Safety and Efficacy Study of Ambrisentan in Subjects With Pulmonary Hypertension - Full Text View

Sponsor:	Gilead Sciences
Information provided by:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT00380068

Purpose

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
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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure Pulmonary Hypertension

Drug Information available for: Ambrisentan

U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:

The primary endpoint of this study is the change from baseline in 6MWD. [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

A change from baseline in: WHO functional class, SF-36 health survey, Borg dyspnea index, B-type natriuretic peptide (BNP) [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
Monotherapy treatment status [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
Failure-free treatment status [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
Long-term survival [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
Worsening of pulmonary hypertension. [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	200
Study Start Date:	August 2006
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Oral tablets taken once daily.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Summarized Inclusion Criteria:

18 years of age or older
Current diagnosis of PH associated with an acceptable etiology as outlined in the protocol, including: IPAH, FPAH, PH associated with ILD, PH due to chronic thromboembolic disease or sickle cell disease, PH associated with COPD, and APAH secondary to the scleroderma spectrum of disease, systemic lupus, erythematosus, anorexigen use, congenital heart defects, or HIV infection
Stable regimen (within four weeks) of chronic prostanoid, PDE-5 inhibitor, calcium channel blocker, or HMG-CoA reductase inhibitor therapy
Right heart catheterization completed prior to screening must meet pre-specified criteria
Female subjects of childbearing potential must have a negative serum pregnancy test and must agree to use a reliable double method of contraception until study completion and for at least four weeks following their final study visit.
Male subjects must be informed of the potential risks of testicular tubular atrophy and infertility associated with taking ambrisentan and queried regarding his understanding of the potential risks as described in the Informed Consent Form.

Summarized Exclusion Criteria:

Participation in a previous clinical study with ambrisentan
Bosentan or sitaxsentan use within four weeks prior to the screening visit
AST or ALT lab value that is greater than 1.5 times the upper limit of normal at the screening visit
Pulmonary function tests not meeting pre-specified criteria
Contraindication to treatment with ERA

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00380068

Show 47 Study Locations

Sponsors and Collaborators

Gilead Sciences

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

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:	May 27, 2009
ClinicalTrials.gov Identifier:	NCT00380068 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Respiratory Tract Diseases
Hypertension, Pulmonary
Lung Diseases

Vascular Diseases
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on November 27, 2009