Phase 2 Completed N=64 Treatment

Phase 2 Extension Study of Ambrisentan in Pulmonary Arterial Hypertension

Source: ClinicalTrials.gov NCT00424021 ↗

Enrolled (actual)

Serious AEs

59.3%

Results posted

Jan 2012

Primary outcomePrimary: 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 — 0; 1; 1; 0 Participants

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".

Outcome Measures

Outcome	Result	p-value
PRIMARY 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	0; 1; 1; 0; 0; 0	—
PRIMARY Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure	0; 1; 0; 1; 0; 0	—
PRIMARY Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure	0; 0; 1; 3; 0; 0	—
SECONDARY Baseline Measurement in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (Baseline [Week 24])	406.1	—
SECONDARY 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)	4.5	—
SECONDARY Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (LOCF) (Week 108)	-10.3	—
SECONDARY Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (LOCF) (Week 156)	-4.7	—
SECONDARY Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (LOCF) (Week 204)	-13.9	—
SECONDARY Baseline Measurement in Exercise Capacity as Measured by the Borg Dyspnea Index (BDI) (Baseline [Week 24])	2.69	—
SECONDARY Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the BDI (LOCF) (Week 48)	0.21	—
SECONDARY Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the BDI (LOCF) (Week 108)	0.46	—
SECONDARY Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the BDI (LOCF) (Week 156)	0.50	—
SECONDARY Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the BDI (LOCF) (Week 204)	0.46	—
SECONDARY Baseline Measurement in Exercise Capacity as Measured by the World Health Organization (WHO) Functional Classification (Baseline [Week 24])	8; 27; 19; 0	—
SECONDARY Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 24 Weeks of Treatment in AMB-220-E	7; 29; 18; 0	—
SECONDARY Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 84 Weeks of Treatment in AMB-220-E	5; 25; 21; 3	—
SECONDARY Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 132 Weeks of Treatment in AMB-220-E	10; 18; 24; 2	—
SECONDARY Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 180 Weeks of Treatment in AMB-220-E	10; 19; 23; 2	—
SECONDARY Baseline Measurement in Exercise Capacity as Measured by the Subject Global Assessment (SGA) (Baseline [Week 24])	69.5	—
SECONDARY Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the SGA (LOCF) (Week 48)	-0.6	—
SECONDARY Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the SGA (LOCF) (Week 108)	-7.4	—
SECONDARY Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the SGA (LOCF) (Week 156)	-5.1	—
SECONDARY Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the SGA (LOCF) (Week 204)	-1.9	—
SECONDARY Time to Clinical Worsening of PAH	78; 69; 60; 55	—
SECONDARY Failure-free Treatment Status	89; 77; 74; 70	—
SECONDARY Long-term Survival	94; 87; 87; 87	—

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00424021). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.