Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00046319




Registration number
NCT00046319
Ethics application status
Date submitted
26/09/2002
Date registered
30/09/2002
Date last updated
16/04/2009

Titles & IDs
Public title
Study of BSF 208075 Evaluating Exercise Capacity in Patients With Pulmonary Arterial Hypertension
Scientific title
A Phase II, Randomized, Double-Blind, Dose-Controlled, Dose-Ranging, Multicenter Study of BSF 208075 Evaluating Exercise Capacity in Patients With Moderate to Severe Pulmonary Arterial Hypertension
Secondary ID [1] 0 0
AMB-220
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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline to Week 12 in six minute walk distance
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Change from baseline to Week 12 in:
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Borg Dyspnea Index
Timepoint [2] 0 0
Secondary outcome [3] 0 0
WHO Functional Classification
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Subject Global Assessment
Timepoint [4] 0 0

Eligibility
Key inclusion criteria
--Disease Characteristics--

* Current diagnosis of either PPH or PAH secondary to the scleroderma spectrum of disease (e.g., mixed connective tissue disease, systemic lupus erythematosus, systemic sclerosis, or overlap syndrome), anorexigen use, or human immunodeficiency virus (HIV) infection at the time of screening
* By means of a right heart catheterization, completed prior to Screening Visit subjects must meet all of the following hemodynamic criteria:

* Mean pulmonary arterial pressure of >/= 25 mmHg
* Pulmonary vascular resistance >3 mmHg/L/min
* Pulmonary capillary wedge pressure or left ventricle end diastolic pressure of <15 mmHg
* Stable on conventional therapy for PAH, including diuretics, digoxin, or supplemental oxygen, for at least one month prior to the Screening Visit
* Subjects with a diagnosis of HIV must have stable disease status at the time of screening. The subject may be enrolled if they meet the definition of a stable HIV status defined as:

* No addition of medications for treatment of HIV in the last two months
* No active opportunistic infection at the time of screening
* No hospitalizations due to HIV within the past four weeks
* Able to walk at least 150 meters, but no more than 450 meters, in a six minute walk test at the time of the Screening Visit
* No pulmonary arterial hypertension due to or associated with congenital heart disease, interstitial lung disease, chronic obstructive pulmonary disease, or chronic thrombotic and/or embolic disease, as documented by a historical echocardiogram, chest X-ray, ventilation/perfusion (V/Q) scan, and/or pulmonary arteriogram
* No subjects who have, as measured by a historical pulmonary function test:

* Total lung capacity (TLC) <70% of predicted normal or;
* Forced expiratory volume in one second (FEV1) <65% of predicted normal

--Other Criteria--

* Subjects are excluded if they have:

* A serum ALT or AST lab value that is greater than 1.5 times the upper limit of normal at any time during the Screening Period
* Contraindication to treatment with an endothelin receptor antagonist
* Demonstrated noncompliance with previous medical regimens
* A recent history of abusing alcohol or illicit drugs
* Participated in a clinical study involving another investigational drug or device within four weeks before the Screening Visit or at any time during the study

--Patient Characteristics--

* Women of childbearing potential must:

* Have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at the Randomization Visit. Women who are surgically sterile or those who are post-menopausal for at least two years are not considered to be of childbearing potential
* Agree to use a reliable double barrier method of contraception until study completion and for at least four weeks following their final study visit
* All males 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

Excluded:

* Pregnant or breastfeeding
* Have a history of malignancies within the past five years, with the exception of basal cell carcinoma of the skin or in situ carcinoma of the cervix
* Any other disease which, in the investigators opinion, may adversely affect the safety of the subject and/or efficacy of the study drug or severely limit the lifespan of the subject

--Prior/Concurrent Therapy--

* Stable on conventional therapy for PAH, including diuretics, digoxin, or supplemental oxygen, for at least one month prior to the Screening Visit

Excluded Therapies:

* IV inotropes within two weeks prior to the Screening Visit
* Chronic prostanoid therapy (epoprostenol, treprostinil, iloprost, beraprost, or any other investigational prostacyclin derivative) within four weeks prior to the Screening Visit
* Bosentan within four 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
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
1/09/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
St. Vincent's Hospital - Sidney
Recruitment postcode(s) [1] 0 0
- Sidney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Tennessee
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Wisconsin
Country [11] 0 0
Belgium
State/province [11] 0 0
Brussels
Country [12] 0 0
France
State/province [12] 0 0
Cedex
Country [13] 0 0
Germany
State/province [13] 0 0
Giessen
Country [14] 0 0
Germany
State/province [14] 0 0
Hannover
Country [15] 0 0
Italy
State/province [15] 0 0
Bologna

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
Lewis Rubin, MD
Address 0 0
UCSD Medical Center
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 not provided in https://clinicaltrials.gov/study/NCT00046319