A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess Safety and Efficacy of Ambrisentan in Subjects With Pulmonary Arterial Hypertension.
This study has been completed.
Sponsor:
Gilead Sciences
Information provided by:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00423202
First received: January 17, 2007
Last updated: April 15, 2009
Last verified: April 2009
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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: Single Group 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:
Genetics Home Reference related topics:
pulmonary arterial hypertension
MedlinePlus related topics:
High Blood Pressure
Drug Information available for:
Ambrisentan
U.S. FDA Resources
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 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.
| Estimated Enrollment: | 186 |
| Study Start Date: | December 2003 |
| Estimated Study Completion Date: | October 2005 |
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 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
Contacts and Locations
No Contacts or Locations Provided
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00423202 History of Changes |
| Other Study ID Numbers: | AMB-321, ARIES-2 |
| Study First Received: | January 17, 2007 |
| Last Updated: | April 15, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hypertension, Pulmonary Hypertension Lung Diseases |
Respiratory Tract Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 21, 2013