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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00424021




Registration number
NCT00424021
Ethics application status
Date submitted
17/01/2007
Date registered
18/01/2007
Date last updated
27/01/2012

Titles & IDs
Public title
Phase 2 Extension Study of Ambrisentan in Pulmonary Arterial Hypertension
Scientific title
An Open-Label, Long-Term Study of Ambrisentan in Pulmonary Hypertension Subjects Having Completed Myogen Study AMB-220
Secondary ID [1] 0 0
AMB-220-E
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Hypertension 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ambrisentan

Treatment: Drugs: ambrisentan
1, 2.5, 5, and 10 mg ambrisentan given orally once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Week 24 (AMB-220-E baseline) to Week 334
Primary outcome [2] 0 0
Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure
Timepoint [2] 0 0
Week 24 (AMB-220-E baseline) to Week 329.3
Primary outcome [3] 0 0
Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure
Timepoint [3] 0 0
Week 24 (AMB-220-E baseline) to Week 329.3
Secondary outcome [1] 0 0
Baseline Measurement in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (Baseline [Week 24])
Timepoint [1] 0 0
Week 24 (AMB-220-E baseline)
Secondary outcome [2] 0 0
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)
Timepoint [2] 0 0
24 weeks (Week 24 to Week 48)
Secondary outcome [3] 0 0
Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (LOCF) (Week 108)
Timepoint [3] 0 0
84 weeks (Week 24 to Week 108)
Secondary outcome [4] 0 0
Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (LOCF) (Week 156)
Timepoint [4] 0 0
132 weeks (Week 24 to Week 156)
Secondary outcome [5] 0 0
Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (LOCF) (Week 204)
Timepoint [5] 0 0
180 weeks (Week 24 to Week 204)
Secondary outcome [6] 0 0
Baseline Measurement in Exercise Capacity as Measured by the Borg Dyspnea Index (BDI) (Baseline [Week 24])
Timepoint [6] 0 0
Week 24 (AMB-220-E baseline)
Secondary outcome [7] 0 0
Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the BDI (LOCF) (Week 48)
Timepoint [7] 0 0
24 weeks (Week 24 to Week 48)
Secondary outcome [8] 0 0
Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the BDI (LOCF) (Week 108)
Timepoint [8] 0 0
84 weeks (Week 24 to Week 108)
Secondary outcome [9] 0 0
Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the BDI (LOCF) (Week 156)
Timepoint [9] 0 0
132 weeks (Week 24 to Week 156)
Secondary outcome [10] 0 0
Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the BDI (LOCF) (Week 204)
Timepoint [10] 0 0
180 weeks (Week 24 to Week 204)
Secondary outcome [11] 0 0
Baseline Measurement in Exercise Capacity as Measured by the World Health Organization (WHO) Functional Classification (Baseline [Week 24])
Timepoint [11] 0 0
Week 24 (AMB-220-E baseline)
Secondary outcome [12] 0 0
Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 24 Weeks of Treatment in AMB-220-E
Timepoint [12] 0 0
24 weeks (Week 24 [baseline of AMB-220-E] to Week 48)
Secondary outcome [13] 0 0
Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 84 Weeks of Treatment in AMB-220-E
Timepoint [13] 0 0
84 weeks (Week 24 of NCT00046319 to Week 108)
Secondary outcome [14] 0 0
Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 132 Weeks of Treatment in AMB-220-E
Timepoint [14] 0 0
132 weeks (Week 24 of NCT00046319 to Week 156)
Secondary outcome [15] 0 0
Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 180 Weeks of Treatment in AMB-220-E
Timepoint [15] 0 0
180 weeks (Week 24 of NCT00046319 to Week 204)
Secondary outcome [16] 0 0
Baseline Measurement in Exercise Capacity as Measured by the Subject Global Assessment (SGA) (Baseline [Week 24])
Timepoint [16] 0 0
Week 24 (AMB-220-E baseline)
Secondary outcome [17] 0 0
Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the SGA (LOCF) (Week 48)
Timepoint [17] 0 0
24 weeks (Week 24 to Week 48)
Secondary outcome [18] 0 0
Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the SGA (LOCF) (Week 108)
Timepoint [18] 0 0
84 weeks (Week 24 to Week 108)
Secondary outcome [19] 0 0
Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the SGA (LOCF) (Week 156)
Timepoint [19] 0 0
132 weeks (Week 24 to Week 156)
Secondary outcome [20] 0 0
Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the SGA (LOCF) (Week 204)
Timepoint [20] 0 0
180 weeks (Week 24 to Week 204)
Secondary outcome [21] 0 0
Time to Clinical Worsening of PAH
Timepoint [21] 0 0
Week 0 (NCT00046319 baseline) to Week 360
Secondary outcome [22] 0 0
Failure-free Treatment Status
Timepoint [22] 0 0
Week 0 (NCT00046319 baseline) to Week 360
Secondary outcome [23] 0 0
Long-term Survival
Timepoint [23] 0 0
Week 24 (AMB-220-E baseline) to Week 329.3

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2009
Sample size
Target
Accrual to date
Final
54
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00424021