Sildenafil to Improve Exercise Capacity in People With Thalassemia and Pulmonary Hypertension
Completed · Phase 2/Phase 3
Conditions studied: Thalassemia, Hypertension, Pulmonary
In brief
Thalassemia is an inherited blood disorder that can result in mild to severe anemia. Many people with thalassemia also have pulmonary hypertension, which is high blood pressure in the arteries in the lungs. This study will evaluate the safety and effectiveness of the medication sildenafil at reducing blood pressure in the lungs of people with thalassemia and pulmonary hypertension.
Key facts
- Study ID
- NCT00872170
- Run by
- Carelon Research
- People needed
- 27
- Starts
- 2009-03-01
- Expected to finish
- 2010-11-01
- Last updated by the study team
- 2014-02-21
Who can join
Age: 7 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Pregnant or breastfeeding
- Hypersensitivity to arginine or sildenafil, based on prior use
- Any of the following medical conditions:
- Severe kidney insufficiency, defined as use of hemodialysis or serum creatinine at levels greater than 2.5 mg/dL at the time of screening
- Cardiac disease with adjustment of cardiac medications in the 60 days before study entry
- Symptomatic coronary artery disease, as indicated by a history of chest pain, angina, claudication, or surgery to treat coronary artery disease in the 1 year before study entry
- Stroke, defined as a new focal neurological deficit lasting more than 24 hours in the 45 days before study entry
- New diagnosis of pulmonary embolism by ventilation-perfusion scan, angiography, or any other technique in the 90 days before study entry
- History of retinal detachment or retinal hemorrhage in the 180 days before study entry
- Use of nitrate-based vasodilators, prostacyclin (inhaled, subcutaneous, or intravenous), endothelin antagonists, or any other medication for pulmonary hypertension
- Acute asthma exacerbation requiring use of prednisone in the 60 days before study entry
- Initiation or dosage increase of calcium channel blockers in the 30 days before study entry
- Initiation of any other cardiac or pulmonary medication in the 90 days before study entry
- Presence of any other condition, which in the opinion of the investigator, would make the person unsuitable for enrollment or could interfere with compliance in the study, including but not limited to alcohol or drug abuse
- No measurable TRjet on Doppler echocardiography (i.e., presence of pulmonary hypertension cannot be confirmed or ruled out)
Where it is running
- Children's Hospital and Research Institute Oakland — Oakland, California, United States
Full record on ClinicalTrials.gov
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