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



Status:Completed
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 75
Updated:1/1/2014
Start Date:October 2010
End Date:August 2013
Contact:US GSK Clinical Trials Call Center
Email:GSKClinicalSupportHD@gsk.com
Phone:877-379-3718

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

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.


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.
We found this trial at
54
sites
Springfield, Massachusetts 01199
2500
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Springfield, MA
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Ann Arbor, Michigan 48109
1934
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Asheville, North Carolina 28803
2003
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Asheville, NC
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Atlanta, Georgia 30341
1922
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Atlanta, GA
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Aurora, Colorado 80010
824
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Baltimore, Maryland 21201
2301
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Birmingham, Alabama 35249
1777
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Birmingham, AL
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Boston, Massachusetts 02115
2578
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Boston, MA
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Boston, Massachusetts 02115
2578
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Boston, MA
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Boston, Massachusetts 02115
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Boston, MA
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Carmel, Indiana 46032
1793
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Carmel, IN
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Chapel Hill, North Carolina 27599
2194
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Chapel Hill, NC
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Cincinnati, Ohio 45229
1880
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Cincinnati, OH
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Cincinnati, Ohio 45229
1880
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Cleveland, Ohio 44195
2036
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Cleveland, OH
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Columbus, Ohio 43219
1965
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Dallas, Texas 75230
1223
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Detroit, Michigan 48202
1965
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Detroit, MI
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Gainesville, Florida 32610
2105
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Houston, Texas 77030
1357
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Houston, TX
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Iowa City, Iowa 52242
1528
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Iowa City, IA
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Jacksonville, Florida 32207
2131
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Kansas City, Kansas 66160
1339
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La Jolla, California 92093
93
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Los Angeles, California 90025
24
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Milwaukee, Wisconsin 53215
1726
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Mobile, Alabama 36617
1754
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Mobile, AL
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Murray, Utah 84107
565
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Murray, UT
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Nashville, Tennessee 37203
1762
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New Hyde Park, New York 11040
2449
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New Orleans, Louisiana 70112
1655
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New York, New York 10032
2435
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New York, New York 10032
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New York, New York 10032
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Newark, New Jersey 07112
2422
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Oakbrook Terrace, Illinois 60181
1712
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Omaha, Nebraska 68131
1299
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Orlando, Florida 32806
2186
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Philadelphia, Pennsylvania 19104
2373
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Phoenix, Arizona 85012
343
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Pittsburgh, Pennsylvania 15213
2121
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Pittsburgh, Pennsylvania 15213
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Portland, Maine 04101
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Portland, Oregon 97227
829
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Providence, Rhode Island 02903
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Richmond, Virginia 23298
2269
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Rochester, New York 14642
2244
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Sacramento, California 95815
365
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St. Louis, Missouri 63110
1570
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Temple, Texas 76508
1217
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Torrance, California 90502
22
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Troy, Michigan 48085
1965
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Tucson, Arizona 85724
427
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Weston, Florida 33331
2303
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