L-arginine Versus Sildenafil in Children With Beta Thalassemia Associated With Pulmonary Hypertension

August 23, 2018 updated by: Sherief Abd-Elsalam

Comparative Clinical Study Evaluating the Effect of L-arginine Versus Sildenafil in Children With Beta Thalassemia Associated With Pulmonary Hypertension

This study compares L-arginine Versus Sildenafil as treatment for pulmonary hypertension in Children with Beta Thalassemia

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study focuses on different lines of treatment for pulmonary hypertension in children with thalassemia as this study discusses the Effect of L-arginine Versus Sildenafil in Children with Beta Thalassemia Associated with Pulmonary Hypertension

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Tanta, Egypt
        • Recruiting
        • Sherief Abd-Elsalam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children with thalassemia and pulmonary hypertension.

Exclusion Criteria:

  • Rheumatic heart diseases.
  • Other comorbid disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: L-arginine
l-arginine for pulmonary hypertension in patients with thalassemia.
Drug: L-arginine
l-arginine for thalassemia with pulmonary hypertension
Active Comparator: Sildenafil
Sildenafil for pulmonary hypertension in patients with thalassemia.
Drug: Sildenafil
Sildenafil for thalassemia with pulmonary hypertension
Other Names:
  • Viagra
No Intervention: Control
No pulmonary hypertension

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with improvement of pulmonary hypertension
Time Frame: 6 months
patients with improvement of pulmonary hypertension
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sherief Abd-Elsalam

Investigators

  • Principal Investigator: Sahar El-Haggar, Prof, Tanta University - Faculty of Pharmacy
  • Study Director: Mohamed El-Shanshoury, Prof, Tanta University Pediatrics Department
  • Study Chair: Osama Abd-rab El-Rasol, Prof, Tanta University Pediatrics Department
  • Study Chair: Tarek Mostafa, Ass Prof, Tanta University-Faculty of pharmacy
  • Study Chair: Eman El-Khateeb, Msc, Tanta University-Faculty of pharmacy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

January 9, 2018

First Submitted That Met QC Criteria

January 16, 2018

First Posted (Actual)

January 18, 2018

Study Record Updates

Last Update Posted (Actual)

August 27, 2018

Last Update Submitted That Met QC Criteria

August 23, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Prof Elshanshoury

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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