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

Primary Purpose

Pulmonary Arterial Hypertension

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ambrisentan
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    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.

    Full Information

    First Posted
    January 17, 2007
    Last Updated
    April 15, 2009
    Sponsor
    Gilead Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00423748
    Brief Title
    Study to Assess Safety and Efficacy of Ambrisentan in Subjects With Pulmonary Arterial Hypertension.
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    February 2006 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Gilead Sciences

    4. Oversight

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulmonary Arterial Hypertension

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    186 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    ambrisentan
    Primary Outcome Measure Information:
    Title
    Change from baseline in the six-minute walk distance evaluated after 12 weeks of therapy compared to placebo.
    Secondary Outcome Measure Information:
    Title
    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.
    Title
    Clinical worsening of PAH.
    Title
    Assessment of the safety and tolerability of the study drug.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Learn more about this trial

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

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