Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF) (ASCEND)
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ClinicalTrials.gov Identifier: NCT01366209 |
Recruitment Status :
Completed
First Posted : June 3, 2011
Results First Posted : March 12, 2015
Last Update Posted : April 5, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Idiopathic Pulmonary Fibrosis | Drug: Pirfenidone Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 555 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (ASCEND Trial) |
Study Start Date : | June 2011 |
Actual Primary Completion Date : | February 2014 |
Actual Study Completion Date : | February 2014 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Active Arm |
Drug: Pirfenidone
Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day. |
Placebo Comparator: Placebo Arm |
Drug: Placebo
Placebo equivalent given as 3 divided doses 3 times per day. |
- Change in Percent Predicted Forced Vital Capacity (%FVC) From Baseline to Week 52 [ Time Frame: 52 weeks ]

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Ages Eligible for Study: | 40 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Select Inclusion Criteria:
- Diagnosis of idiopathic pulmonary fibrosis (IPF), consistent with the ATS 2011 Guidelines, of 6-48 months' duration
- Age 40 to 80 at randomization
- Percent Forced Vital Capacity (%FVC) ≥50% and ≤90% at screening
- Percent Carbon Monoxide Diffusing Capacity (%DLCO) ≥30% and ≤90% at screening
Select Exclusion Criteria:
- Forced expiratory volume in one second (FEV1)/FVC ratio <0.8 after administration of bronchodilator at Screening
- 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
- Known explanation for interstitial lung disease
- History of asthma or chronic obstructive pulmonary disease
- Active infection
- Ongoing IPF treatments including investigational therapy, immunosuppressants, and cytokine modulating agents
- History of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within the previous 6 months

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01366209
United States, California | |
InterMune Inc. | |
Brisbane, California, United States, 94005 |
Study Chair: | For additional information, call InterMune Medical Information Telephone: 1-888-486-6411 | InterMune |
Responsible Party: | Genentech, Inc. |
ClinicalTrials.gov Identifier: | NCT01366209 |
Other Study ID Numbers: |
PIPF-016 |
First Posted: | June 3, 2011 Key Record Dates |
Results First Posted: | March 12, 2015 |
Last Update Posted: | April 5, 2017 |
Last Verified: | March 2017 |
Pirfenidone ASCEND IPF FVC |
Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Fibrosis Pathologic Processes Lung Diseases, Interstitial Lung Diseases Respiratory Tract Diseases Pirfenidone Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Anti-Inflammatory Agents Antirheumatic Agents Antineoplastic Agents |