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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess Safety and Efficacy of Ambrisentan in Subjects With Pulmonary Arterial Hypertension.

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ClinicalTrials.gov Identifier: NCT00423202
Recruitment Status : Completed
First Posted : January 18, 2007
Last Update Posted : April 16, 2009
Information provided by:
Gilead Sciences

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

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: ambrisentan Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
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.
Study Start Date : December 2003
Study Completion Date : October 2005

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

Secondary Outcome Measures :
  1. Change from baseline measured after 12 weeks of treatment compared to placebo in the Borg Dyspnea Index immediately following exercise, WHO functional class and SF-36 Health Survey.
  2. Clinical worsening of PAH.
  3. Assessment of the safety and tolerability of the study drug.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18 years of age and older
  • Current diagnosis of either PPH or PAH 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
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ClinicalTrials.gov Identifier: NCT00423202    
Other Study ID Numbers: AMB-321
First Posted: January 18, 2007    Key Record Dates
Last Update Posted: April 16, 2009
Last Verified: April 2009
Additional relevant MeSH terms:
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Pulmonary Arterial Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Antihypertensive Agents