Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF) (ASCEND)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
InterMune
ClinicalTrials.gov Identifier:
NCT01366209
First received: June 2, 2011
Last updated: March 21, 2014
Last verified: March 2014

June 2, 2011
March 21, 2014
June 2011
February 2014   (final data collection date for primary outcome measure)
Change in percent predicted forced vital capacity (%FVC) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01366209 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)
A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (ASCEND Trial)

PIPF-016 (ASCEND) is a Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the Efficacy and Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis. The study objectives are to confirm the treatment effect of pirfenidone compared with placebo on change in percent predicted forced vital capacity (%FVC) in patients with idiopathic pulmonary fibrosis (IPF), and to confirm the safety of treatment with pirfenidone compared with placebo in patients with IPF.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Idiopathic Pulmonary Fibrosis
  • Drug: Pirfenidone
    Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.
  • Drug: Placebo
    Placebo equivalent given as 3 divided doses 3 times per day.
  • Active Comparator: Active Arm
    Intervention: Drug: Pirfenidone
  • Placebo Comparator: Placebo Arm
    Intervention: Drug: Placebo
King TE Jr, Bradford WZ, Castro-Bernardini S, Fagan EA, Glaspole I, Glassberg MK, Gorina E, Hopkins PM, Kardatzke D, Lancaster L, Lederer DJ, Nathan SD, Pereira CA, Sahn SA, Sussman R, Swigris JJ, Noble PW; ASCEND Study Group. A phase 3 trial of pirfenidone in patients with idiopathic pulmonary fibrosis. N Engl J Med. 2014 May 29;370(22):2083-92. doi: 10.1056/NEJMoa1402582. Epub 2014 May 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
555
February 2014
February 2014   (final data collection date for primary outcome measure)

Select Inclusion Criteria:

  1. Diagnosis of definite or probable Idiopathic Pulmonary Fibrosis (IPF) per the ATS 2011 Guidelines up to 48 months before randomization
  2. Age 40 to 80 at randomization
  3. Percent Forced Vital Capacity (%FVC) ≥50% and ≤90% at screening
  4. Percent Carbon Monoxide Diffusing Capacity (%DLCO) ≥30% and ≤90% at screening

Select Exclusion Criteria:

  1. Forced expiratory volume in one second (FEV1)/FVC ratio <0.8 after administration of bronchodilator at Screening
  2. Expected to receive a lung transplant within 1 year from randomization or, for patients at sites in the United States, on a lung transplant waiting list at randomization
  3. Known explanation for interstitial lung disease
  4. History of asthma or chronic obstructive pulmonary disease
  5. Active infection
  6. Ongoing IPF treatments including investigational therapy, immunosuppressants, and cytokine modulating agents
  7. History of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within the previous 6 months
Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01366209
PIPF-016
Yes
InterMune
InterMune
Not Provided
Study Chair: For additional information, call InterMune Medical Information Telephone: 1-888-486-6411 InterMune
InterMune
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP