CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 27 enrolled
Drug / intervention
Sildenafildrug
Likely dose
Sildenafil 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00872170
NCT00872170Phase 3Completed
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Pilot of Oral Sildenafil for the Treatment of Pulmonary Hypertension in Thalassemia With Comparison to Controls

Carelon Research·interventional·Posted Mar 31, 2009·Updated Feb 21, 2014

In Brief

A Phase 3 clinical trial evaluating Sildenafil for Thalassemia and Hypertension, Pulmonary. Completed, enrolled 27 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsThalassemia, Hypertension, Pulmonary
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 31, 2009
Enrollment StartMar 1, 2009
Primary CompletionJun 1, 2010
Study CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.3 years ago

Interventions

Sildenafildrug

Participants will receive sildenafil for 12 weeks with the following therapy: 50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg