Phase 2 Extension Study of Ambrisentan in Pulmonary Arterial Hypertension

NCT00424021 | Completed Phase 2 Results

• 1 other identifier: AMB-220-E
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief Summary

AMB-220-E is an international, multicenter, open-label study examining the long-term safety of ambrisentan (BSF 208075) in subjects who have previously completed Myogen study NCT00046319, "A Phase II, Randomized, Double-Blind, Dose-Controlled, Dose-Ranging, Multicenter Study of BSF 208075 Evaluating Exercise Capacity in Subjects with Moderate to Severe Pulmonary Arterial Hypertension".

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure

  The number of participants in the AMB-220-E analysis set who experienced AEs (including serious AEs) of severe severity (ie, made it impossible to perform routine activities and the subject may have experienced intolerable discomfort or pain) that began after entering AMB-220-E (treatment-emergent AEs) and that occurred in more than 1 participant are summarized by dose group. The AMB-220-E analysis set consisted of all participants who received at least 1 dose of study drug during the AMB-220-E study.

  Week 24 (AMB-220-E baseline) to Week 334

• Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure

  The number of participants in the AMB-220-E analysis set who experienced AEs (including serious AEs) of moderate severity (ie, interfered with routine activities and subject may have experienced significant discomfort) that began after entering AMB-220-E (treatment-emergent AEs) and that occurred in more than 1 participant are summarized by dose group. The AMB-220-E analysis set consisted of all participants who received at least 1 dose of study drug during the AMB-220-E study.

  Week 24 (AMB-220-E baseline) to Week 329.3

• Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure

  The number of participants in the AMB-220-E analysis set who experienced AEs (including serious AEs) of mild severity (ie, did not interfere with routine activities and the subject may have experienced slight discomfort) that began after entering AMB-220-E (treatment-emergent AEs) and that occurred in more than 1 participant are summarized by dose group. The AMB-220-E analysis set consisted of all participants who received at least 1 dose of study drug during the AMB-220-E study.

  Week 24 (AMB-220-E baseline) to Week 329.3

Secondary Outcomes (23)

• Baseline Measurement in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (Baseline [Week 24])

  Week 24 (AMB-220-E baseline)

• Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (Last Observation Carried Forward [LOCF]) (Week 48)

  24 weeks (Week 24 to Week 48)

• Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (LOCF) (Week 108)

  84 weeks (Week 24 to Week 108)

• Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (LOCF) (Week 156)

  132 weeks (Week 24 to Week 156)

• Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (LOCF) (Week 204)

  180 weeks (Week 24 to Week 204)

Interventions

ambrisentan DRUG

1, 2.5, 5, and 10 mg ambrisentan given orally once daily

Also known as: BSF 208075, Letairis, Volibris

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have completed Visit 14/Week 24 of the NCT00046319 study.
• Women of childbearing potential must have a negative urine pregnancy test at the Screening/Enrollment Visit and agree to use a reliable double barrier method of contraception until study completion and for \>=4 weeks following their final study visit.
• Must have completed the Down-titration Period of NCT00046319 prior to enrollment in AMB-220-E and will meet the following additional criteria:
• Subjects with a diagnosis of HIV must have stable disease status at the time of Screening/Enrollment.
• Must be stable on conventional therapy for PAH for \>=4 weeks prior to the Screening Visit.

You may not qualify if:

• Chronic prostanoid therapy, or other investigational prostacyclin derivative within 4 weeks prior to the Screening Visit.
• Intravenous inotrope use within 2 weeks prior to the Screening Visit.
• Females who are pregnant or breastfeeding.
• Contraindication to treatment with an endothelin receptor antagonist (ERA).

Sponsors & Collaborators

• Gilead Sciences: lead

Related Links

• Pulmonary Hypertension Association

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

ambrisentan

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.

Results Point of Contact

• Title: Karen L Miller, PhD
• Organization: Gilead Sciences, Inc.

KarenL.Miller@gilead.com

650-524-3892

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2007
• First Posted: January 18, 2007
• Study Start: April 1, 2003
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: January 27, 2012
• Results First Posted: January 27, 2012

Record last verified: 2011-12