Clinical trial NCT00424021: Phase 2 Extension Study of Ambrisentan in Pulmonary Arterial Hypertension
Official title: An Open-Label, Long-Term Study of Ambrisentan in Pulmonary Hypertension Subjects Having Completed Myogen Study AMB-220
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Hypertension
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2007-01-18
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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".


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).

Primary outcomes:
measure: 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
timeFrame: Week 24 (AMB-220-E baseline) to Week 334
measure: Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure
timeFrame: Week 24 (AMB-220-E baseline) to Week 329.3
measure: Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure
timeFrame: Week 24 (AMB-220-E baseline) to Week 329.3
Secondary outcomes:
measure: Baseline Measurement in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (Baseline [Week 24])
timeFrame: Week 24 (AMB-220-E baseline)
measure: 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)
timeFrame: 24 weeks (Week 24 to Week 48)
measure: Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (LOCF) (Week 108)
timeFrame: 84 weeks (Week 24 to Week 108)
measure: Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (LOCF) (Week 156)
timeFrame: 132 weeks (Week 24 to Week 156)
measure: Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (LOCF) (Week 204)
timeFrame: 180 weeks (Week 24 to Week 204)
measure: Baseline Measurement in Exercise Capacity as Measured by the Borg Dyspnea Index (BDI) (Baseline [Week 24])
timeFrame: Week 24 (AMB-220-E baseline)
measure: Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the BDI (LOCF) (Week 48)
timeFrame: 24 weeks (Week 24 to Week 48)
measure: Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the BDI (LOCF) (Week 108)
timeFrame: 84 weeks (Week 24 to Week 108)
measure: Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the BDI (LOCF) (Week 156)
timeFrame: 132 weeks (Week 24 to Week 156)
measure: Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the BDI (LOCF) (Week 204)
timeFrame: 180 weeks (Week 24 to Week 204)
measure: Baseline Measurement in Exercise Capacity as Measured by the World Health Organization (WHO) Functional Classification (Baseline [Week 24])
timeFrame: Week 24 (AMB-220-E baseline)
measure: Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 24 Weeks of Treatment in AMB-220-E
timeFrame: 24 weeks (Week 24 [baseline of AMB-220-E] to Week 48)
measure: Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 84 Weeks of Treatment in AMB-220-E
timeFrame: 84 weeks (Week 24 of NCT00046319 to Week 108)
measure: Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 132 Weeks of Treatment in AMB-220-E
timeFrame: 132 weeks (Week 24 of NCT00046319 to Week 156)
measure: Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 180 Weeks of Treatment in AMB-220-E
timeFrame: 180 weeks (Week 24 of NCT00046319 to Week 204)
measure: Baseline Measurement in Exercise Capacity as Measured by the Subject Global Assessment (SGA) (Baseline [Week 24])
timeFrame: Week 24 (AMB-220-E baseline)
measure: Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the SGA (LOCF) (Week 48)
timeFrame: 24 weeks (Week 24 to Week 48)
measure: Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the SGA (LOCF) (Week 108)
timeFrame: 84 weeks (Week 24 to Week 108)
measure: Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the SGA (LOCF) (Week 156)
timeFrame: 132 weeks (Week 24 to Week 156)
measure: Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the SGA (LOCF) (Week 204)
timeFrame: 180 weeks (Week 24 to Week 204)
measure: Time to Clinical Worsening of PAH
timeFrame: Week 0 (NCT00046319 baseline) to Week 360
measure: Failure-free Treatment Status
timeFrame: Week 0 (NCT00046319 baseline) to Week 360
measure: Long-term Survival
timeFrame: Week 24 (AMB-220-E baseline) to Week 329.3
Other outcomes:
Locations:
Study officials:
References: