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Clinical Trials/EUCTR2008-004405-34-ES
EUCTR2008-004405-34-ESActive, not recruitingNot Applicable

ARTEMIS: A Phase 3, Randomized, Double-Blind,Placebo-Controlled, Multi-Center, Parallel-Group,Event-Driven Study to Evaluate the Efficacy and Safety ofAmbrisentan in Subjects with Early Idiopathic PulmonaryFibrosis (IPF)ARTEMIS: Estudio de fase 3, aleatorizado, doble ciego, controlado con placebo, multicéntrico, con grupos paralelos, en función de eventos, para evaluar la eficacia y seguridad de ambrisentan en sujetos con fibrosis pulmonar idiopática temprana (FPI). - ARTEMIS

Gilead Sciences Incorporated0 sites600 target enrollmentStarted: January 28, 2009Last updated:
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Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
600
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1. Male or females from 40 to 80 years of age
  • •2. Diagnosis of Idiopathic Pulmonary Fibrosis (IPF) based on the following criteria in
  • •accordance with ATS-ERS guidelines for diagnosing IPF:
  • •— Definite or probable UIP confirmed on SLB by core pathologist
  • •— In absence of SLB, HRCT scan showing definite findings for IPF (bibasilar
  • •reticular abnormalities with minimal ground glass opacities) as determined by core
  • •and three of the following minor criteria”:
  • •— Age > 50 years
  • •— Insidious onset of otherwise unexplained dyspnea on exertion
  • •— Duration of illness = 3 months
  • •— Bibasilar, inspiratory crackles
  • •Within 90 days of study enrollment, diagnosis must be confirmed by HRCT
  • •3. Honeycombing = 5% as assessed on HRCT; HRCT results will undergo a core review
  • •process (please see Section 7.4 of the protocol) to confirm diagnosis.
  • •4. Willingness to undergo RHC at baseline and at Visit 7 or end of study (EOS)
  • •5. Willingness and ability to comply with required monitoring of liver function every
  • •28 days. LFTs include serum ALT, AST, alkaline phosphatase, gamma glutamyl
  • •transferase (GGT), and total bilirubin concentrations
  • •6. Forced vital capacity (FVC) > 50 to = 90% of predicted with a ratio of
  • •FEV1 (L) / FVC (L) = 0.7. Pulmonary function tests must be completed no more than
  • •90 days before enrollment
  • •7. Ability to perform and complete 6MWT at screening
  • •8. Negative serum pregnancy test at screening and negative urine pregnancy test at
  • •randomization for female subjects of childbearing potential (defined in Section 6.3 of the protocol).
  • •9. Female subjects of childbearing potential must be willing to use at least two reliable
  • •methods of contraception throughout their participation in the study and 30 days after
  • •discontinuation of IMP unless the subject has had a tubal sterilization, is
  • •postmenopausal, or has a Copper T 380A intrauterine device (IUD) or LNg 20 IUD
  • •inserted, in which case no other contraception is needed. Subjects of childbearing
  • •potential must also be willing to undergo pregnancy tests every 28 days.
  • •10. Male subjects must be capable of understanding and acknowledging potential risks of
  • •testicular tubular atrophy and infertility associated with taking this IMP as described
  • •in the Informed Consent Form (ICF)
  • •11. Competency to understand the information given in the Institutional Review Board
  • •(IRB) or Independent Ethics Committee (IEC) approved ICF. Subjects must sign the
  • •form prior to the initiation of any study procedures, unless the assessment is
  • •performed in the routine care for this disease
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • •1. Diagnosis of an ILD or restrictive lung disease other than UIP or IPF
  • •2. Obstructive lung disease as determined by evidence of airflow obstruction on HRCT
  • •or physiologic criteria including:
  • •FEV1/FVC ratio < 0.7
  • •RV > 120% by plethysmography or significant (verified by radiologist) emphysema on HRCT if plethysmography not available
  • •Evidence of reactive airway disease by change in FEV1 of > 12% following bronchodilator challenge
  • •3. Evidence of sustained improvement of IPF condition defined as improvement from
  • •pre-therapy PFTs observed with two or more successive post-therapy PFTs over the
  • •year prior to randomization
  • •4. Condition(s) that is or are a contraindication for RHC including:
  • •Tricuspid or pulmonary valve stenosis
  • •Prosthetic tricuspid or pulmonary valve
  • •Right atrial or right ventricular masses
  • •Cyanotic heart disease
  • •Allergy to latex or catheter material
  • •Previous pneumonectomy.
  • •5. Active or recent (= 60 days prior to enrollment) pulmonary or upper respiratory tract
  • •6. Hospitalization within 60 days of screening for an acute exacerbation of IPF
  • •7. Chronic heart failure (NYHA class III/IV) or known left ventricular ejection
  • •fraction < 25%
  • •8. Chronic treatment with the following drugs prescribed for IPF (within 4 weeks of
  • •randomization):oral corticosteroids (> 20 mg/day of prednisone or equivalent),
  • •immunosuppressive or cytotoxic drugs, antifibrotic drugs, chronic use of Nacetylcysteine
  • •(prescribed for IPF)
  • •9. Acute or chronic impairment (other than dyspnea) which limits the ability to comply
  • •with study requirements and procedures including the 6MWT
  • •10. Treatment with ambrisentan in a clinical study or with commercial product
  • •11. Treatment with an approved or experimental ERA within 30 days prior to
  • •randomization
  • •12. Chronic use of sildenafil or other phosphodiesterase type 5 (PDE-5) inhibitor for
  • •pulmonary hypertension
  • •13. Chronic treatment with immunosuppressive, cytotoxic, or antifibrotic drugs including
  • •pirfenidone, D-penicillamine, colchicine, TNF-a antagonists, imatinib,
  • •interferon-gamma, cyclophosphamide, cyclosporine A, or azathioprine within 30 days
  • •of randomization (Section 5.4 of the protocol)
  • •14. Prior ERA treatment discontinued for any toxicity
  • •15. ALT or AST > 1.5 × ULN at screening
  • •16. Hemoglobin concentration < 75% of LLN at screening
  • •17. Serum creatinine = 2.5 mg/dL (221 µmol/L) or subject requires hemodialysis,
  • •peritoneal dialysis or hemofiltration
  • •18. Systolic blood pressure < 85 mmHg
  • •19. History of malignancies within the past 5 years, with the exception of basal cell
  • •carcinoma of the skin or successfully treated in situ carcinoma of the cervix
  • •20. Female who is pregnant or nursing
  • •21. Known history of alcohol abuse within 1 year of enrollment
  • •22. Participation in a clinical study involving another investigational drug or device within 28 days of screening
  • •23. Comorbid condition or illness limiting life expectancy to < 1 year at time of screening
  • •24. Serious or active medical or psychiatric condition which, in the opinion of the Investigator, would interfere with subject treatment, assessment or compliance with
  • •the protocol

Investigators

Sponsor
Gilead Sciences Incorporated

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