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Sildenafil to Improve Exercise Capacity in People With Thalassemia and Pulmonary Hypertension

NCT00872170 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2014-02-21

Study results available
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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.

Conditions

Interventions

DRUG

Sildenafil

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

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Carelon Research

    lead OTHER

Principal Investigators

  • Ellis Neufeld, MD, PhD · Boston Children's Hospital

  • Claudia Morris, MD · Children's Hospital and Research Institute Oakland

  • Charles Quinn, MD · University of Texas, Southwestern Medical Center at Dallas

  • Patricia Giardina, MD · Weill Medical College of Cornell

  • Janet Kwiatkowski, MD · Children's Hospital of Philadelphia

  • Nancy Olivieri, MD · Toronto General Hospital

  • John Porter, MD · University College, London

  • Ali Taher, MD · American University of Beirut Medical Center- Lebannon

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-06-30
Completion
2010-11-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00872170 on ClinicalTrials.gov