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

• Conditions: Pulmonary Arterial Hypertension

• Registration Number: EUCTR2005-001193-28-AT
• Lead Sponsor: Myogen, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10-04
• Last Update Posted: 22 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 372

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified