Pulmonary Arterial Hypertension MedDRA version: 7.0 Level: low Classification code 10037400
Conditions
Interventions
Product Name: Ambrisentan
Product Code: BSF 208075
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Ambrisentan
Current Sponsor code: BSF 208075
Concentration unit: mg milligram(s)
Concen
Sponsors
Myogen Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject must be between 12 and 75 years of age 2. Subject must have a current diagnosis of IPAH, FPAH or PAH associated with: a. Collagen vascular disease(e.g., mixed connective tissue disease, CREST syndrome, systemic sclerosis, overlap syndrome, or systemic lupus erythematosus) b. Congenital systemic-to pulmonary shunts(repaired atrial septal defects, repaired ventricular septal defects, repaired patent ductus arteriosus greater than one year post-operative, or unrepaired secundum atrial septal defect with resting arterial oxygen saturation greater than 88%)c. Anorexigen used. HIV infection 3. Subject must have previously discontinued bosentan or sitaxsentan therapy due to serumaminotransferase (ALT and/or AST) concentrations >3xULN 4. Subject must have normal (=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subject with PAH due to or associated with coronary artery disease, left heart disease, interstitial lung disease, chronic obstructive pulmonary disease, veno-occlusive disease, chronic thromboticand/or embolic disease, or sleep apnea 2. Subject with portopulmonary hypertension 3. Subject who has, as measured by historical pulmonary function tests: a. Total lung capacity (TLC) <70% of predicted normal or b. Forced expiratory volume in one second (FEV1) <65% of predicted normal 4. Subject who has : a. A hemoglobin concentration <10 g/dl at the Screening Visit or b. A hematocrit <30% at the Screening Visit 5. Subject with or without supplemental oxygen, who has a resting arterial oxygen saturation (SaO2) <90 % as measured by pulse oximetry at the Screening Visit 6. Subject who has a history of malignancies within the past 5 years, with the exception of basal cell carcinoma of the skin or in situ carcinoma of the cervix 7. Subject with cardiovascular, liver, renal, hematologic, gastrointestinal, immunologic, endocrine, metabolic, or central nervous system disease that, in the opinion of the investigator, may adversely affect the safety of the subject and / or efficacy of ambrisentan or severely limit the lifespan of the subject 8. Female subject who is pregnant or breastfeeding 9. Subject who has demonstrated non-compliance with previous medical regimens 10. Subject who has a recent history of abusing alcohol or illicit drugs 11. Subject who has participated in a clinical study involving another investigational drug or device within 4 weeks before the Screening Visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the incidence of increased serum aminotransferase concentrations in subjects who have previously discontinued ERA therapy (bosentan or sitaxsentan) due to serum aminotransferase abnormalities. ;Secondary Objective: The secondary objectives of this study are to evaluate the safety, tolerability, and efficacy of ambrisentan in this patient population.;Primary end point(s): The primary endpoint of this study is the incidence of confirmed serum aminotransferase concentrations >3xULN during 12 weeks of ambrisentan therapy that are related to ambrisentan and resulted in discontinuation of drug | — |
Countries
Belgium, Germany
Outcome results
None listed