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

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

Condition(s) targeted: Hypertension, Pulmonary

Intervention: ambrisentan (Drug); tadalafil (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

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.

Clinical Details

Official title: AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)

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

Primary outcome: Number of Participants With First Adjudicated Clinical Failure (CF) Event, Death, Hospitalisation for Worsening PAH, Disease Progression, Unsatisfactory Long-term Clinical Response, All Through FAV

Secondary outcome:

Percent Change From Baseline in the N-Terminal Pro-B-Type Natriuretic Peptide at Week 24

Percentage of Participants With a Satisfactory Clinical Response at Week 24

Change From Baseline in the 6 Minute Walk Distance Test at Week 24

Change From Baseline in the World Health Organization Functional Class at Week 24

Change From Baseline in Borg Dyspnea Index at Week 24

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

GSK Investigational Site, Innsbruck A-6020, Austria

GSK Investigational Site, Vienna 1090, Austria

GSK Investigational Site, Brussels 1070, Belgium

GSK Investigational Site, Leuven 3000, Belgium

GSK Investigational Site, Brest 29200, France

GSK Investigational Site, Bron 69677, France

GSK Investigational Site, La Tronche 38700, France

GSK Investigational Site, Le Kremlin-Bicêtre cedex 94275, France

GSK Investigational Site, Lille 59037, France

GSK Investigational Site, Marseille cedex 20 13915, France

GSK Investigational Site, Montpellier cedex 5 34295, France

GSK Investigational Site, Pessac cedex 33604, France

GSK Investigational Site, Saint Pierre cedex 97448, France

GSK Investigational Site, Toulouse cedex 9 31059, France

GSK Investigational Site, Vandoeuvre-les-Nancy 54511, France

GSK Investigational Site, Berlin 12559, Germany

GSK Investigational Site, Hamburg 20246, Germany

GSK Investigational Site, Alexandroupolis 68100, Greece

GSK Investigational Site, Athens 176 74, Greece

GSK Investigational Site, Athens 124 62, Greece

GSK Investigational Site, Thessaloniki 54636, Greece

GSK Investigational Site, Fukuoka 812-8582, Japan

GSK Investigational Site, Hokkaido 060-8648, Japan

GSK Investigational Site, Shizuoka 431-3192, Japan

GSK Investigational Site, Tokyo 113-8655, Japan

GSK Investigational Site, Amsterdam 1081 HV, Netherlands

GSK Investigational Site, Maastricht 6229 HX, Netherlands

GSK Investigational Site, Rotterdam 3015 CE, Netherlands

GSK Investigational Site, Barcelona 08035, Spain

GSK Investigational Site, Barcelona 08036, Spain

GSK Investigational Site, Córdoba 14004, Spain

GSK Investigational Site, L'Hospitalet de Llobregat 08907, Spain

GSK Investigational Site, Madrid 28034, Spain

GSK Investigational Site, Madrid 28041, Spain

GSK Investigational Site, Majadahonda (Madrid) 28222, Spain

GSK Investigational Site, Malaga 29010, Spain

GSK Investigational Site, Palma de Mallorca 07010, Spain

GSK Investigational Site, Santander 39008, Spain

GSK Investigational Site, Santiago de Compostela 15706, Spain

GSK Investigational Site, Sevilla 41013, Spain

GSK Investigational Site, Toledo 45004, Spain

GSK Investigational Site, Valencia 46026, Spain

GSK Investigational Site, Göteborg SE-413 45, Sweden

GSK Investigational Site, Linköping SE-581 85, Sweden

GSK Investigational Site, Lund SE-221 85, Sweden

GSK Investigational Site, Umeå SE-901 85, Sweden

GSK Investigational Site, Uppsala SE-751 85, Sweden

GSK Investigational Site, Clydebank G81 4DY, United Kingdom

GSK Investigational Site, London NW3 2QH, United Kingdom

GSK Investigational Site, London SW3 6NP, United Kingdom

GSK Investigational Site, Sheffield S10 2JF, United Kingdom

GSK Investigational Site, Birmingham, Alabama 35294, United States

GSK Investigational Site, Mobile, Alabama 36617, United States

GSK Investigational Site, Calgary, Alberta T1Y 6J4, Canada

GSK Investigational Site, Phoenix, Arizona 85012, United States

GSK Investigational Site, Tucson, Arizona 85724, United States

GSK Investigational Site, Freiburg, Baden-Wuerttemberg 79106, Germany

GSK Investigational Site, Heidelberg, Baden-Wuerttemberg 69126, Germany

GSK Investigational Site, Loewenstein, Baden-Wuerttemberg 74245, Germany

GSK Investigational Site, Muenchen, Bayern 81377, Germany

GSK Investigational Site, Regensburg, Bayern 93053, Germany

GSK Investigational Site, Wuerzburg, Bayern 97074, Germany

GSK Investigational Site, Vancouver, British Columbia V5Z 1M9, Canada

GSK Investigational Site, La Jolla, California 92093, United States

GSK Investigational Site, Los Angeles, California 90073, United States

GSK Investigational Site, Sacramento, California 95817, United States

GSK Investigational Site, Torrance, California 90502, United States

GSK Investigational Site, Cambridge, Cambridgeshire CB3 8RE, United Kingdom

GSK Investigational Site, Aurora, Colorado 80045, United States

GSK Investigational Site, Bologna, Emilia-Romagna 40138, Italy

GSK Investigational Site, Gainesville, Florida 32610, United States

GSK Investigational Site, Jacksonville, Florida 32209, United States

GSK Investigational Site, Kissimmee, Florida 34741, United States

GSK Investigational Site, Orlando, Florida 32803, United States

GSK Investigational Site, Weston, Florida 33331, United States

GSK Investigational Site, Atlanta, Georgia 30322, United States

GSK Investigational Site, Decatur, Georgia 30030, United States

GSK Investigational Site, Giessen, Hessen 35392, Germany

GSK Investigational Site, Oakbrook Terrace, Illinois 60181, United States

GSK Investigational Site, Carmel, Indiana 46032, United States

GSK Investigational Site, Iowa City, Iowa 52242, United States

GSK Investigational Site, Kansas City, Kansas 66160, United States

GSK Investigational Site, Roma, Lazio 00161, Italy

GSK Investigational Site, New Orleans, Louisiana 70112, United States

GSK Investigational Site, Portland, Maine 04102, United States

GSK Investigational Site, Winnipeg, Manitoba R3A 1R8, Canada

GSK Investigational Site, Baltimore, Maryland 21201, United States

GSK Investigational Site, Boston, Massachusetts 02111, United States

GSK Investigational Site, Boston, Massachusetts 02115, United States

GSK Investigational Site, Boston, Massachusetts 02118, United States

GSK Investigational Site, Springfield, Massachusetts 01199, United States

GSK Investigational Site, Greifswald, Mecklenburg-Vorpommern 17475, Germany

GSK Investigational Site, Ann Arbor, Michigan 48109, United States

GSK Investigational Site, Detroit, Michigan 48201, United States

GSK Investigational Site, Troy, Michigan 48085, United States

GSK Investigational Site, St. Louis, Missouri 63110, United States

GSK Investigational Site, Omaha, Nebraska 68131, United States

GSK Investigational Site, Morristown, New Jersey 07962, United States

GSK Investigational Site, Newark, New Jersey 07112, United States

GSK Investigational Site, Camperdown, New South Wales 2050, Australia

GSK Investigational Site, Darlinghurst, New South Wales 2010, Australia

GSK Investigational Site, New Hyde Park, New York 11040, United States

GSK Investigational Site, New York, New York 10003, United States

GSK Investigational Site, New York, New York 10019, United States

GSK Investigational Site, New York, New York 10021, United States

GSK Investigational Site, New York, New York 10032, United States

GSK Investigational Site, Rochester, New York 14623, United States

GSK Investigational Site, Hannover, Niedersachsen 30625, Germany

GSK Investigational Site, Bonn, Nordrhein-Westfalen 53127, Germany

GSK Investigational Site, Koeln, Nordrhein-Westfalen 50937, Germany

GSK Investigational Site, Asheville, North Carolina 28803, United States

GSK Investigational Site, Chapel Hill, North Carolina 27599, United States

GSK Investigational Site, Cincinnati, Ohio 45219, United States

GSK Investigational Site, Cincinnati, Ohio 45267, United States

GSK Investigational Site, Cleveland, Ohio 44195, United States

GSK Investigational Site, Columbus, Ohio 43221, United States

GSK Investigational Site, Toronto, Ontario M5G 2N2, Canada

GSK Investigational Site, Portland, Oregon 97220, United States

GSK Investigational Site, Philadelphia, Pennsylvania 19104, United States

GSK Investigational Site, Philadelphia, Pennsylvania 19140, United States

GSK Investigational Site, Pittsburgh, Pennsylvania 15213, United States

GSK Investigational Site, Pittsburgh, Pennsylvania 15212, United States

GSK Investigational Site, Quebec City, Quebec G1V 4G5, Canada

GSK Investigational Site, Chermside, Queensland 4032, Australia

GSK Investigational Site, Providence, Rhode Island 02903, United States

GSK Investigational Site, Homburg, Saarland 66421, Germany

GSK Investigational Site, Dresden, Sachsen 01307, Germany

GSK Investigational Site, Leipzig, Sachsen 04103, Germany

GSK Investigational Site, Cagliari, Sardegna 09134, Italy

GSK Investigational Site, Catania, Sicilia 95100, Italy

GSK Investigational Site, Hobart, Tasmania 7000, Australia

GSK Investigational Site, Nashville, Tennessee 37232, United States

GSK Investigational Site, Dallas, Texas 75390, United States

GSK Investigational Site, Houston, Texas 77030, United States

GSK Investigational Site, Temple, Texas 76508, United States

GSK Investigational Site, Pisa, Toscana 56124, Italy

GSK Investigational Site, Murray, Utah 84157, United States

GSK Investigational Site, Melbourne, Victoria 3004, Australia

GSK Investigational Site, Charlottesville, Virginia 22908, United States

GSK Investigational Site, Norfolk, Virginia 23507, United States

GSK Investigational Site, Richmond, Virginia 23298, United States

GSK Investigational Site, Perth, Western Australia 6000, Australia

GSK Investigational Site, Milwaukee, Wisconsin 53215, United States

Additional Information

Starting date: October 2010
Last updated: May 28, 2015

Page last updated: August 23, 2015

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