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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01366209
First received: June 2, 2011
Last updated: May 7, 2015
Last verified: May 2015
Results First Received: February 27, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Idiopathic Pulmonary Fibrosis
Interventions: Drug: Pirfenidone
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Active Arm Pirfenidone: Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.
Placebo Arm Placebo: Placebo equivalent given as 3 divided doses 3 times per day.

Participant Flow:   Overall Study
    Active Arm   Placebo Arm
STARTED   278   277 
COMPLETED   243 [1]   241 
NOT COMPLETED   35   36 
Adverse Event                6                7 
Withdrawal by Subject                4                4 
Death                12                19 
Lung transplantation                6                1 
Lost to Follow-up                2                1 
Physician Decision                1                0 
Sponsors decision                0                1 
Withdrew consent                4                3 
[1] Participants completing study assessment at Week 52 were completers, even if treatment was withdrawn



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Active Arm Pirfenidone: Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.
Placebo Arm Placebo: Placebo equivalent given as 3 divided doses 3 times per day.
Total Total of all reporting groups

Baseline Measures
   Active Arm   Placebo Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 278   277   555 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   73   88   161 
>=65 years   205   189   394 
Gender 
[Units: Participants]
     
Female   56   64   120 
Male   222   213   435 
Region of Enrollment 
[Units: Participants]
     
United States   187   184   371 
Australia   33   31   64 
Brazil   15   16   31 
Croatia   1   1   2 
Israel   11   9   20 
Mexico   12   5   17 
New Zealand   1   3   4 
Peru   18   26   44 
Singapore   0   2   2 


  Outcome Measures

1.  Primary:   Change in Percent Predicted Forced Vital Capacity (%FVC) From Baseline to Week 52   [ Time Frame: 52 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann-LaRoche
phone: 800-821-8590
e-mail: genentech@druginfo.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01366209     History of Changes
Other Study ID Numbers: PIPF-016
Study First Received: June 2, 2011
Results First Received: February 27, 2015
Last Updated: May 7, 2015
Health Authority: United States: Food and Drug Administration