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A Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)

NCT ID: NCT01178073

Last Updated: 2017-09-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

610 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-01

Study Completion Date

2014-07-31

Brief Summary

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The purpose of this study is to compare the two treatment strategies; first-line combination therapy (ambrisentan and tadalafil) versus first-line monotherapy (ambrisentan or tadalafil) in subjects with Pulmonary Arterial Hypertension. This will be assessed by time to the first clinical failure event.

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Detailed Description

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Conditions

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Hypertension, Pulmonary

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Combination ambrisentan + tadalafil

ambrisentan + tadalafil

Group Type ACTIVE_COMPARATOR

ambrisentan

Intervention Type DRUG

ambrisentan (target dose: 10mg)

tadalafil

Intervention Type DRUG

tadalafil (target dose: 40mg)

Monotherapy ambrisentan

ambrisentan

Group Type ACTIVE_COMPARATOR

ambrisentan

Intervention Type DRUG

ambrisentan (target dose: 10mg)

Monotherapy tadalafil

tadalafil

Group Type ACTIVE_COMPARATOR

tadalafil

Intervention Type DRUG

tadalafil (target dose: 40mg)

Interventions

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ambrisentan

ambrisentan (target dose: 10mg)

Intervention Type DRUG

tadalafil

tadalafil (target dose: 40mg)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects must have a diagnosis of Pulmonary Arterial Hypertension (PAH) due to the following:

a. idiopathic or heritable PAH b. PAH associated with: i. connective tissue disease (e.g., limited scleroderma, diffuse scleroderma, mixed connective tissue disease, systemic lupus erythematosus, or overlap syndrome) ii. drugs or toxins iii. Human Immunodeficiency Virus (HIV) infection iv. congenital heart defects repaired greater than 1 year prior to screening (i.e., atrial septal defects, ventricular septal defects, and patent ductus arteriosus) NB: subjects with portopulmonary hypertension and pulmonary veno-occlusive disease are NOT eligible for the study
* Subject must have a current diagnosis of being in World Health Organisation (WHO) Functional Class II or III.
* Subject must meet all of the following haemodynamic criteria by means of a right heart catheterization prior to screening:

i. mPAP of ≥25 mmHg ii. PVR ≥ 300 dynes/sec/cm5 iii. PCWP or LVEDP of ≤12 mmHg if PVR ≥300 to \<500 dyne/sec/cm5 , or PCWP/LVEDP ≤ 15 mmHg if PVR ≥500 dynes/sec/cm5
* Subject must walk a distance of ≥125m and ≤500m at the screening visit

Exclusion Criteria

* Subject received previous PAH therapy (phosphodiesterase type 5 inhibitor (PDE5i), endothelin receptor antagonist (ERA), chronic prostanoid\*) within 4 weeks prior to the screening visit (\*Chronic prostanoid use is considered \>7 days of treatment)
* Subject received ERA treatment (e.g., bosentan or sitaxentan) or PDE5i treatment (e.g. Sildenafil) at any time AND discontinued due to tolerance issues other than those associated with liver function abnormalities
* Subjects who have previously discontinued ambrisentan or tadalafil in either another clinical study or commercial product (Volibris/Letairis or Adcirca) for safety or tolerability reasons.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Birmingham, Alabama, United States

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Mobile, Alabama, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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La Jolla, California, United States

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Los Angeles, California, United States

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Sacramento, California, United States

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Torrance, California, United States

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Aurora, Colorado, United States

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Gainesville, Florida, United States

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Jacksonville, Florida, United States

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Kissimmee, Florida, United States

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Orlando, Florida, United States

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Weston, Florida, United States

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Atlanta, Georgia, United States

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Decatur, Georgia, United States

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Oakbrook Terrace, Illinois, United States

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Carmel, Indiana, United States

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Iowa City, Iowa, United States

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Kansas City, Kansas, United States

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New Orleans, Louisiana, United States

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Portland, Maine, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Springfield, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Detroit, Michigan, United States

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Troy, Michigan, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Morristown, New Jersey, United States

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Newark, New Jersey, United States

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New Hyde Park, New York, United States

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New York, New York, United States

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New York, New York, United States

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New York, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Asheville, North Carolina, United States

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Chapel Hill, North Carolina, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Providence, Rhode Island, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Temple, Texas, United States

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Murray, Utah, United States

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Charlottesville, Virginia, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Milwaukee, Wisconsin, United States

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Camperdown, New South Wales, Australia

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Darlinghurst, New South Wales, Australia

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Chermside, Queensland, Australia

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Hobart, Tasmania, Australia

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Melbourne, Victoria, Australia

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Perth, Western Australia, Australia

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Innsbruck, , Austria

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Vienna, , Austria

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Brussels, , Belgium

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Leuven, , Belgium

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Calgary, Alberta, Canada

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Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Toronto, Ontario, Canada

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Québec, Quebec, Canada

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Brest, , France

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Bron, , France

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La Tronche, , France

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Le Kremlin-Bicêtre, , France

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Lille, , France

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Marseille, , France

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Montpellier, , France

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Pessac, , France

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Saint-Pierre, , France

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Toulouse, , France

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Vandœuvre-lès-Nancy, , France

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Freiburg im Breisgau, Baden-Wurttemberg, Germany

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Heidelberg, Baden-Wurttemberg, Germany

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Löwenstein, Baden-Wurttemberg, Germany

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Munich, Bavaria, Germany

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Regensburg, Bavaria, Germany

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Würzburg, Bavaria, Germany

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Giessen, Hesse, Germany

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Hanover, Lower Saxony, Germany

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Greifswald, Mecklenburg-Vorpommern, Germany

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Bonn, North Rhine-Westphalia, Germany

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Cologne, North Rhine-Westphalia, Germany

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Homburg, Saarland, Germany

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Dresden, Saxony, Germany

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Leipzig, Saxony, Germany

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Berlin, , Germany

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Hamburg, , Germany

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Alexandroupoli, , Greece

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Athens, , Greece

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Athens, , Greece

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Thessaloniki, , Greece

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Bologna, Emilia-Romagna, Italy

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Rome, Lazio, Italy

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Cagliari, Sardinia, Italy

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Catania, Sicily, Italy

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Pisa, Tuscany, Italy

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Fukuoka, , Japan

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Hokkaido, , Japan

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Shizuoka, , Japan

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Tokyo, , Japan

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Amsterdam, , Netherlands

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Maastricht, , Netherlands

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Rotterdam, , Netherlands

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Barcelona, , Spain

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Barcelona, , Spain

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Córdoba, , Spain

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L'Hospitalet de Llobregat, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Majadahonda (Madrid), , Spain

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Málaga, , Spain

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Palma de Mallorca, , Spain

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Santander, , Spain

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Santiago de Compostela, , Spain

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Seville, , Spain

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Toledo, , Spain

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Valencia, , Spain

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Gothenburg, , Sweden

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Linköping, , Sweden

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Lund, , Sweden

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Umeå, , Sweden

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Uppsala, , Sweden

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Cambridge, Cambridgeshire, United Kingdom

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Clydebank, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Sheffield, , United Kingdom

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Countries

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United States Australia Austria Belgium Canada France Germany Greece Italy Japan Netherlands Spain Sweden United Kingdom

References

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Kuwana M, Blair C, Takahashi T, Langley J, Coghlan JG. Initial combination therapy of ambrisentan and tadalafil in connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH) in the modified intention-to-treat population of the AMBITION study: post hoc analysis. Ann Rheum Dis. 2020 May;79(5):626-634. doi: 10.1136/annrheumdis-2019-216274. Epub 2020 Mar 11.

Reference Type DERIVED
PMID: 32161055 (View on PubMed)

White RJ, Vonk-Noordegraaf A, Rosenkranz S, Oudiz RJ, McLaughlin VV, Hoeper MM, Grunig E, Ghofrani HA, Chakinala MM, Barbera JA, Blair C, Langley J, Frost AE. Clinical outcomes stratified by baseline functional class after initial combination therapy for pulmonary arterial hypertension. Respir Res. 2019 Sep 12;20(1):208. doi: 10.1186/s12931-019-1180-1.

Reference Type DERIVED
PMID: 31511080 (View on PubMed)

Coghlan JG, Galie N, Barbera JA, Frost AE, Ghofrani HA, Hoeper MM, Kuwana M, McLaughlin VV, Peacock AJ, Simonneau G, Vachiery JL, Blair C, Gillies H, Miller KL, Harris JHN, Langley J, Rubin LJ; AMBITION investigators. Initial combination therapy with ambrisentan and tadalafil in connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH): subgroup analysis from the AMBITION trial. Ann Rheum Dis. 2017 Jul;76(7):1219-1227. doi: 10.1136/annrheumdis-2016-210236. Epub 2016 Dec 30.

Reference Type DERIVED
PMID: 28039187 (View on PubMed)

Galie N, Barbera JA, Frost AE, Ghofrani HA, Hoeper MM, McLaughlin VV, Peacock AJ, Simonneau G, Vachiery JL, Grunig E, Oudiz RJ, Vonk-Noordegraaf A, White RJ, Blair C, Gillies H, Miller KL, Harris JH, Langley J, Rubin LJ; AMBITION Investigators. Initial Use of Ambrisentan plus Tadalafil in Pulmonary Arterial Hypertension. N Engl J Med. 2015 Aug 27;373(9):834-44. doi: 10.1056/NEJMoa1413687.

Reference Type DERIVED
PMID: 26308684 (View on PubMed)

Peacock AJ, Zamboni W, Vizza CD. Ambrisentan for the treatment of adults with pulmonary arterial hypertension: a review. Curr Med Res Opin. 2015;31(9):1793-807. doi: 10.1185/03007995.2015.1074890. Epub 2015 Aug 27.

Reference Type DERIVED
PMID: 26196225 (View on PubMed)

Other Identifiers

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112565

Identifier Type: -

Identifier Source: org_study_id

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