Nintedanib Twice Daily vs Placebo in Patients Diagnosed With Idiopathic Pulmonary Fibrosis (IPF)
Public ClinicalTrials.gov record NCT01979952. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Six Month Double Blind Randomized Placebo Controlled Trial Followed by Each Arm Being Converted to Oral Nintedanib 150 mg Twice Daily Comparing the Effect on High Resolution Computerized Tomography Quantitative Lung Fibrosis Score, Lung Function, Six Minute Walk Test Distance and St. George's Respiratory Questionnaire After Six Months of Treatment in Patients With Idiopathic Pulmonary Fibrosis With Continued Evaluations Over a Period of up to Eighteen Months
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is an 6 month multi-centre, prospective, randomized, placebo controlled, double blind clinical trial followed by conversion of each arm to active nintedanib for an additional 6 months comparing the effect of nintedanib 150mg bis in die (BID twice daily) on the progression of IPF measured by using High Resolution Computerized Tomography(HRCT), lung function, functional component (6MWT), biomarkers, and PRO component (PROs) with continued treatment and assessments for up to 18 months.
Study identification
- NCT ID
- NCT01979952
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 113 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 40 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 25, 2013
- Primary completion
- Oct 26, 2016
- Completion
- Oct 26, 2016
- Last update posted
- Apr 16, 2018
2013 – 2016
United States locations
- U.S. sites
- 11
- U.S. states
- 11
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Western CT Medical Group, P.C. | Danbury | Connecticut | 06810 | — |
| Clinical Research Center Sarasota Memorial Hosptial | Sarasota | Florida | 34239 | — |
| Chest Medicine Clinical Services | Skokie | Illinois | 60076 | — |
| Baptist Health Lexington | Lexington | Kentucky | 40503 | — |
| Minnesota Lung Research | Minneapolis | Minnesota | 55407 | — |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| Winthrop University Hospital | Mineola | New York | 11501 | — |
| ID Clinical Research, LTD | Toledo | Ohio | 43608 | — |
| The Oregon Clinic | Portland | Oregon | 97220 | — |
| Lowcountry Lung and Crit Care | Charleston | South Carolina | 29406 | — |
| Annette C & Harold C Simmons Transplant Institute | Dallas | Texas | 75246 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 14 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01979952, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 16, 2018 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01979952 live on ClinicalTrials.gov.