CClinicalTrials.gg
Status unknownNCT03402191Updated Aug 27, 2018

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

A Phase 4 interventional study of L-arginine and Sildenafil in Thalassemia, sponsored by Sherief Abd-Elsalam. Status unknown at 1 site in Egypt. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2018-08-27.

Sponsored by Sherief Abd-Elsalam · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
6 Years to 18 Years
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

03

Who can participate

Ages eligible
6 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Children with thalassemia and pulmonary hypertension.

Exclusion criteria

Exclusion Criteria:

  • Rheumatic heart diseases.
  • Other comorbid disease
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    L-arginine

    l-arginine for pulmonary hypertension in patients with thalassemia.

    Drug: L-arginine

  • Active comparator
    Sildenafil

    Sildenafil for pulmonary hypertension in patients with thalassemia.

    Drug: Sildenafil

  • No intervention
    Control

    No pulmonary hypertension

Interventions

  • DrugL-arginine

    l-arginine for thalassemia with pulmonary hypertension

  • DrugSildenafil

    Sildenafil for thalassemia with pulmonary hypertension

    Also known as: Viagra

05

What researchers measure

Primary outcomes

  1. Number of patients with improvement of pulmonary hypertension

    patients with improvement of pulmonary hypertension

    Time frame: 6 months

06

Study locations

1 of 1 sites recruiting
  • Sherief Abd-Elsalam
    Tanta, Egypt
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03402191
Lead sponsor
Sherief Abd-Elsalam
Responsible party
Sherief Abd-Elsalam (PhDTropical Medicine, Tanta University) — Sponsor-investigator
First posted
Jan 18, 2018
Start date
Jul 2016
Primary completion
Dec 2023 (estimated)
Completion
Dec 2023 (estimated)
Last update
Aug 27, 2018

Study contacts

Sherief Abd-Elsalam, MD
Contact
sheriefabdelsalam@yahoo.com
00201095159522
Sahar El-Haggar, Prof
principal investigator · Tanta University - Faculty of Pharmacy
Mohamed El-Shanshoury, Prof
study director · Tanta University Pediatrics Department
Osama Abd-rab El-Rasol, Prof
study chair · Tanta University Pediatrics Department
Tarek Mostafa, Ass Prof
study chair · Tanta University-Faculty of pharmacy
Eman El-Khateeb, Msc
study chair · Tanta University-Faculty of pharmacy

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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