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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01178073




Registration number
NCT01178073
Ethics application status
Date submitted
15/07/2010
Date registered
9/08/2010
Date last updated
13/09/2017

Titles & IDs
Public title
A Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)
Scientific title
AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)
Secondary ID [1] 0 0
112565
Universal Trial Number (UTN)
Trial acronym
AMBITION
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension, Pulmonary 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ambrisentan
Treatment: Drugs - tadalafil

Active comparator: Combination ambrisentan + tadalafil - ambrisentan + tadalafil

Active comparator: Monotherapy ambrisentan - ambrisentan

Active comparator: Monotherapy tadalafil - tadalafil


Treatment: Drugs: ambrisentan
ambrisentan (target dose: 10mg)

Treatment: Drugs: tadalafil
tadalafil (target dose: 40mg)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
From Baseline up to the Final Assessment Visit (FAV) (average of 609 days)
Secondary outcome [1] 0 0
Percent Change From Baseline in the N-Terminal Pro-B-Type Natriuretic Peptide at Week 24
Timepoint [1] 0 0
Baseline and Week 24
Secondary outcome [2] 0 0
Percentage of Participants With a Satisfactory Clinical Response at Week 24
Timepoint [2] 0 0
Baseline and Week 24
Secondary outcome [3] 0 0
Change From Baseline in the 6 Minute Walk Distance Test at Week 24
Timepoint [3] 0 0
Baseline and Week 24
Secondary outcome [4] 0 0
Change From Baseline in the World Health Organization Functional Class at Week 24
Timepoint [4] 0 0
Baseline and Week 24
Secondary outcome [5] 0 0
Change From Baseline in Borg Dyspnea Index at Week 24
Timepoint [5] 0 0
Baseline (BL) and Week 24

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/07/2014
Sample size
Target
Accrual to date
Final
610
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Camperdown
Recruitment hospital [2] 0 0
GSK Investigational Site - Darlinghurst
Recruitment hospital [3] 0 0
GSK Investigational Site - Chermside
Recruitment hospital [4] 0 0
GSK Investigational Site - Hobart
Recruitment hospital [5] 0 0
GSK Investigational Site - Melbourne
Recruitment hospital [6] 0 0
GSK Investigational Site - Perth
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
4032 - Chermside
Recruitment postcode(s) [4] 0 0
7000 - Hobart
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment postcode(s) [6] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Arizona
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United States of America
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California
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United States of America
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Colorado
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Florida
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United States of America
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Georgia
Country [7] 0 0
United States of America
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Illinois
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Indiana
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Iowa
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Kansas
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United States of America
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Louisiana
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Maine
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United States of America
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Maryland
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Massachusetts
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Michigan
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Missouri
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Nebraska
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New Jersey
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New York
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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Rhode Island
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Tennessee
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Texas
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Utah
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Virginia
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Wisconsin
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Austria
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Innsbruck
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Austria
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Vienna
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Belgium
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Brussels
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Belgium
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Leuven
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Canada
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Alberta
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British Columbia
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Canada
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Manitoba
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Ontario
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Canada
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Quebec
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France
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Brest
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Bron
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La Tronche
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Le Kremlin-Bicêtre cedex
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Lille
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France
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Marseille cedex 20
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France
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Montpellier cedex 5
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France
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Pessac cedex
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France
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Saint Pierre cedex
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France
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Toulouse cedex 9
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Vandoeuvre-les-Nancy
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Germany
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Baden-Wuerttemberg
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Bayern
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Germany
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Hessen
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Mecklenburg-Vorpommern
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Germany
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Niedersachsen
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Germany
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Sachsen
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Germany
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Berlin
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Germany
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Hamburg
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Greece
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Alexandroupolis
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Athens
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Greece
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Thessaloniki
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Italy
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Emilia-Romagna
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Italy
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Lazio
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Italy
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Sardegna
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Italy
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Sicilia
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Italy
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Toscana
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Fukuoka
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Hokkaido
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Japan
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Tokyo
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Amsterdam
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Maastricht
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Rotterdam
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Barcelona
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Córdoba
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Spain
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L'Hospitalet de Llobregat
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Spain
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Madrid
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Spain
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Majadahonda (Madrid)
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Spain
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Malaga
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Spain
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Palma de Mallorca
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Santander
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Spain
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Santiago de Compostela
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Spain
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Sevilla
Country [85] 0 0
Spain
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Toledo
Country [86] 0 0
Spain
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Valencia
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Sweden
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Göteborg
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Sweden
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Linköping
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Lund
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Sweden
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Umeå
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Sweden
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Uppsala
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United Kingdom
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Cambridgeshire
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United Kingdom
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Clydebank
Country [94] 0 0
United Kingdom
State/province [94] 0 0
London
Country [95] 0 0
United Kingdom
State/province [95] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Gilead Sciences
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01178073