Study to Assess Safety and Efficacy of Ambrisentan in Subjects With Pulmonary Arterial Hypertension.

This study has been completed.
Sponsor:
Information provided by:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00423748
First received: January 17, 2007
Last updated: April 15, 2009
Last verified: April 2009
  Purpose

A phase 3, randomized, double-blind, placebo-controlled study to assess safety and efficacy of ambrisentan in subjects with pulmonary arterial hypertension.


Condition Intervention Phase
Pulmonary Arterial Hypertension
Drug: ambrisentan
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Ambrisentan in PAH - A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects With Pulmonary Arterial Hypertension

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Change from baseline in the six-minute walk distance evaluated after 12 weeks of therapy compared to placebo.

Secondary Outcome Measures:
  • Change from baseline measured after 12 weeks of treatment compared to placebo in the Borg Dyspnea Index; WHO Functional Classification; and the SF-36 Health Survey.
  • Clinical worsening of PAH.
  • Assessment of the safety and tolerability of the study drug.

Estimated Enrollment: 186
Study Start Date: December 2003
Estimated Study Completion Date: February 2006
Detailed Description:

Subjects in these randomized studies will receive one of two doses of ambrisentan or placebo. Inclusion is not based on a specified WHO functional classification. Rather, subjects with WHO Class I-IV symptoms are eligible if their 6-minute walk distance is 150-450 meters and they meet the study-specified hemodynamic criteria. Subjects with anorexigen or HIV infection related PAH are eligible but subjects with congenital heart disease and pediatric subjects are excluded. The study requires a historical cardiac catheterization and other diagnostic procedures.

  Eligibility

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

Inclusion Criteria:

  • 18 years of age or order
  • Current diagnosis of either PPH orPAH secondary to the scleroderma spectrum of disease, systemic lupus erythematosus, anorexigen use, or HIV infection at the Screening Visit
  • Right heart catheterization, completed prior to Screening Visit must meet pre-specified hemodynamic criteria
  • Female subjects of childbearing potential must have a negative serum pregnancy test and must agree to use a reliable double barrier 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 this study drug and queried regarding his understanding of the potential risks as described in the Informed Consent Form

Exclusion Criteria:

  • PAH due to or associated with congenital heart disease, coronary artery disease, left heart disease, interstitial lung disease, chronic obstructive pulmonary disease, veno-occlusive disease, chronic thrombotic and/or embolic disease, or sleep apnea
  • Portopulmonary hypertension
  • Bosentan within four weeks prior to Screening
  • Phosphodiesterase type V inhibitor or chronic prostanoid therapy within four weeks prior to Screening
  • IV inotrope use within two weeks prior to Screening
  • ALT or AST lab value that is greater than 1.5 times the upper limit of normal
  • Pulmonary function tests not meeting pre-specified criteria
  • Contraindication to treatment with an ERA
  • History of malignancies other than basal cell carcinoma of the skin or in situ carcinoma of the cervix within the past five years
  • Females who are pregnant or breastfeeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00423748     History of Changes
Other Study ID Numbers: AMB-320, ARIES-1
Study First Received: January 17, 2007
Last Updated: April 15, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014