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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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4 January 2022 |
Main ID: |
EUCTR2005-001564-31-DE |
Date of registration:
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08/07/2005 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A phase 2, Open-label, Multicenter Study Evaluating Ambrisentan in Subjects with Pulmonary Arterial Hypertension Who Have Previously Discontinued Endothelin Receptor Antagonist Therapy Due to Serum Aminotransferase Abnormalities - NA
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Scientific title:
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A phase 2, Open-label, Multicenter Study Evaluating Ambrisentan in Subjects with Pulmonary Arterial Hypertension Who Have Previously Discontinued Endothelin Receptor Antagonist Therapy Due to Serum Aminotransferase Abnormalities - NA |
Date of first enrolment:
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07/10/2005 |
Target sample size:
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30 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-001564-31 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no Randomised: no Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Belgium
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Germany
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Key inclusion & exclusion criteria
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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 (<1xULN) serum aminotransferase concentrations at the Screening Visit 5. Subject must walk a distance of at least 150 meters during the 6MWT at the Screening Visit 6. Subject receiving sildenafil for PAH must be on stable therapy for at least 4 weeks prior to screening 7. Subject receiving a clinically approved prostanoid (epoprostenol, treprostinil, iloprost) must be on stable therapy for at least 4 weeks prior to screening 8. Subject with a diagnosis of HIV must have stable disease status during the Screening Period.Stable HIV status is defined as: a. No addition of medications for treatment of HIV in the last 2 months b. No active opportunistic infection during the Screening Period c. No hospitalizations due to HIV within the past 4 weeks 9. Female subject of childbearing potential must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at the Randomization Visit. Female subject who is surgically sterile or post-menopausal for at least 2 years is not considered to be of childbearing potential 10. Female subject of childbearing potential must agree to use a reliable double barrier method ofcontraception until study completion and for at least 4 weeks following their final study visit. A reliable double barrier method of contraception is considered to be a combination of TWO of the following: birth control pills/ implants/ injections, intrauterine devices, spermicide, diaphragms, or condoms 11. Male subject must be informed of the potential risks of testicular tubular atrophy and infertilityassociated with taking ambrisentan and queried regarding his understanding of the potential risks as described in the Informed Consent Form (ICF)12. Subject must be competent to understand the information given in the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approved ICF and must sign the form prior to the initiation of any study procedures Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
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
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Pulmonary Arterial Hypertension MedDRA version: 7.0
Level: low
Classification code 10037400
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Intervention(s)
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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) Concentration type: equal Concentration number: 2.5-
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) Concentration type: equal Concentration number: 5.0-
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) Concentration type: equal Concentration number: 10.0-
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Primary Outcome(s)
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Secondary Objective: The secondary objectives of this study are to evaluate the safety, tolerability, and efficacy of ambrisentan in this patient population.
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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.
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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
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 08/08/2005
Contact:
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