Back to resultsA Phase 3, Randomized, Double-Blind, Placebo-Controlled 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
About this trial
This is an interventional treatment trial for Pulmonary Arterial Hypertension
Eligibility Criteria
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
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 immediately following exercise, WHO functional class and SF-36 Health Survey.
Clinical worsening of PAH.
Assessment of the safety and tolerability of the study drug.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00423202
Brief Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled 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
October 2005 (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.
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
Single Group 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 immediately following exercise, WHO functional class and 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 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
12. IPD Sharing Statement
Learn more about this trial
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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