Last updated: 11/03/2018 13:03:55
A Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension (PAH)AMBITION
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension (PAH)
Trial description: The purpose of this study is to compare the two treatment strategies; first-line combination therapy (ambrisentan and tadalafil) versus first-line monotherapy (ambrisentan or tadalafil) in subjects with Pulmonary Arterial Hypertension. This will be assessed by time to the first clinical failure event.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Number of participants with first adjudicated clinical failure (CF) event, death, hospitalisation for worsening PAH, disease progression, unsatisfactory long-term clinical response, all through FAV
Timeframe: From Baseline up to the Final Assessment Visit (FAV) (average of 609 days)
Secondary outcomes:
Percent change from Baseline in the N-Terminal Pro-B-Type Natriuretic Peptide at Week 24
Timeframe: Baseline and Week 24
Percentage of participants with a satisfactory clinical response at Week 24
Timeframe: Baseline and Week 24
Change from Baseline in the 6 minute walk distance test at Week 24
Timeframe: Baseline and Week 24
Change from Baseline in the World Health Organization Functional Class at Week 24
Timeframe: Baseline and Week 24
Change from Baseline in Borg Dyspnea Index at Week 24
Timeframe: Baseline (BL) and Week 24
Interventions:
Enrollment:
610
Primary completion date:
2014-31-07
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Hypertension, Pulmonary
Product
ambrisentan
Collaborators
Gilead Sciences
Study date(s)
October 2010 to July 2014
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 75 years
Accepts healthy volunteers
No
- Subjects must have a diagnosis of Pulmonary Arterial Hypertension (PAH) due to the following:
- a. idiopathic or heritable PAH
- Subject received previous PAH therapy (phosphodiesterase type 5 inhibitor (PDE5i), endothelin receptor antagonist (ERA), chronic prostanoid*) within 4 weeks prior to the screening visit (*Chronic prostanoid use is considered >7 days of treatment)
- Subject received ERA treatment (e.g., bosentan or sitaxentan) or PDE5i treatment (e.g. Sildenafil) at any time AND discontinued due to tolerance issues other than those associated with liver function abnormalities
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects must have a diagnosis of Pulmonary Arterial Hypertension (PAH) due to the following: a. idiopathic or heritable PAH b. PAH associated with: i. connective tissue disease (e.g., limited scleroderma, diffuse scleroderma, mixed connective tissue disease, systemic lupus erythematosus, or overlap syndrome) ii. drugs or toxins iii. Human Immunodeficiency Virus (HIV) infection iv. congenital heart defects repaired greater than 1 year prior to screening (i.e., atrial septal defects, ventricular septal defects, and patent ductus arteriosus) NB: subjects with portopulmonary hypertension and pulmonary veno-occlusive disease are NOT eligible for the study
- Subject must have a current diagnosis of being in World Health Organisation (WHO) Functional Class II or III.
- Subject must meet all of the following haemodynamic criteria by means of a right heart catheterization prior to screening: i. mPAP of ≥25 mmHg ii. PVR ≥ 300 dynes/sec/cm5 iii. PCWP or LVEDP of ≤12 mmHg if PVR ≥300 to <500 dyne/sec/cm5 , or PCWP/LVEDP ≤ 15 mmHg if PVR ≥500 dynes/sec/cm5
- Subject must walk a distance of ≥125m and ≤500m at the screening visit
Exclusion criteria:
- Subject received previous PAH therapy (phosphodiesterase type 5 inhibitor (PDE5i), endothelin receptor antagonist (ERA), chronic prostanoid*) within 4 weeks prior to the screening visit (*Chronic prostanoid use is considered >7 days of treatment)
- Subject received ERA treatment (e.g., bosentan or sitaxentan) or PDE5i treatment (e.g. Sildenafil) at any time AND discontinued due to tolerance issues other than those associated with liver function abnormalities
- Subjects who have previously discontinued ambrisentan or tadalafil in either another clinical study or commercial product (Volibris/Letairis or Adcirca) for safety or tolerability reasons.
Trial location(s)
Location
GSK Investigational Site
New Orleans, Louisiana, United States, 70112
Status
Study Complete
Location
GSK Investigational Site
Gainesville, Florida, United States, 32610
Status
Study Complete
Location
GSK Investigational Site
Decatur, Georgia, United States, 30030
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Ann Arbor, Michigan, United States, 48109
Status
Study Complete
Showing 1 - 6 of 143 Results
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2014-31-07
Actual study completion date
2014-31-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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