Tadalafil and Sildenafil for Duchenne Muscular Dystrophy

Completed · Early Phase 1

Conditions studied: Duchenne Muscular Dystrophy

In brief

This study, supported by Parent Project Muscular Dystrophy, will determine if tadalafil or sildenafil can improve muscle blood flow during exercise in boys with Duchenne muscular dystrophy.

Key facts

Study ID

NCT01359670

Run by

Cedars-Sinai Medical Center

People needed

30

Starts

2011-05-01

Expected to finish

2013-05-01

Last updated by the study team

2020-01-14

Who can join

Age: 7 and older, up to 15. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of DMD confirmed by muscle biopsy or DNA analysis
• Age 7-15y
• Ambulatory
• No clinical evidence of heart failure

You may not qualify if…

• Hypertension, diabetes, or heart failure by standard clinical criteria
• Elevated BNP level (>100 pg/ml)
• LVEF < 50%
• Wheelchair bound
• Cardiac rhythm disorder, specifically: rhythm other than sinus, SVT, atrial fibrillation, ventricular tachycardia
• Continuous ventilatory support
• Liver disease
• Renal impairment
• Contraindications to tadalafil or sildenafil (use of nitrates, alpha-blockers, CYP3A inhibitors, amlodipine, or other PDE5A inhibitors)

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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