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A Long Term Study of Ambrisentan in Pulmonary Arterial Hypertension Subjects Having Completed AMB-320 (NCT00423748) or AMB-321 (NCT00423202)

Information source: Gilead Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Arterial Hypertension

Intervention: ambrisentan (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Gilead Sciences

Official(s) and/or principal investigator(s):
Chris Dufton, PhD, Study Chair, Affiliation: Gilead Sciences

Summary

AMB-320/321-E was designed to provide long-term, controlled monitoring of pulmonary arterial hypertension (PAH) patients treated with ambrisentan (AMB) in order to properly define the adverse event profile associated with this endothelin receptor antagonist (ERA), including the incidence and severity of elevated serum liver function tests (LFTs). In addition, this study continued the efficacy assessments of the previous studies, examined long-term AMB treatment success, and compared long-term survival of subjects treated with AMB to the NIH registry of patients with PAH.

Clinical Details

Official title: A Long Term Study of Ambrisentan in Pulmonary Arterial Hypertension Subjects Having Completed AMB-320 (NCT00423748) or AMB-321 (NCT00423202)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Frequently Reported (15% or More Overall) Adverse Events by Severity

Serum Aminotransferases Relative to the Upper Limit of the Normal Range (ULN)

Secondary outcome:

Baseline Exercise Capacity as Measured by the 6-Minute Walk Distance Test

Change From Baseline to Week 24 in Exercise Capacity as Measured by the 6-Minute Walk Distance Test

Change From Baseline to Week 48 (Year 1) in Exercise Capacity as Measured by the 6-Minute Walk Distance Test

Change From Baseline to Year 2 in Exercise Capacity as Measured by the 6-Minute Walk Distance Test

Change From Baseline to Year 3 in Exercise Capacity as Measured by the 6-Minute Walk Distance Test

Baseline Borg Dyspnea Index

Change From Baseline to Year 1 in Borg Dyspnea Index

Change From Baseline to Year 2 in Borg Dyspnea Index

Change From Baseline to Year 3 in Borg Dyspnea Index

Baseline World Health Organization (WHO) Functional Class

Change From Baseline to Year 1 in World Health Organization (WHO) Functional Class

Change From Baseline to Year 2 in World Health Organization (WHO) Functional Class

Change From Baseline to Year 3 in World Health Organization (WHO) Functional Class

Baseline SF-36 Health Survey Scales for the Combined Ambrisentan Group

Change From Baseline to Week 12 in SF-36 Health Survey Scales for the Combined Ambrisentan Group

Change From Baseline to Week 24 in SF-36 Health Survey Scales for the Combined Ambrisentan Group

Change From Baseline to Week 36 in SF-36 Health Survey Scales for the Combined Ambrisentan Group

Percentage of Participants With No Clinical Worsening of PAH

Percentage of Participants With Failure-Free Treatment Status

Long-term Survival

Detailed description: AMB-320 (ARIES-1; NCT00423748) and AMB-321 (ARIES-2; NCT00423202) were 12-week, Phase 3, randomized, double-blind, placebo-controlled, multicenter, efficacy studies of AMB in subjects with PAH. The objectives of these studies were to determine the effect of three doses of AMB (2. 5, 5. 0, and 10. 0 mg) on exercise capacity, as well as several clinical measures of PAH. The current study (NCT00578786) was unblinded (by design) prior to completion. The ARIES studies were identical except for the dose groups assessed and the geographic locations where the studies were conducted. Both studies evaluated placebo and 5. 0-mg AMB dose groups; however, AMB-320 (NCT00423748) also examined an AMB dose of 10. 0 mg, while AMB-321 (NCT00423202) included an AMB dose of 2. 5 mg. AMB-320/321-E was an optional study for subjects who had participated in AMB-320 (NCT00423748) or AMB-321 (NCT00423202) that allowed continued long-term treatment with AMB.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Subject must have completed Week 12 of AMB-320 (NCT00423748) or AMB-321 (NCT00423202) or must have received placebo during AMB-320 (NCT00423748) or AMB-321 (NCT00423202) 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 two reliable methods of contraception until study completion and for at least four weeks following their final study visit. Reliable methods include: birth control pills/implants/injections, intrauterine devices (IUDs), spermicide, diaphragms, or condoms. Exclusion Criteria:

- Subjects must have met the exclusion criteria of the AMB-320 (NCT00423748) and

AMB-321 (NCT00423202)studies. In addition, a subject who meets any one of the following criteria is ineligible for participation in the study: 1. Subject receiving bosentan, sildenafil, 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/RandomizationVisit; 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.

Locations and Contacts

Hospital Italiano de Cordoba, Cordoba X5004 FJE, Argentina

Hospital Privado Centro Medico de Cordoba, Cordoba X5016KEH, Argentina

Sanatorio Allende, Cordoba X5000JHQ, Argentina

Instituto de Cardiologia J.F. Cabral, Corrientes W3400AMZ, Argentina

Hospital Madre Teresa, Belo Horizonte 30380-090, Brazil

Complexo Hospitalar Sanata Casa de Porto Alegre, Porto Alegre 92020-090, Brazil

Hospital San Lucas de Pontificia Universidade Catolica, Porto Alegre 90610-000, Brazil

Hospital das Clinicas da FMUSP, Sao Paulo 05403-000, Brazil

Universidade do Estado de Sao Paulo - UNIFESP, Sao Paulo 04023-062, Brazil

Hospital Britanico-Buenos Aires, Ciudad Autonoma de Buenos Aires, Buenos Aires C1280AEB, Argentina

Instituto del Corazon Denton A. Cooley, Ciudad Autonoma de Buenos Aires, Buenos Aires C1416A, Argentina

Sanatorio Otamendi, Ciudad Autonoma de Buenos Aires, Buenos Aires C1115AAB, Argentina

UAI Hosp. Universitario, Ciudad Autonoma de Buenos Aires, Buenos Aires C1437BZL, Argentina

HIGA Hospital Interzonal General de Agudos Oscar Allende, Mar del Plata, Buenos Aires 07600, Argentina

Clinica Independencia Munro, Munro, Buenos Aires 01605, Argentina

Instituto Nacional de Cardiologia Ignacio Chavez, Mexico, DF, DF 14080, Mexico

Unidad De Investigacion Clinica en Medicina, Monterrey, Nuevo Leon, Nuevo Leon 64718, Mexico

Hospital Universitario Clementino Fraga Filho, Ilha do Fundao, Rio de Janeiro 21941-590, Brazil

Hospital Italiano de Rosario, Rosario, Sante Fe 02000, Argentina

Hospital Clinico Universidad Catolica, Santiago, Santiago de Chile CP 8350488, Chile

Hospital San Juan de Dios, Santiago, Santiago de Chile CP 8330024, Chile

Instituto Nacional del Torax, Santiago, Santiago de Chile CP7500691, Chile

Additional Information

Starting date: February 2004
Last updated: January 14, 2013

Page last updated: August 23, 2015

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