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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 January 2021 |
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Main ID: |
NCT02169752 |
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Date of registration:
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06/05/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Ambrisentan for the Improvement in Right Ventricular Strain in Scleroderma Associated Pulmonary Arterial Hypertension
AMERICA-PAH |
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Scientific title:
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Ambrisentan for the Improvement in Right Ventricular Strain in Scleroderma Associated Pulmonary Arterial Hypertension |
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Date of first enrolment:
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September 2012 |
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Target sample size:
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7 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02169752 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Brett Fenster, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Jewish Health |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age >18 years, < 80 years
- Systemic sclerosis with any of the following features:
1. Duration of Raynaud's phenomena >8 years
2. Anticentromere antibody positivity
3. isolated nucleolar-pattern ANA positivity
4. Extensive telangiectasias
5. DLCO < 60% in the absence of extensive ILD
6. FVC%/DLCO% >1.6
7. Unexplained dyspnea
- Right heart catheterization-proven pre PAH (mean PAP 20-25 mmHg and pulmonary
capillary wedge pressure <15 mmHg)
- Systolic blood pressure >100 mmHg
- Reliable contraception for women of childbearing age
- Informed consent
Exclusion Criteria:
- < 18 years or > 80 years
- Left ventricular ejection fraction < 55%
- Systolic or diastolic left ventricular congestive heart failure
- Liver disease (abnormal AST/ALT, chronic hepatitis, or cirrhosis)
- Extensive ILD or FVC< 60%
- Pregnant
- Breast-feeding women
- Cyclosporine use
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pre-Pulmonary Atrial Hypertension
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Intervention(s)
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Drug: Ambrisentan
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Primary Outcome(s)
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Improvement in right ventricular (RV) myocardio strain > 2%
[Time Frame: 1, 3 and 6 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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