A Study of Tadalafil for Duchenne Muscular Dystrophy
Public ClinicalTrials.gov record NCT01865084. 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 Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Tadalafil for Duchenne Muscular Dystrophy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The main purpose of this study is to determine if tadalafil can slow the decline in walking ability of boys who have Duchenne muscular dystrophy (DMD). The study will also assess the safety of tadalafil and any side effects that might be associated with it in boys who have DMD. Participants will receive study treatment (tadalafil or placebo) for the first 48 weeks of the study, and can then continue into an open label extension (OLE) that consists of two periods during which all participants will receive tadalafil. In OLE period 1, all participants will receive tadalafil for 48 weeks. Participants completing OLE period 1 will continue into OLE period 2 and will receive tadalafil for at least another 48 weeks.
Study identification
- NCT ID
- NCT01865084
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 331 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 7 Years to 14 Years
- Sex
- Male
- 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
- Sep 2013 (Type not available)
- Primary completion
- Dec 2015 (Actual)
- Completion
- Mar 2016 (Actual)
- Last update posted
- Oct 9, 2019
2013 – 2016
United States locations
- U.S. sites
- 23
- U.S. states
- 16
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | — |
| University of California, Davis - Health Systems | Sacramento | California | 95817 | — |
| Children's Hospital | Aurora | Colorado | 80045 | — |
| University of Florida Health Science Center | Gainesville | Florida | 32610 | — |
| NW Florida Clinical Research Group | Gulf Breeze | Florida | 32561 | — |
| Nemours Children's Hospital | Orlando | Florida | 32827 | — |
| Ann and Robert Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| Washington University Medical Center | St Louis | Missouri | 63110 | — |
| Carolinas Healthcare System | Charlotte | North Carolina | 28203 | — |
| Duke University Medical Center | Durham | North Carolina | 27705 | — |
| Childrens Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| Pennsylvania State University College of Medicine | Hershey | Pennsylvania | 17033 | — |
| Childrens Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Childrens Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Children's Medical Center Dallas | Dallas | Texas | 75207 | — |
| Univ of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | — |
| University of Utah School of Medicine | Salt Lake City | Utah | 84132 | — |
| Children of the King's Daughters | Norfolk | Virginia | 23510 | — |
| Seattle Children's Hospital Research Foundation | Seattle | Washington | 98105 | — |
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 39 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01865084, 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 Oct 9, 2019 · Synced Oct 29, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01865084 live on ClinicalTrials.gov.