ARIES-320/321-E “A Long-Term Study of Ambrisentan in Pulmonary Arterial Hypertension Subjects Having Completed AMB-320 or AMB-321" - 320/321-E

• Register: EUCTR
• Last refreshed on: 22 April 2013
• Main ID: EUCTR2005-001193-28-AT
• Date of registration: 04/10/2005
• Prospective Registration: Yes
• Primary sponsor: Myogen, Inc
• Public title: ARIES-320/321-E “A Long-Term Study of Ambrisentan in Pulmonary Arterial Hypertension Subjects Having Completed AMB-320 or AMB-321" - 320/321-E
• Scientific title: ARIES-320/321-E “A Long-Term Study of Ambrisentan in Pulmonary Arterial Hypertension Subjects Having Completed AMB-320 or AMB-321" - 320/321-E
• Date of first enrolment: 08/11/2005
• Target sample size: 372
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-001193-28
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Austria

Key inclusion & exclusion criteria

Inclusion criteria:
In order to be considered eligible, a subject must meet all of the following criteria:

1. Subject must have completed Week 12 of AMB-320 or AMB-321 or must have received placebo during AMB-320 or AMB-321 and met two or more early escape criteria;
2. Subject must be competent to understand the information given in the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approved informed consent form and must sign the form prior to the initiation of any study procedures.
3. Female subject of childbearing potential must agree to use a reliable double barrier method of contraception until study completion and for at least four weeks following their final study visit. A reliable double barrier method of contraception is considered to be a combination of TWO of the following: birth control pills/implants/injections, intrauterine devices (IUDs), spermicide, diaphragms, or condoms.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Subjects must have met the exclusion criteria of the AMB-320 and AMB-321 studies.

In addition, a subject who meets any one of the following criteria is ineligible for participation in the study:

1. Subject receiving bosentan, phosphodiesterase type V inhibitors (sildenafil, vardenafil, tadalafil, etc.), or iv inotropes at any time within four weeks prior to the AMB-320/321-E Screening/Randomization Visit;
2. Subject receiving chronic prostanoid therapy (epoprostenol, treprostinil, iloprost, beraprost, or any other investigational prostacyclin derivative) within four weeks prior to the AMB-320/321-E Screening/Randomization Visit;
3. Female subject who is pregnant or breastfeeding;
4. Subject with cardiovascular, liver, renal, hematologic, gastrointestinal, immunologic, endocrine, metabolic, or central nervous system disease that, in the opinion of the Investigator, may adversely affect the safety of the subject and/or efficacy of the study drug or severely limit the lifespan of the subject;
5. Subject who has demonstrated noncompliance with previous medical regimens;
6. Subject who has a recent history of abusing alcohol or illicit drugs;
7. Subject who has participated in a clinical study involving another investigational drug or device at any time within four weeks prior to the AMB-320/321-E Screening/Randomization Visit.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Pulmonary Arterial Hypertension

Intervention(s)

Product Name: Ambrisentan
Product Code: BSF 208075
Pharmaceutical Form: Tablet
INN or Proposed INN: Ambrisentan
CAS Number: 177036-94-1
Current Sponsor code: BSF 208075
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.0-

Product Name: Ambrisentan
Product Code: BSF 208075
Pharmaceutical Form: Tablet
INN or Proposed INN: Ambrisentan
CAS Number: 177036-94-1
Current Sponsor code: BSF 208075
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-

Product Name: Ambrisentan
Product Code: BSF 208075
Pharmaceutical Form: Tablet
INN or Proposed INN: Ambrisentan
CAS Number: 177036-94-1
Current Sponsor code: BSF 208075
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5.0-

Product Name: Ambrisentan
Product Code: BSF 208075
Pharmaceutical Form: Tablet
INN or Proposed INN: Ambrisentan
CAS Number: 177036-94-1
Current Sponsor code: BSF 208075
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10.0-

Primary Outcome(s)

Main Objective: The objective of this study is to evaluate the long-term safety of ambrisentan in patients with PAH and to explore the long-term safety of the initiation of prostacyclin therapy in PAH patients receiving ambrisentan.

Primary end point(s): The primary endpoint of this study is the incidence and severity of adverse events associated with long-term exposure to ambrisentan in subjects with PAH.

The secondary endpoints include:

1. A change from baseline in the:
• Exercise capacity as measured by distance traveled in the six-minute walk test;
• Borg Dyspnea Index immediately following exercise;
• WHO Functional Class;
• SF-36™ Health Survey;

2. Clinical worsening of PAH, as defined by the time from initiation of active treatment to the first occurrence of death, lung transplantation, hospitalization for PAH, atrial septostomy, the addition of approved prostanoid therapy, or study withdrawal due to the addition of other clinically approved PAH therapeutic agents;

3. Failure-free treatment status, as defined by the time from initiation of active treatment to the first occurrence of death, lung transplantation, the addition of approved prostanoid therapy, or study withdrawal due to the addition of other clinically approved PAH therapeutic agents;

4. Long-term survival, as defined by the time from initiation of active treatment to death, compared to predicted NIH estimates.

Secondary Objective: In addition, this study will continue the efficacy assessments of the previous studies, examine long-term ambrisentan treatment success, and compare long-term survival of subjects treated with ambrisentan to the NIH registry of patients with PAH.

Secondary ID(s)

AMB-320/321-E