  22/329 (6.69%)  14/163 (8.59%) 
Infections and infestations     
Nasopharyngitis  1  37/329 (11.25%)  18/163 (11.04%) 
Bronchitis  1  23/329 (6.99%)  15/163 (9.20%) 
Sinusitis  1  20/329 (6.08%)  6/163 (3.68%) 
Respiratory tract infection  1  9/329 (2.74%)  12/163 (7.36%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  18/329 (5.47%)  5/163 (3.07%) 
Nervous system disorders     
Headache  1  47/329 (14.29%)  17/163 (10.43%) 
Dizziness  1  20/329 (6.08%)  2/163 (1.23%) 
Respiratory, thoracic and mediastinal disorders     
Upper respiratory tract infection  1  47/329 (14.29%)  18/163 (11.04%) 
Dyspnoea  1  40/329 (12.16%)  11/163 (6.75%) 
Cough  1  34/329 (10.33%)  20/163 (12.27%) 
Idiopathic pulmonary fibrosis  1  19/329 (5.78%)  2/163 (1.23%) 
Nasal congestion  1  27/329 (8.21%)  6/163 (3.68%) 
Productive cough  1  8/329 (2.43%)  9/163 (5.52%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.1)
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
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences, Inc.
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00768300     History of Changes
Other Study ID Numbers: GS-US-231-0101
First Submitted: October 7, 2008
First Posted: October 8, 2008
Results First Submitted: July 15, 2013
Results First Posted: April 8, 2014
Last Update Posted: April 8, 2014