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
CAS Number: 177036-94-1
Current Sponsor code: BSF 208075
Concentration unit:
Sponsors
Myogen, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to be considered eligible, a subject must meet all of the following criteria: 1. Subject must be at least 18 years of age; 2. Subject must have a current diagnosis of either PPH or PAH secondary to the scleroderma spectrum of disease (e.g., mixed connective tissue disease, CREST syndrome, systemic sclerosis, or overlap syndrome), systemic lupus erythematosus, anorexigen use, or HIV infection at the Screening Visit; 3. By means of a right heart catheterization, completed prior to Screening Visit, the subject must meet all of the following hemodynamic criteria:· Mean PAP of = 25 mmHg;· PVR >3 mmHg/L/min;· PCWP or LVEDP of =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A subject who meets any one of the following criteria is ineligible for participation in the study: 1. Subject with PAH due to or associated with congenital heart disease, coronary artery disease, left heart disease, interstitial lung disease, chronic obstructive pulmonary disease, veno-occlusive disease, chronic thrombotic and/or embolic disease, or sleep apnea; 2. Subject with portopulmonary hypertension; 3. Subject receiving bosentan within four weeks prior to the Screening Visit; 4. Subject receiving a phosphodiesterase type V inhibitor (sildenafil, vardenafil, tadalafil, etc.) within four weeks prior to the Screening Visit; 5. Subject receiving chronic prostanoid therapy (epoprostenol, treprostinil, iloprost, beraprost, or any other investigational prostacyclin derivative) within four weeks prior to the Screening Visit; 6. Subject receiving iv inotropes within two weeks prior to the Screening Visit; 7. Subject who has a serum ALT or AST lab value that is greater than 1.5 times the upper limit of normal at the Screening Visit; 8. Subject who has, as measured by a historical pulmonary function test: · Total lung capacity (TLC) <70% of predicted normal or; · Forced expiratory volume in one second (FEV1) <65% of predicted normal; 9. Subject who has: · A hemoglobin concentration <10 g/dL at the Screening Visit or; · A hematocrit <30% at the Screening Visit; 10. Subject, with or without supplemental oxygen, who has a resting arterial oxygen saturation (SaO2) <90% as measured by pulse oximetry at the Screening Visit; 11. Subject who has a contraindication to treatment with an ETRA. The contraindications include, but are not limited to, evidence of elevated LFTs or an event defined as a SAE attributed to previous treatment with an ETRA; 12. Subject who has a history of malignancies within the past five years, with the exception of basal cell carcinoma of the skin or in situ carcinoma of the cervix; 13. 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 the study drug or severely limit the lifespan of the subject; 14. Female subject who is pregnant or breastfeeding; 15. Subject who has demonstrated noncompliance with previous medical regimens; 16. Subject who has a recent history of abusing alcohol or illicit drugs; 17. Subject who has participated in a clinical study involving another investigational drug or device within four weeks before the Screening Visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effect of ambrisentan on excercise capacity in subjects with PAH;Secondary Objective: To evaluate the effects of ambrisentan on other clinical measures of PAH, as well as the safety and tolerability of the study drug;Primary end point(s): The primary efficacy endpoint is the change from baseline in the six-minute walk distance evaluated after 12 weeks of therapy compared to placebo. This study will have approximately 90% power to detect a placebo-corrected treatment effect of 35 meters. | — |
Countries
Austria, Belgium, Germany, Hungary, Italy, Spain
Outcome results
None listed