Phase 2 Extension Study of Ambrisentan in Pulmonary Arterial Hypertension - Full Text View

Sponsored by:	Myogen
Information provided by:	Myogen
ClinicalTrials.gov Identifier:	NCT00424021

Purpose

AMB-220-E is an international, multicenter, open-label study examining the long-term safety of ambrisentan in subjects who have previously completed Myogen study AMB-220, "A Phase II, Randomized, Double-Blind, Dose-Controlled, Dose-Ranging, Multicenter Study of BSF 208075 Evaluating Exercise Capacity in Subjects with Moderate to Severe Pulmonary Arterial Hypertension".

Condition	Intervention	Phase
Pulmonary Hypertension	Drug: ambrisentan	Phase II

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: Exercise and Physical Fitness High Blood Pressure Pulmonary Hypertension

Drug Information available for: Ambrisentan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label, Long-Term Study of Ambrisentan in Pulmonary Hypertension Subjects Having Completed Myogen Study AMB-220

Further study details as provided by Myogen:

Primary Outcome Measures:

Incidence and severity of adverse events associated with long-term exposure of ambrisentan in patients with PAH who have completed the Phase II AMB-220 study.

Secondary Outcome Measures:

Change from baseline in exercise capacity as measured by the 6-minute walk test distance; Borg Dyspnea Index; WHO Functional Classification, Subject Global Assessment; clinical worsening of PAH; failure-free treatment status
and long-term survival.

Estimated Enrollment:	60
Study Start Date:	April 2003

Eligibility

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

Criteria

Inclusion Criteria:

Must have completed Visit 14/Week 24 of the AMB-220 study.
Women of childbearing potential must have a negative urine pregnancy test at the Screening/Enrollment Visit and agree to use a reliable double barrier method of contraception until study completion and for at least four weeks following their final study visit.
Must have completed the Down-titration Period of AMB-220 prior to enrollment in AMB-220-E and will meet the following additional criteria:
Subjects with a diagnosis of HIV must have stable disease status at the time of Screening/Enrollment.
Must be stable on conventional therapy for PAH for at least four weeks prior to the Screening Visit.

Exclusion Criteria:

Chronic prostanoid therapy, or other investigational prostacyclin derivative within four weeks prior to the Screening Visit.
IV inotrope use within two weeks prior to the Screening Visit.
Females who are pregnant or breastfeeding.
Contraindication to treatment with an ERA (endothelin receptor antagonist).

Contacts and Locations

No Contacts or Locations Provided

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	AMB-220-E
Study First Received:	January 17, 2007
Last Updated:	January 17, 2007
ClinicalTrials.gov Identifier:	NCT00424021
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Idiopathic pulmonary hypertension
Respiratory Tract Diseases
Hypertension, Pulmonary

Lung Diseases
Vascular Diseases
Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009