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Sponsored by: |
Gilead Sciences |
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Information provided by: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT00380068 |
The primary objective of this study is to evaluate the safety and efficacy of ambrisentan in a broad population of subjects with pulmonary hypertension. Secondary objectives of this study are to evaluate the effects of ambrisentan on other clinical measures of PAH, long-term treatment success, and survival.
Condition | Intervention | Phase |
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Pulmonary Hypertension |
Drug: Ambrisentan |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | ARIES-3: A Phase 3, Long-Term, Open-Label, Multicenter Safety and Efficacy Study of Ambrisentan in Subjects With Pulmonary Hypertension |
Estimated Enrollment: | 200 |
Study Start Date: | August 2006 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
This study will enroll up to 200 subjects with PAH and in PH subgroups including PH associated with interstitial lung disease (ILD); PH due to chronic thromboembolic disease or sickle cell disease; PH associated with chronic obstructive pulmonary disease (COPD); PAH associated with congenital heart defects; and PAH associated with HIV. Subjects may be receiving prostacyclin or sildenafil therapy at baseline, and subjects who previously discontinued either bosentan, sitaxsentan, or both, due to liver function test abnormalities are eligible.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Summarized Inclusion Criteria:
Summarized Exclusion Criteria:
5. History of malignancies other than basal cell carcinoma of the skin or in situ carcinoma of the cervix within the past five years 6. Female subject who is pregnant or breastfeeding
Responsible Party: | Gilead Sciences, Inc. ( Kathleen DeHaven, Clinical Program Manager ) |
Study ID Numbers: | AMB-323, ARIES-3 |
Study First Received: | September 21, 2006 |
Last Updated: | June 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00380068 |
Health Authority: | United States: Food and Drug Administration |
Respiratory Tract Diseases Hypertension, Pulmonary Lung Diseases Vascular Diseases Hypertension |
Cardiovascular Diseases |